| Regulatory source |
- |
0.0006 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:0.00060 8 13 333 Hand soap 0.03 0.00659 8 1 214 Shower gel 0.03 0.01919 8 417 Aggregated exposure 0.48206 8 17 Aggregated exposure not including body lotion 0.107 8 75 With the exception of body lotion, each separate product type has a MoS above 100. Aggregated exposure to triclosan results in a MoS lower than 100 due to the contribution of triclosan in body lotions and mouthwash. Dermal TCC as a preservative (µg/kg bw/d) Dermal TCC in rinse -off products (µg/kg bw/d) Oral * (µg/kg bw/d) Aggregated (µg/kg bw/d) NOAEL Adj (µg/kg bw/d) MOS Infants 0.5 -1 55.09 17.73 45.45 118.27 6750 57 Toddlers 1-3 51.76 17.14 33.61 102.51 6750 66 Children 3-6 48.07 13.51 17.32 78.90 6750 86 Children 6-10 48.07 13.51 17.32 78.90 6750 86 Adolescents 10-14 41.59 11.06 6.34 58.99 6750 114 Adolescents 14-18 38.86 10.18 4.49 53.53 6750 126 Age categories; EFFECT=0.00060 8 13 333 Hand soap 0.03 0.00659 8 1 214 Shower gel 0.03 0.01919 8 417 Aggregated exposure 0.48206 8 17 Aggregated exposure not including body lotion 0.107 8 75 With the exception of body lotion, each separate product type has a MoS above 100. Aggregated exposure to triclosan results in a MoS lower than 100 due to the contribution of triclosan in body lotions and mouthwash. Dermal TCC as a preservative (µg/kg bw/d) Dermal TCC in rinse -off products (µg/kg bw/d) Oral * (µg/kg bw/d) Aggregated (µg/kg bw/d) NOAEL Adj (µg/kg bw/d) MOS Infants 0.5 -1 55.09 17.73 45.45 118.27 6750 57 Toddlers 1-3 51.76 17.14 33.61 102.51 6750 66 Children 3-6 48.07 13.51 17.32 78.90 6750 86 Children 6-10 48.07 13.51 17.32 78.90 6750 86 Adolescents 10-14 41.59 11.06 6.34 58.99 6750 114 Adolescents 14-18 38.86 10.18 4.49 53.53 6750 126 Age categories; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"0.00060 8 13 333 Hand soap 0.03 0.00659 8 1 214 Shower gel 0.03 0.01919 8 417 Aggregated exposure 0.48206 8 17 Aggregated exposure not including body lotion 0.107 8 75 With the exception of body lotion, each separate product type has a MoS above 100. Aggregated exposure to triclosan results in a MoS lower than 100 due to the contribution of triclosan in body lotions and mouthwash. Dermal TCC as a preservative (µg/kg bw/d) Dermal TCC in rinse -off products (µg/kg bw/d) Oral * (µg/kg bw/d) Aggregated (µg/kg bw/d) NOAEL Adj (µg/kg bw/d) MOS Infants 0.5 -1 55.09 17.73 45.45 118.27 6750 57 Toddlers 1-3 51.76 17.14 33.61 102.51 6750 66 Children 3-6 48.07 13.51 17.32 78.90 6750 86 Children 6-10 48.07 13.51 17.32 78.90 6750 86 Adolescents 10-14 41.59 11.06 6.34 58.99 6750 114 Adolescents 14-18 38.86 10.18 4.49 53.53 6750 126 Age categories","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:0.00060 8 13 333 Hand soap 0.03 0.00659 8 1 214 Shower gel 0.03 0.01919 8 417 Aggregated exposure 0.48206 8 17 Aggregated exposure not including body lotion 0.107 8 75 With the exception of body lotion, each separate product type has a MoS above 100. Aggregated exposure to triclosan results in a MoS lower than 100 due to the contribution of triclosan in body lotions and mouthwash. Dermal TCC as a preservative (µg/kg bw/d) Dermal TCC in rinse -off products (µg/kg bw/d) Oral * (µg/kg bw/d) Aggregated (µg/kg bw/d) NOAEL Adj (µg/kg bw/d) MOS Infants 0.5 -1 55.09 17.73 45.45 118.27 6750 57 Toddlers 1-3 51.76 17.14 33.61 102.51 6750 66 Children 3-6 48.07 13.51 17.32 78.90 6750 86 Children 6-10 48.07 13.51 17.32 78.90 6750 86 Adolescents 10-14 41.59 11.06 6.34 58.99 6750 114 Adolescents 14-18 38.86 10.18 4.49 53.53 6750 126 Age categories","page":55,"route":"oral","species":"","study_id":"sccs_o_265_noael_043"} |
| Regulatory source |
- |
0.0321 |
mg/kg bw/d |
- |
oral |
chronic |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=0.0321; DOSE=mum systemic exposure dose, as presented in Table A2.; EFFECT=mum systemic exposure dose, as presented in Table A2. The results of the MOS calculations for the individual as well as the aggregate exposure scenarios are presented in Table A3. Table A3: Calculated Margins of Safety for uses of Triclocarban in liquid and bar soaps and shower gels Product Adults Bar Soap Exposure 0.0074 mg/kg bw/d MOS 912 Liquid Soap Exposure 0.0195 mg/kg bw/d MOS 346 Body Wash Exposure 0.0052 mg/kg bw/d MOS 1298 Aggregate Scenario Exposure 0.0321 mg/kg bw/d MOS 210 Based on the internal NOEL derived from the oral chronic feeding study and with respect to the oral absorption rate of 27%, the Margin of Safety in the aggregate scenario will be 210 for a 60 kg adult. As recent reports in literature point to a possible persistence of Triclocarban in the environment and despite of the low solubility in water, consideration should be given to the actual concentrations in these respects, followed by an appropriate risk assessment.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"mum systemic exposure dose, as presented in Table A2.","duration":"chronic","effect":"mum systemic exposure dose, as presented in Table A2. The results of the MOS calculations for the individual as well as the aggregate exposure scenarios are presented in Table A3. Table A3: Calculated Margins of Safety for uses of Triclocarban in liquid and bar soaps and shower gels Product Adults Bar Soap Exposure 0.0074 mg/kg bw/d MOS 912 Liquid Soap Exposure 0.0195 mg/kg bw/d MOS 346 Body Wash Exposure 0.0052 mg/kg bw/d MOS 1298 Aggregate Scenario Exposure 0.0321 mg/kg bw/d MOS 210 Based on the internal NOEL derived from the oral chronic feeding study and with respect to the oral absorption rate of 27%, the Margin of Safety in the aggregate scenario will be 210 for a 60 kg adult. As recent reports in literature point to a possible persistence of Triclocarban in the environment and despite of the low solubility in water, consideration should be given to the actual concentrations in these respects, followed by an appropriate risk assessment.","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.0321","page":33,"route":"oral","species":"","study_id":"sccp_o_016_noael_018"} |
| Regulatory source |
- |
=0.2 |
% |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 0.2; EFFECT=ocytes. Microscopic evaluation of dam mammary tissue revealed involution to be a secondary outcome of triclocarban exposure rather than a primary effect of compound administration. The authors concluded that these results demonstrate that gestational triclocarban exposure does not affect the ability of dams to carry offspring to term but triclocarban exposure during lactation has adverse consequences on the survival of offspring although the mechanism of reduced survival is currently unknown. Based on T3 levels: NOAEL = 0.2% w/w. Based on pup survival: LOAEL = 0.2% w/w corresponding to maternal serum levels of 134.6 ± 15.4 ng/mL on GD5. Ref.: Kennedy 2015 Using experimental rodent studies, low doses of triclocarban were reported to induce hepatic steatosis. It is plausible that this effect resulted from an ED mode of action involving changes in the expression levels of leptin and adiponectin and/or AhR activation. In vitro studies support also an interaction of triclocarban with AhR, which is known to be involved in metabolic; CITATION=Ref.: Kennedy 2015 Using experimental rodent studies, low doses of triclocarban were reported to induce hepatic steatosis; CITATION_NUMBERS=[2015]; REFERENCE=Ref.: Kennedy 2015 Using experimental rodent studies, low doses of triclocarban were reported to induce hepatic steatosis; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Kennedy 2015 Using experimental rodent studies, low doses of triclocarban were reported to induce hepatic steatosis","dose":"","duration":"","effect":"ocytes. Microscopic evaluation of dam mammary tissue revealed involution to be a secondary outcome of triclocarban exposure rather than a primary effect of compound administration. The authors concluded that these results demonstrate that gestational triclocarban exposure does not affect the ability of dams to carry offspring to term but triclocarban exposure during lactation has adverse consequences on the survival of offspring although the mechanism of reduced survival is currently unknown. Based on T3 levels: NOAEL = 0.2% w/w. Based on pup survival: LOAEL = 0.2% w/w corresponding to maternal serum levels of 134.6 ± 15.4 ng/mL on GD5. Ref.: Kennedy 2015 Using experimental rodent studies, low doses of triclocarban were reported to induce hepatic steatosis. It is plausible that this effect resulted from an ED mode of action involving changes in the expression levels of leptin and adiponectin and/or AhR activation. In vitro studies support also an interaction of triclocarban with AhR, which is known to be involved in metabolic","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"%","noael_value":"= 0.2","page":22,"route":"","species":"","study_id":"sccs_o_265_noael_014"} |
| Regulatory source |
- |
0.5 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:d soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Adolescents 10-14 0.03 0.02647 8 302 Adolescents 14-18 0.03 0.02451 8 326 Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories Age category Age (yrs) SEDoral SEDdermal SEDtotal NOAEL MoSoral MoSdermal MoStotal mg/kg bw/d Infants 0.5-1 0.06819 0.68675 0.75494 8 117 12 11 Toddler 1-3 0.05043 0.64705 0.69748 8 159 12 11 Children1 3-6 0.02598 0.52183 0.54781 8 308 15 15 Children2 6-10 0.20487 0.52183 0.72670 8 39 15 11 Adolescents 10-14 0.10905 0.41467 0.52372 8 73 19 15 Adolescents 14-18 0.07720 0.39029 0.46749 8 104 20 17 Aggregated exposure not including body lotion Infants 0.5-1 0.06819 0.04420 0.11239 8 117 181 71 Toddler 1-3 0.05043 0.04160 0.09203 8 159 192 87 Children1 3-6 0.02598; DOSE=Calculation of MoS for aggregated exposures of triclosan by age categories Age category Age (yrs) SEDoral SEDdermal SEDtotal NOAEL MoSoral MoSdermal MoStotal mg/kg bw/d Infants 0.5-1 0.06819 0.68675 0.75494 8 117 12 11 Toddler 1-3 0.05043 0.64705 0.69748 8 159 12 11 Children1 3-6 0.02598 0.52183 0.54781 8 308 15 15 Children2 6-10 0.20487 0.52183...; EFFECT=d soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Adolescents 10-14 0.03 0.02647 8 302 Adolescents 14-18 0.03 0.02451 8 326 Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories Age category Age (yrs) SEDoral SEDdermal SEDtotal NOAEL MoSoral MoSdermal MoStotal mg/kg bw/d Infants 0.5-1 0.06819 0.68675 0.75494 8 117 12 11 Toddler 1-3 0.05043 0.64705 0.69748 8 159 12 11 Children1 3-6 0.02598 0.52183 0.54781 8 308 15 15 Children2 6-10 0.20487 0.52183 0.72670 8 39 15 11 Adolescents 10-14 0.10905 0.41467 0.52372 8 73 19 15 Adolescents 14-18 0.07720 0.39029 0.46749 8 104 20 17 Aggregated exposure not including body lotion Infants 0.5-1 0.06819 0.04420 0.11239 8 117 181 71 Toddler 1-3 0.05043 0.04160 0.09203 8 159 192 87 Children1 3-6 0.02598; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Calculation of MoS for aggregated exposures of triclosan by age categories Age category Age (yrs) SEDoral SEDdermal SEDtotal NOAEL MoSoral MoSdermal MoStotal mg/kg bw/d Infants 0.5-1 0.06819 0.68675 0.75494 8 117 12 11 Toddler 1-3 0.05043 0.64705 0.69748 8 159 12 11 Children1 3-6 0.02598 0.52183 0.54781 8 308 15 15 Children2 6-10 0.20487 0.52183...","duration":"","effect":"d soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Adolescents 10-14 0.03 0.02647 8 302 Adolescents 14-18 0.03 0.02451 8 326 Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories Age category Age (yrs) SEDoral SEDdermal SEDtotal NOAEL MoSoral MoSdermal MoStotal mg/kg bw/d Infants 0.5-1 0.06819 0.68675 0.75494 8 117 12 11 Toddler 1-3 0.05043 0.64705 0.69748 8 159 12 11 Children1 3-6 0.02598 0.52183 0.54781 8 308 15 15 Children2 6-10 0.20487 0.52183 0.72670 8 39 15 11 Adolescents 10-14 0.10905 0.41467 0.52372 8 73 19 15 Adolescents 14-18 0.07720 0.39029 0.46749 8 104 20 17 Aggregated exposure not including body lotion Infants 0.5-1 0.06819 0.04420 0.11239 8 117 181 71 Toddler 1-3 0.05043 0.04160 0.09203 8 159 192 87 Children1 3-6 0.02598","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:d soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Adolescents 10-14 0.03 0.02647 8 302 Adolescents 14-18 0.03 0.02451 8 326 Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories Age category Age (yrs) SEDoral SEDdermal SEDtotal NOAEL MoSoral MoSdermal MoStotal mg/kg bw/d Infants 0.5-1 0.06819 0.68675 0.75494 8 117 12 11 Toddler 1-3 0.05043 0.64705 0.69748 8 159 12 11 Children1 3-6 0.02598 0.52183 0.54781 8 308 15 15 Children2 6-10 0.20487 0.52183 0.72670 8 39 15 11 Adolescents 10-14 0.10905 0.41467 0.52372 8 73 19 15 Adolescents 14-18 0.07720 0.39029 0.46749 8 104 20 17 Aggregated exposure not including body lotion Infants 0.5-1 0.06819 0.04420 0.11239 8 117 181 71 Toddler 1-3 0.05043 0.04160 0.09203 8 159 192 87 Children1 3-6 0.02598","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_047"} |
| Regulatory source |
- |
1 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=1; DOSE=From postnatal days (PNDs) 19 to 21, rats were treated daily with 17α-Ethinylestradiol (positive control;; EFFECT=4 hormone. But the rat is a rather sensitive model for chemical induced changes in thyroid hormones compared to humans, due to a lack of T4 binding protein which results in a shorter T4 serum half-life. It is important to acknowledge major differences in the thyroid hormone physiology and regulation between rats and humans. Ref.: Stoker 2010; SCCS 2011 Animal studies published after the previous SCCS opinion on triclosan from 2011 are summarized in Table A1 in Annex A. The most relevant studies for defining a new NOAEL for triclosan are described in more details below. Female reproduction Jung et al. (2012) used Sprague-Dawley rats for screening estrogenic activity of triclosan in the uteri of immature rats. From postnatal days (PNDs) 19 to 21, rats were treated daily with 17α-Ethinylestradiol (positive control; 1 mg/kg bw/day) and triclosan (7.5, 37.5, and 187.5 mg/kg bw/day) via oral gavage or with corn oil (5 ml/kg BW/day) as a vehicle control. Bodyweight, clinical signs, and abnormal behaviours were recorded daily throughou; CITATION=Ref.: Stoker 2010; CITATION_NUMBERS=[2010]; REFERENCE=Ref.: Stoker 2010; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Stoker 2010","dose":"From postnatal days (PNDs) 19 to 21, rats were treated daily with 17α-Ethinylestradiol (positive control;","duration":"","effect":"4 hormone. But the rat is a rather sensitive model for chemical induced changes in thyroid hormones compared to humans, due to a lack of T4 binding protein which results in a shorter T4 serum half-life. It is important to acknowledge major differences in the thyroid hormone physiology and regulation between rats and humans. Ref.: Stoker 2010; SCCS 2011 Animal studies published after the previous SCCS opinion on triclosan from 2011 are summarized in Table A1 in Annex A. The most relevant studies for defining a new NOAEL for triclosan are described in more details below. Female reproduction Jung et al. (2012) used Sprague-Dawley rats for screening estrogenic activity of triclosan in the uteri of immature rats. From postnatal days (PNDs) 19 to 21, rats were treated daily with 17α-Ethinylestradiol (positive control; 1 mg/kg bw/day) and triclosan (7.5, 37.5, and 187.5 mg/kg bw/day) via oral gavage or with corn oil (5 ml/kg BW/day) as a vehicle control. Bodyweight, clinical signs, and abnormal behaviours were recorded daily throughou","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1","page":26,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_023"} |
| Regulatory source |
- |
1.5 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=1.5; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 23 female offspring given 3.0 mg/kg bw/day of triclocarban when compared to the control. The NOAEL derived from this study was 1.5 mg/kg bw/day. Ref.: Costa 2020a In the Costa et al. (2020b) study, pregnant female Wistar rats were given 0, 0.3, 1.5 or 3.0 mg/kg bw/day of triclocarban (n = 8–11/group) daily by oral gavage from gestational day 0 to lactational day 21. The male pups (F1 generation) were weaned on PND 21 and included in the study. The study was based on OECD 421. On PND 21, three male pups from each litter were selected for different time point evaluations: infancy (PND 21), puberty (PND 50) and a; CITATION=Ref.: Costa 2020a In the Costa et al; CITATION_NUMBERS=[2020]; REFERENCE=Ref.: Costa 2020a In the Costa et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Costa 2020a In the Costa et al","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 23 female offspring given 3.0 mg/kg bw/day of triclocarban when compared to the control. The NOAEL derived from this study was 1.5 mg/kg bw/day. Ref.: Costa 2020a In the Costa et al. (2020b) study, pregnant female Wistar rats were given 0, 0.3, 1.5 or 3.0 mg/kg bw/day of triclocarban (n = 8–11/group) daily by oral gavage from gestational day 0 to lactational day 21. The male pups (F1 generation) were weaned on PND 21 and included in the study. The study was based on OECD 421. On PND 21, three male pups from each litter were selected for different time point evaluations: infancy (PND 21), puberty (PND 50) and a","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1.5","page":23,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_015"} |
| Regulatory source |
- |
2 |
- |
- |
dermal |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Table 2: Triclosan | SED dermal | NOAEL; EFFECT=Table 2: Triclosan | SED dermal | NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Triclosan | SED dermal | NOAEL","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Table 2: Triclosan | SED dermal | NOAEL","page":56,"route":"dermal","species":"","study_id":"sccs_o_265_noael_083"} |
| Regulatory source |
- |
=3 |
mg/kg bw/day |
mouse |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 3.0; DOSE=teroid dehydrogenase (3βHSD) at both doses, and AR-positive germ cells at the highest dose compared to the control.; EFFECT=teroid dehydrogenase (3βHSD) at both doses, and AR-positive germ cells at the highest dose compared to the control. The pups also had decreased mRNA levels for 3βHSD and OCT3/4 at both doses, and AR at the highest dose compared to the control. The daily sperm production was significantly reduced in both dose groups compared to the control (5% and 37% for low and high dose, respectively). According to the authors, germ cell maturation of the male pups and bodyweight were significantly influenced by the higher dose. NOAEL = 3.0 mg/kg bw/day. Ref.: Mandal 2020 Raj et al. (2021) studied the effects on the weights and histopathology of the epididymis and seminal vesicle, sperm indices (motility, viability, count and morphology), concentrations of epididymal sialic acid and seminal vesicular fructose. Swiss strain adult male mice were given 0, 40, 80, 160 of 320 mg/kg bw/day of triclosan orally on 42 consecutive days (n=12/group). Twenty-four hours after the last treatment, final body weights of the mice were recorded. Six animals fr; CITATION=Ref.: Mandal 2020 Raj et al; CITATION_NUMBERS=[2020]; REFERENCE=Ref.: Mandal 2020 Raj et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Mandal 2020 Raj et al","dose":"teroid dehydrogenase (3βHSD) at both doses, and AR-positive germ cells at the highest dose compared to the control.","duration":"","effect":"teroid dehydrogenase (3βHSD) at both doses, and AR-positive germ cells at the highest dose compared to the control. The pups also had decreased mRNA levels for 3βHSD and OCT3/4 at both doses, and AR at the highest dose compared to the control. The daily sperm production was significantly reduced in both dose groups compared to the control (5% and 37% for low and high dose, respectively). According to the authors, germ cell maturation of the male pups and bodyweight were significantly influenced by the higher dose. NOAEL = 3.0 mg/kg bw/day. Ref.: Mandal 2020 Raj et al. (2021) studied the effects on the weights and histopathology of the epididymis and seminal vesicle, sperm indices (motility, viability, count and morphology), concentrations of epididymal sialic acid and seminal vesicular fructose. Swiss strain adult male mice were given 0, 40, 80, 160 of 320 mg/kg bw/day of triclosan orally on 42 consecutive days (n=12/group). Twenty-four hours after the last treatment, final body weights of the mice were recorded. Six animals fr","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 3.0","page":28,"route":"","species":"mouse","study_id":"sccs_o_265_noael_027"} |
| Regulatory source |
- |
5 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=5; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________79 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Mandal et al. 2020 Male rats (Rattus norvegicus) Lactating mothers given oral doses from PND1-28 Doses: 3 and 5 mg/kg bw/day ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 NOAEL = 5 Raj et al. 2021 Male Swiss rats Adult rats given oral doses on 42 consecutive days Doses: 40, 80, 160 and 320 mg/kg bw/day N=12/group ↓ weight; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________79 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Mandal et al. 2020 Male rats (Rattus norvegicus) Lactating mothers given oral doses from PND1-28 Doses: 3 and 5 mg/kg bw/day ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 NOAEL = 5 Raj et al. 2021 Male Swiss rats Adult rats given oral doses on 42 consecutive days Doses: 40, 80, 160 and 320 mg/kg bw/day N=12/group ↓ weight","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":79,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_069"} |
| Regulatory source |
- |
5 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=5; DOSE=3 and 5 mg/kg bw/day | ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 | NOAEL = 5; EFFECT=Unlabeled table on page 79: Mandal et al. | 2020 | Male rats (Rattus norvegicus) | Lactating mothers given oral doses from PND1-28 Doses: 3 and 5 mg/kg bw/day | ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 | NOAEL = 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"3 and 5 mg/kg bw/day | ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 | NOAEL = 5","duration":"","effect":"Unlabeled table on page 79: Mandal et al. | 2020 | Male rats (Rattus norvegicus) | Lactating mothers given oral doses from PND1-28 Doses: 3 and 5 mg/kg bw/day | ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 | NOAEL = 5","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"5","page":79,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_183"} |
| Regulatory source |
- |
=6.75 |
mg/kg bw/d |
rat |
oral |
chronic |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 6.75; DOSE=The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5).; EFFECT=chronic dermal toxicity data, the results of an oral study have been used for the calculation of the Margin of Safety (MOS). The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5). To calculate a MOS for dermal exposure, a route-to-route extrapolation was made. The information on absorption after oral administration, i.e. 27%, was used to calculate an internal NOEL. This internal NOEL (25 x 0.27 = 6.75 mg/kg bw/d) is subsequently divided by the estimated dermal maximum systemic exposure dose, as presented in Table A2. The results of the MOS calculations for the individual as well as the aggregate exposure scenarios are presented in Table A3. Table A3: Calculated Margins of Safety for uses of Triclocarban in liquid and bar soaps and shower gels Product Adults Bar Soap Exposure 0.0074 mg/kg bw/d MOS 912 Liquid Soap Exposure 0.0195 mg/kg bw/d MOS 346 Body Wash Exposure 0.0052 mg/kg bw/d MOS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5).","duration":"chronic","effect":"chronic dermal toxicity data, the results of an oral study have been used for the calculation of the Margin of Safety (MOS). The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5). To calculate a MOS for dermal exposure, a route-to-route extrapolation was made. The information on absorption after oral administration, i.e. 27%, was used to calculate an internal NOEL. This internal NOEL (25 x 0.27 = 6.75 mg/kg bw/d) is subsequently divided by the estimated dermal maximum systemic exposure dose, as presented in Table A2. The results of the MOS calculations for the individual as well as the aggregate exposure scenarios are presented in Table A3. Table A3: Calculated Margins of Safety for uses of Triclocarban in liquid and bar soaps and shower gels Product Adults Bar Soap Exposure 0.0074 mg/kg bw/d MOS 912 Liquid Soap Exposure 0.0195 mg/kg bw/d MOS 346 Body Wash Exposure 0.0052 mg/kg bw/d MOS","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 6.75","page":33,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_017"} |
| Regulatory source |
- |
6.75 |
mg/kg bw/day |
rat |
oral |
2-year |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6.75; DOSE=ge (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467 0.52372 Adolescents 14-18 0.07720 0.39029 0.46749 3.6 SAFETY EVALUATION 3.6.1 SAFETY EVALUATION OF TRICLOCARBAN A NOAEL of 25 m...; EFFECT=ge (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467 0.52372 Adolescents 14-18 0.07720 0.39029 0.46749 3.6 SAFETY EVALUATION 3.6.1 SAFETY EVALUATION OF TRICLOCARBAN A NOAEL of 25 mg/kg bw/day was selected from a 2-year chronic feeding study in rats. The information on absorption after oral administration, i.e. 27%, was used to calculate an adjusted NOAEL of 6.75 mg/kg bw/day (25 mg/kg bw/day x 27% = 6.75 mg/kg bw/day). 3.6.1.1 Safety evaluation of triclocarban in adults MoS calculations for the use of triclocarban as an ingredient in the rinse-off products and as a preservative for adults are shown in Table 18 and Table 19, respectively. Table 18. MoS calculations for triclocarban when used as an ingredient in rinse-off products The Margin of Safety (MoS) for exposure to triclocarban used in rinse-off products (1.5%) is above 100 for each individual product; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"ge (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467 0.52372 Adolescents 14-18 0.07720 0.39029 0.46749 3.6 SAFETY EVALUATION 3.6.1 SAFETY EVALUATION OF TRICLOCARBAN A NOAEL of 25 m...","duration":"2-year","effect":"ge (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467 0.52372 Adolescents 14-18 0.07720 0.39029 0.46749 3.6 SAFETY EVALUATION 3.6.1 SAFETY EVALUATION OF TRICLOCARBAN A NOAEL of 25 mg/kg bw/day was selected from a 2-year chronic feeding study in rats. The information on absorption after oral administration, i.e. 27%, was used to calculate an adjusted NOAEL of 6.75 mg/kg bw/day (25 mg/kg bw/day x 27% = 6.75 mg/kg bw/day). 3.6.1.1 Safety evaluation of triclocarban in adults MoS calculations for the use of triclocarban as an ingredient in the rinse-off products and as a preservative for adults are shown in Table 18 and Table 19, respectively. Table 18. MoS calculations for triclocarban when used as an ingredient in rinse-off products The Margin of Safety (MoS) for exposure to triclocarban used in rinse-off products (1.5%) is above 100 for each individual product","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"6.75","page":48,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_039"} |
| Regulatory source |
- |
8 |
mg/kg |
rat |
oral |
2-year |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=se a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats.; EFFECT=se a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats. The human studies do not provide robust evidence of endocrine disruptive effects of triclocarban. 3.4.3.5 Endocrine activity of triclosan: In vivo animal data (Level 3) Animal studies published after the previous SCCS Opinion on triclosan from 2011 are summarised in Table A1 in Annex A. The most relevant studies for defining a new NOAEL for triclosan are described in more detail below. Female reproduction The (anti)estrogenicity of triclosan was evaluated in the uterotrophic assay (EPA’s OPPTS 890.1600 guideline) in 18-day old female Wistar rats (Montagnini et al. 2018). For three consecutive days from PND18-20, female rats were administered by gavage corn oil (negative control), estradiol valerate (positive control) or 0.8, 2.4 or 8 mg/kg of triclosan (n=6-7). For evaluation of the possible anti-estrogenicity of triclosan, the rats were given e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"se a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats.","duration":"2-year","effect":"se a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats. The human studies do not provide robust evidence of endocrine disruptive effects of triclocarban. 3.4.3.5 Endocrine activity of triclosan: In vivo animal data (Level 3) Animal studies published after the previous SCCS Opinion on triclosan from 2011 are summarised in Table A1 in Annex A. The most relevant studies for defining a new NOAEL for triclosan are described in more detail below. Female reproduction The (anti)estrogenicity of triclosan was evaluated in the uterotrophic assay (EPA’s OPPTS 890.1600 guideline) in 18-day old female Wistar rats (Montagnini et al. 2018). For three consecutive days from PND18-20, female rats were administered by gavage corn oil (negative control), estradiol valerate (positive control) or 0.8, 2.4 or 8 mg/kg of triclosan (n=6-7). For evaluation of the possible anti-estrogenicity of triclosan, the rats were given e","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8","page":25,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_019"} |
| Regulatory source |
- |
=8 |
mg/kg bw/day |
rat |
oral |
3-day |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 8; DOSE=or 0.8, 2.4 or 8 mg/kg of triclosan (n=6-7).; EFFECT=or 0.8, 2.4 or 8 mg/kg of triclosan (n=6-7). For evaluation of the possible anti-estrogenicity of triclosan, the rats were given estradiol (negative control), estradiol valerate + tamoxifen citrate, estradiol valerate + 0.0, 2.4 or 8 mg/kg triclosan (n=6-7). After 24 hours of the final dose, the rats were examined for vaginal opening and weighed. Uterus was weighed. During the 3-day treatment period, general clinical observation was conducted. Triclosan had no effect on the uterus weight in the uterotrophic assay. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2018 Male reproduction The (anti)androgenicity of triclosan was evaluated in the Hershberger assay (EPA’s OPPTS 890.1400 guideline) in 52-day old male Wistar rats (Pernoncini et al. 2018). The triclosan dosages were based on the acceptable daily intake, in addition to 3 and 10-fold higher doses. Castrated males were administered by gavage corn oil (negative control), testosterone propionate (positive control) or 0.8, 2.4 or 8 mg/kg of triclosan (n=6). For evaluation of anti- and; CITATION=Ref.: Montagnini 2018 Male reproduction The (anti)androgenicity of triclosan was evaluated in the Hershberger assay (EPA’s OPPTS 890; CITATION_NUMBERS=[2018,890]; REFERENCE=Ref.: Montagnini 2018 Male reproduction The (anti)androgenicity of triclosan was evaluated in the Hershberger assay (EPA’s OPPTS 890; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Montagnini 2018 Male reproduction The (anti)androgenicity of triclosan was evaluated in the Hershberger assay (EPA’s OPPTS 890","dose":"or 0.8, 2.4 or 8 mg/kg of triclosan (n=6-7).","duration":"3-day","effect":"or 0.8, 2.4 or 8 mg/kg of triclosan (n=6-7). For evaluation of the possible anti-estrogenicity of triclosan, the rats were given estradiol (negative control), estradiol valerate + tamoxifen citrate, estradiol valerate + 0.0, 2.4 or 8 mg/kg triclosan (n=6-7). After 24 hours of the final dose, the rats were examined for vaginal opening and weighed. Uterus was weighed. During the 3-day treatment period, general clinical observation was conducted. Triclosan had no effect on the uterus weight in the uterotrophic assay. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2018 Male reproduction The (anti)androgenicity of triclosan was evaluated in the Hershberger assay (EPA’s OPPTS 890.1400 guideline) in 52-day old male Wistar rats (Pernoncini et al. 2018). The triclosan dosages were based on the acceptable daily intake, in addition to 3 and 10-fold higher doses. Castrated males were administered by gavage corn oil (negative control), testosterone propionate (positive control) or 0.8, 2.4 or 8 mg/kg of triclosan (n=6). For evaluation of anti- and","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 8","page":25,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_020"} |
| Regulatory source |
- |
=8 |
mg/kg bw/day |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 8; DOSE=NOAEL = 8 mg/kg bw/day.; EFFECT=643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 26 groups compared to the vehicle group. The results demonstrated that triclosan did not act as an endocrine disrupter, with no (anti)androgenic effect in the Hershberger assay. NOAEL = 8 mg/kg bw/day. Ref.: Pernoncini 2018 3.4.3.6 Endocrine activity of triclosan: In vivo animal data (Level 4) From SCCS/1414/11 Several studies show that triclosan can affect thyroid hormone homeostasis in the rat. The effective doses vary between studies, which are probably related to differences in exposure duration as well as sex, age and strain of rats. Overall, a NOEL of 9.4 mg/kg bw/day, and a LOEL of 18.75 mg/kg bw/day for decreases in total serum T4 (Stoker et al., 2010) can be considered as valid estima; CITATION=Ref.: Pernoncini 2018 3; CITATION_NUMBERS=[2018,3]; REFERENCE=Ref.: Pernoncini 2018 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Pernoncini 2018 3","dose":"NOAEL = 8 mg/kg bw/day.","duration":"","effect":"643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 26 groups compared to the vehicle group. The results demonstrated that triclosan did not act as an endocrine disrupter, with no (anti)androgenic effect in the Hershberger assay. NOAEL = 8 mg/kg bw/day. Ref.: Pernoncini 2018 3.4.3.6 Endocrine activity of triclosan: In vivo animal data (Level 4) From SCCS/1414/11 Several studies show that triclosan can affect thyroid hormone homeostasis in the rat. The effective doses vary between studies, which are probably related to differences in exposure duration as well as sex, age and strain of rats. Overall, a NOEL of 9.4 mg/kg bw/day, and a LOEL of 18.75 mg/kg bw/day for decreases in total serum T4 (Stoker et al., 2010) can be considered as valid estima","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 8","page":26,"route":"","species":"rat","study_id":"sccs_o_265_noael_021"} |
| Regulatory source |
- |
=8 |
mg/kg bw/day |
rat |
oral |
8 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 8; DOSE=NOAEL = 8 mg/kg bw/day.; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=g bw/day). No statistical differences were observed in the sperm count parameters. No changes in testicular histomorphometry were observed in F1 (testicular volume, interstitial content volume, seminiferous tubules volume, diameter of seminiferous tubules, and total length of seminiferous tubules). Triclosan did not affect sexual development in F1 and F2 generations (number of pups, sex ration, relative AGD, nipple retention). Further, no effects were seen for physical and neuromotor development or motor activity. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day). The following studies support the selection of a new PoD for triclosan: • 10 mg/kg bw/day: decrease in daily sperm production after 8 weeks of oral exposure of Sprague-Dawley rats (Lan et al., 2015) (LOAEL: 50 mg/kg bw/day) • 8 mg/kg bw/day: no effects on uterus weight, estrous cyclic endpoints in F0 or F1 at the highest do; CITATION=Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day); CITATION_NUMBERS=[2021,3,5,2009,12,40]; REFERENCE=Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day); DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day)","dose":"NOAEL = 8 mg/kg bw/day.","duration":"8 weeks","effect":"g bw/day). No statistical differences were observed in the sperm count parameters. No changes in testicular histomorphometry were observed in F1 (testicular volume, interstitial content volume, seminiferous tubules volume, diameter of seminiferous tubules, and total length of seminiferous tubules). Triclosan did not affect sexual development in F1 and F2 generations (number of pups, sex ration, relative AGD, nipple retention). Further, no effects were seen for physical and neuromotor development or motor activity. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day). The following studies support the selection of a new PoD for triclosan: • 10 mg/kg bw/day: decrease in daily sperm production after 8 weeks of oral exposure of Sprague-Dawley rats (Lan et al., 2015) (LOAEL: 50 mg/kg bw/day) • 8 mg/kg bw/day: no effects on uterus weight, estrous cyclic endpoints in F0 or F1 at the highest do","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"= 8","page":30,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_030"} |
| Regulatory source |
- |
8 |
mg/kg bw/day |
- |
oral |
10 years |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al.; EFFECT=_____________________________________ ___________________________________________________________________________________________ 55 Table 24. MoS calculations for triclocarban by age categories when used as a preservative (0.2%) and in rinse off products (1.5%), mouthwash use excluded. * Without mouth wash Aggregated exposure to triclocarban used as a preservative (0.2%) and in rinse–off products (1.5%) result in a MoS below 100 for children below the age of 10 years. 3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al. (2018, 2020) and Pernoncini et al. (2018) is used for the calculation of MoS. An oral availability of 100% was assumed, and thus no adjustments to the NOAEL were performed. 3.6.2.1 Safety evaluation of triclosan in adult MoS calculations for separate product types and aggregated exposures are shown in Table 24. Since body lotions contribute significantly to the SED for aggregated exposures, MoS for aggregated exposures not incl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al.","duration":"10 years","effect":"_____________________________________ ___________________________________________________________________________________________ 55 Table 24. MoS calculations for triclocarban by age categories when used as a preservative (0.2%) and in rinse off products (1.5%), mouthwash use excluded. * Without mouth wash Aggregated exposure to triclocarban used as a preservative (0.2%) and in rinse–off products (1.5%) result in a MoS below 100 for children below the age of 10 years. 3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al. (2018, 2020) and Pernoncini et al. (2018) is used for the calculation of MoS. An oral availability of 100% was assumed, and thus no adjustments to the NOAEL were performed. 3.6.2.1 Safety evaluation of triclosan in adult MoS calculations for separate product types and aggregated exposures are shown in Table 24. Since body lotions contribute significantly to the SED for aggregated exposures, MoS for aggregated exposures not incl","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"8","page":55,"route":"oral","species":"","study_id":"sccs_o_265_noael_040"} |
| Regulatory source |
- |
8 |
mg/kg bw/d |
rat |
oral |
8-months |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; LOAEL_VALUE=8 mg/kg bw/d; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________73 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Hua et al. 2017 ICR mice Gestational and non-gestational female mice Exposure from GD5-GD17 Doses: 1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 NOAEL =1 Louis et al. 2017 Female Wistar rats 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"8-months","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________73 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Hua et al. 2017 ICR mice Gestational and non-gestational female mice Exposure from GD5-GD17 Doses: 1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 NOAEL =1 Louis et al. 2017 Female Wistar rats 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"8 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"8","page":73,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_057"} |
| Regulatory source |
- |
8 |
mg/kg |
rat |
- |
10 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; LOAEL_VALUE=8 mg/kg; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________76 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) miR-6321 in testis at 100-200 Montagnini et al. 2018 Female, Wistar rats Uterotrophic assay 0.8, 2.4 and 8 mg/kg n = 6-7 0.3 mg/kg estradiol valerate as positive control For anti-estrogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weigh; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"10 weeks","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________76 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) miR-6321 in testis at 100-200 Montagnini et al. 2018 Female, Wistar rats Uterotrophic assay 0.8, 2.4 and 8 mg/kg n = 6-7 0.3 mg/kg estradiol valerate as positive control For anti-estrogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weigh","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"8 mg/kg","noael_unit":"mg/kg","noael_value":"8","page":76,"route":"","species":"rat","study_id":"sccs_o_265_noael_064"} |
| Regulatory source |
- |
8 |
mg/kg |
rat |
- |
10 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________8...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________80 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Montagnini et al. 2021 Male Wistar rats Two-generation reproduction study (based on OECD 416 and 426) 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention NOAEL = 8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dos; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________8...","duration":"10 weeks","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________80 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Montagnini et al. 2021 Male Wistar rats Two-generation reproduction study (based on OECD 416 and 426) 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention NOAEL = 8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dos","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8","page":80,"route":"","species":"rat","study_id":"sccs_o_265_noael_071"} |
| Regulatory source |
- |
8 |
mg/kg |
rat |
- |
10 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=____________________________________________________80 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Montagnini et al.; EFFECT=____________________________________________________80 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Montagnini et al. 2021 Male Wistar rats Two-generation reproduction study (based on OECD 416 and 426) 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention NOAEL = 8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"____________________________________________________80 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Montagnini et al.","duration":"10 weeks","effect":"____________________________________________________80 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Montagnini et al. 2021 Male Wistar rats Two-generation reproduction study (based on OECD 416 and 426) 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention NOAEL = 8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8","page":80,"route":"","species":"rat","study_id":"sccs_o_265_noael_072"} |
| Regulatory source |
- |
8 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.; EFFECT=8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:8 ADI: Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.","page":80,"route":"","species":"human","study_id":"sccs_o_265_noael_073"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Infa | nts | 0.5-1 | 0.3 | 0.06819 | 8 | 117; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Infa | nts | 0.5-1 | 0.3 | 0.06819 | 8 | 117","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_084"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Tod | dler | 1-3 | 0.3 | 0.05043 | 8 | 159; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Tod | dler | 1-3 | 0.3 | 0.05043 | 8 | 159","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_085"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Chil | dren | 3-6 | 0.3 | 0.02598 | 8 | 308; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Chil | dren | 3-6 | 0.3 | 0.02598 | 8 | 308","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_086"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Chil | dren | 6-10 | 0.3 | 0.01785 | 8 | 448; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Chil | dren | 6-10 | 0.3 | 0.01785 | 8 | 448","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_087"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Ado | lescents | 0.3 | 0.00951 | 8 | 841; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Ado | lescents | 0.3 | 0.00951 | 8 | 841","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_088"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Ado | lescents | 0.3 | 0.00672 | 8 | 1 | 190; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Ado | lescents | 0.3 | 0.00672 | 8 | 1 | 190","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_089"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Chil | dren | 6-10 | 0.2 | 0.18702 | 8 | 43; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Chil | dren | 6-10 | 0.2 | 0.18702 | 8 | 43","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_090"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Ado | lescents | 0.2 | 0.09954 | 8 | 80; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Ado | lescents | 0.2 | 0.09954 | 8 | 80","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_091"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Ado | lescents | 0.2 | 0.07048 | 8 | 114; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Ado | lescents | 0.2 | 0.07048 | 8 | 114","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_092"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Chil | dren1 | 3-6 | 0.3 | 0.02598 | 8 | 308; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Chil | dren1 | 3-6 | 0.3 | 0.02598 | 8 | 308","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_093"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Chil | dren2 | 6-10 | 0.3/0.2 | 0.20487 | 8 | 39; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Chil | dren2 | 6-10 | 0.3/0.2 | 0.20487 | 8 | 39","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_094"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Ado | lescents | 0.3/0.2 | 0.10905 | 8 | 73; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Ado | lescents | 0.3/0.2 | 0.10905 | 8 | 73","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_095"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 2: Ado | lescents | 0.3/0.2 | 0.07720 | 8 | 104; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 2: Ado | lescents | 0.3/0.2 | 0.07720 | 8 | 104","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"","species":"","study_id":"sccs_o_265_noael_096"} |
| Regulatory source |
- |
8 |
- |
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oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Infants | 0.5-1 | 0.3 | 0.06819 | 8 | 117; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Infants | 0.5-1 | 0.3 | 0.06819 | 8 | 117","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_098"} |
| Regulatory source |
- |
8 |
- |
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oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Toddler | 1-3 | 0.3 | 0.05043 | 8 | 159; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Toddler | 1-3 | 0.3 | 0.05043 | 8 | 159","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_099"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Children | 3-6 | 0.3 | 0.02598 | 8 | 308; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Children | 3-6 | 0.3 | 0.02598 | 8 | 308","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_100"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Children | 6-10 | 0.3 | 0.01785 | 8 | 448; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Children | 6-10 | 0.3 | 0.01785 | 8 | 448","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_101"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 10- 14 | 0.3 | 0.00951 | 8 | 841; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 10- 14 | 0.3 | 0.00951 | 8 | 841","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_102"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 14- 18 | 0.3 | 0.00672 | 8 | 1 190; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 14- 18 | 0.3 | 0.00672 | 8 | 1 190","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_103"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Children | 6-10 | 0.2 | 0.18702 | 8 | 43; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Children | 6-10 | 0.2 | 0.18702 | 8 | 43","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_104"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 10- 14 | 0.2 | 0.09954 | 8 | 80; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 10- 14 | 0.2 | 0.09954 | 8 | 80","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_105"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 14- 18 | 0.2 | 0.07048 | 8 | 114; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 14- 18 | 0.2 | 0.07048 | 8 | 114","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_106"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Children1 | 3-6 | 0.3 | 0.02598 | 8 | 308; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Children1 | 3-6 | 0.3 | 0.02598 | 8 | 308","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_107"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Children2 | 6-10 | 0.3/0.2 | 0.20487 | 8 | 39; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Children2 | 6-10 | 0.3/0.2 | 0.20487 | 8 | 39","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_108"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 10- 14 | 0.3/0.2 | 0.10905 | 8 | 73; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 10- 14 | 0.3/0.2 | 0.10905 | 8 | 73","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_109"} |
| Regulatory source |
- |
8 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 14- 18 | 0.3/0.2 | 0.07720 | 8 | 104; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Adolescents | 14- 18 | 0.3/0.2 | 0.07720 | 8 | 104","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_110"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Children | 3-10 | 0.3 | 0.00392 | 8 | 2 041; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Children | 3-10 | 0.3 | 0.00392 | 8 | 2 041","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_112"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 10-14 | 0.3 | 0.00312 | 8 | 2 564; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 10-14 | 0.3 | 0.00312 | 8 | 2 564","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_113"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00288 | 8 | 2 778; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00288 | 8 | 2 778","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_114"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Infants | 0.5-1 | 0.3 | 0.64255 | 8 | 12; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Infants | 0.5-1 | 0.3 | 0.64255 | 8 | 12","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_115"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Toddler | 1-3 | 0.3 | 0.60545 | 8 | 13; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Toddler | 1-3 | 0.3 | 0.60545 | 8 | 13","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_116"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Children | 3-10 | 0.3 | 0.48462 | 8 | 17; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Children | 3-10 | 0.3 | 0.48462 | 8 | 17","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_117"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 10-14 | 0.3 | 0.38508 | 8 | 21; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 10-14 | 0.3 | 0.38508 | 8 | 21","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_118"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.35669 | 8 | 22; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.35669 | 8 | 22","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_119"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00564 | 8 | 1 418; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00564 | 8 | 1 418","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_120"} |
| Regulatory source |
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8 |
- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00057 | 8 | 14 035; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00057 | 8 | 14 035","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_121"} |
| Regulatory source |
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8 |
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- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Children | 3-10 | 0.3 | 0.48854 | 8 | 16; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Children | 3-10 | 0.3 | 0.48854 | 8 | 16","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_122"} |
| Regulatory source |
- |
8 |
- |
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- |
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- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 10-14 | 0.3 | 0.38820 | 8 | 21; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 10-14 | 0.3 | 0.38820 | 8 | 21","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_123"} |
| Regulatory source |
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8 |
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- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.36578 | 8 | 22; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.36578 | 8 | 22","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_124"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Infants | 0.5-1 | 0.3 | - | 8 | -; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Infants | 0.5-1 | 0.3 | - | 8 | -","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_125"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Toddler | 1-3 | 0.3 | - | 8 | -; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Toddler | 1-3 | 0.3 | - | 8 | -","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_126"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00909 | 8 | 880; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Adolescents | 14-18 | 0.3 | 0.00909 | 8 | 880","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_127"} |
| Regulatory source |
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8 |
- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Infants | 0.5- | 1 | 0.03 | 0.03289 | 8 | 24 | 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Infants | 0.5- | 1 | 0.03 | 0.03289 | 8 | 24 | 3","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_129"} |
| Regulatory source |
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8 |
- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Toddler | 1-3 | 0.03 | 0.03096 | 8 | 25 | 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Toddler | 1-3 | 0.03 | 0.03096 | 8 | 25 | 8","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_130"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Children | 3-1 | 0 | 0.03 | 0.02477 | 8 | 32 | 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Children | 3-1 | 0 | 0.03 | 0.02477 | 8 | 32 | 3","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_131"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 10-1 | 4 | 0.03 | 0.01970 | 8 | 40 | 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 10-1 | 4 | 0.03 | 0.01970 | 8 | 40 | 6","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_132"} |
| Regulatory source |
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8 |
- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 14-1 | 8 | 0.03 | 0.01824 | 8 | 43 | 9; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 14-1 | 8 | 0.03 | 0.01824 | 8 | 43 | 9","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_133"} |
| Regulatory source |
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8 |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Infants | 0.5- | 1 | 0.03 | 0.01131 | 8 | 70 | 7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Infants | 0.5- | 1 | 0.03 | 0.01131 | 8 | 70 | 7","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_134"} |
| Regulatory source |
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8 |
- |
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- |
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- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Toddler | 1-3 | 0.03 | 0.01064 | 8 | 75 | 2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Toddler | 1-3 | 0.03 | 0.01064 | 8 | 75 | 2","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_135"} |
| Regulatory source |
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8 |
- |
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- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Children | 3-1 | 0 | 0.03 | 0.00852 | 8 | 93 | 9; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Children | 3-1 | 0 | 0.03 | 0.00852 | 8 | 93 | 9","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_136"} |
| Regulatory source |
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8 |
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- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 10-1 | 4 | 0.03 | 0.00677 | 8 | 1 | 18 | 2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 10-1 | 4 | 0.03 | 0.00677 | 8 | 1 | 18 | 2","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_137"} |
| Regulatory source |
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8 |
- |
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- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 14-1 | 8 | 0.03 | 0.00627 | 8 | 1 | 27 | 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 14-1 | 8 | 0.03 | 0.00627 | 8 | 1 | 27 | 6","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_138"} |
| Regulatory source |
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8 |
- |
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- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Infants | 0.5- | 1 | 0.03 | 0.0442 | 0 | 8 | 18 | 1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Infants | 0.5- | 1 | 0.03 | 0.0442 | 0 | 8 | 18 | 1","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_139"} |
| Regulatory source |
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8 |
- |
- |
- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Toddler | 1-3 | 0.03 | 0.0416 | 0 | 8 | 19 | 2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Toddler | 1-3 | 0.03 | 0.0416 | 0 | 8 | 19 | 2","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_140"} |
| Regulatory source |
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8 |
- |
- |
- |
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SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Children | 3-1 | 0 | 0.03 | 0.03329 | 8 | 24 | 0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Children | 3-1 | 0 | 0.03 | 0.03329 | 8 | 24 | 0","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_141"} |
| Regulatory source |
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8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 10-1 | 4 | 0.03 | 0.02647 | 8 | 30 | 2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 10-1 | 4 | 0.03 | 0.02647 | 8 | 30 | 2","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_142"} |
| Regulatory source |
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8 |
- |
- |
- |
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- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 14-1 | 8 | 0.03 | 0.02451 | 8 | 32 | 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Adolescent | s | 14-1 | 8 | 0.03 | 0.02451 | 8 | 32 | 6","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_143"} |
| Regulatory source |
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8 |
- |
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- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Infants | 0.5-1 | 0.06819 | 0.68675 | 0.75494 | 8 | 117 | 12 | 11; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Infants | 0.5-1 | 0.06819 | 0.68675 | 0.75494 | 8 | 117 | 12 | 11","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_145"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Toddler | 1-3 | 0.05043 | 0.64705 | 0.69748 | 8 | 159 | 12 | 11; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Toddler | 1-3 | 0.05043 | 0.64705 | 0.69748 | 8 | 159 | 12 | 11","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_146"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children1 | 3-6 | 0.02598 | 0.52183 | 0.54781 | 8 | 308 | 15 | 15; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children1 | 3-6 | 0.02598 | 0.52183 | 0.54781 | 8 | 308 | 15 | 15","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_147"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children2 | 6-10 | 0.20487 | 0.52183 | 0.72670 | 8 | 39 | 15 | 11; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children2 | 6-10 | 0.20487 | 0.52183 | 0.72670 | 8 | 39 | 15 | 11","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_148"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 10-14 | 0.10905 | 0.41467 | 0.52372 | 8 | 73 | 19 | 15; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 10-14 | 0.10905 | 0.41467 | 0.52372 | 8 | 73 | 19 | 15","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_149"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 14-18 | 0.07720 | 0.39029 | 0.46749 | 8 | 104 | 20 | 17; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 14-18 | 0.07720 | 0.39029 | 0.46749 | 8 | 104 | 20 | 17","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_150"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Infants | 0.5-1 | 0.06819 | 0.04420 | 0.11239 | 8 | 117 | 181 | 71; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Infants | 0.5-1 | 0.06819 | 0.04420 | 0.11239 | 8 | 117 | 181 | 71","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_151"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Toddler | 1-3 | 0.05043 | 0.04160 | 0.09203 | 8 | 159 | 192 | 87; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Toddler | 1-3 | 0.05043 | 0.04160 | 0.09203 | 8 | 159 | 192 | 87","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_152"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children1 | 3-6 | 0.02598 | 0.03721 | 0.06319 | 8 | 308 | 215 | 127; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children1 | 3-6 | 0.02598 | 0.03721 | 0.06319 | 8 | 308 | 215 | 127","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_153"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children2 | 6-10 | 0.20487 | 0.03721 | 0.24208 | 8 | 39 | 215 | 33; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Children2 | 6-10 | 0.20487 | 0.03721 | 0.24208 | 8 | 39 | 215 | 33","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_154"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 10-14 | 0.10905 | 0.02959 | 0.13864 | 8 | 73 | 270 | 58; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 10-14 | 0.10905 | 0.02959 | 0.13864 | 8 | 73 | 270 | 58","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_155"} |
| Regulatory source |
- |
8 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 14-18 | 0.07720 | 0.03360 | 0.11080 | 8 | 104 | 238 | 72; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Adolescents | 14-18 | 0.07720 | 0.03360 | 0.11080 | 8 | 104 | 238 | 72","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"8","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_156"} |
| Regulatory source |
- |
8 |
mg/kg bw/d |
mouse |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 | Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 | NOAEL =1; EFFECT=Unlabeled table on page 73: Hua et al. | 2017 | ICR mice | Gestational and non-gestational female mice Exposure from GD5-GD17 Doses: 1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 | Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 | NOAEL =1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 | Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 | NOAEL =1","duration":"","effect":"Unlabeled table on page 73: Hua et al. | 2017 | ICR mice | Gestational and non-gestational female mice Exposure from GD5-GD17 Doses: 1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 | Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 | NOAEL =1","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"8","page":73,"route":"","species":"mouse","study_id":"sccs_o_265_noael_167"} |
| Regulatory source |
- |
8 |
mg/kg |
rat |
- |
10 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=Montagnini et al. | 2018 | Female, Wistar rats | Uterotrophic assay 0.8, 2.4 and 8 mg/kg n = 6-7 0.3 mg/kg estradiol valerate as positive control For anti-estrogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses:; EFFECT=Unlabeled table on page 76: Montagnini et al. | 2018 | Female, Wistar rats | Uterotrophic assay 0.8, 2.4 and 8 mg/kg n = 6-7 0.3 mg/kg estradiol valerate as positive control For anti-estrogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 | Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weights in F0 or F1 females: uterus, ovary, liver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ growing follicle number in F1 at 2.4 | NOAEL = 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Montagnini et al. | 2018 | Female, Wistar rats | Uterotrophic assay 0.8, 2.4 and 8 mg/kg n = 6-7 0.3 mg/kg estradiol valerate as positive control For anti-estrogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses:","duration":"10 weeks","effect":"Unlabeled table on page 76: Montagnini et al. | 2018 | Female, Wistar rats | Uterotrophic assay 0.8, 2.4 and 8 mg/kg n = 6-7 0.3 mg/kg estradiol valerate as positive control For anti-estrogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 | Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weights in F0 or F1 females: uterus, ovary, liver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ growing follicle number in F1 at 2.4 | NOAEL = 8","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8","page":76,"route":"","species":"rat","study_id":"sccs_o_265_noael_176"} |
| Regulatory source |
- |
8 |
mg/kg |
rat |
- |
10 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 | F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention | NOAEL = 8; EFFECT=Unlabeled table on page 80: Montagnini et al. | 2021 | Male Wistar rats | Two-generation reproduction study (based on OECD 416 and 426) 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 | F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention | NOAEL = 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 | F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention | NOAEL = 8","duration":"10 weeks","effect":"Unlabeled table on page 80: Montagnini et al. | 2021 | Male Wistar rats | Two-generation reproduction study (based on OECD 416 and 426) 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 8-10 | F1: ↔ AGD, organ weights, plasma testosterone ↓ sperm viability (percentage of live sperm or mobile sperm) at 2.4 ↔ sperm count parameters ↔ testicular histomorphometry F2: ↔ AGD, nipple retention | NOAEL = 8","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8","page":80,"route":"","species":"rat","study_id":"sccs_o_265_noael_186"} |
| Regulatory source |
- |
9.4 |
mg/kg bw/day |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=9.4; DOSE=NOAEL = 8 mg/kg bw/day.; EFFECT=up. The results demonstrated that triclosan did not act as an endocrine disrupter, with no (anti)androgenic effect in the Hershberger assay. NOAEL = 8 mg/kg bw/day. Ref.: Pernoncini 2018 3.4.3.6 Endocrine activity of triclosan: In vivo animal data (Level 4) From SCCS/1414/11 Several studies show that triclosan can affect thyroid hormone homeostasis in the rat. The effective doses vary between studies, which are probably related to differences in exposure duration as well as sex, age and strain of rats. Overall, a NOEL of 9.4 mg/kg bw/day, and a LOEL of 18.75 mg/kg bw/day for decreases in total serum T4 (Stoker et al., 2010) can be considered as valid estimates. The likely mode of action for this effect is increased clearance of T4 hormone. But the rat is a rather sensitive model for chemical induced changes in thyroid hormones compared to humans, due to a lack of T4 binding protein which results in a shorter T4 serum half-life. It is important to acknowledge major differences in the thyroid hormone physiology and regulation bet; CITATION=Ref.: Pernoncini 2018 3; CITATION_NUMBERS=[2018,3]; REFERENCE=Ref.: Pernoncini 2018 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Pernoncini 2018 3","dose":"NOAEL = 8 mg/kg bw/day.","duration":"","effect":"up. The results demonstrated that triclosan did not act as an endocrine disrupter, with no (anti)androgenic effect in the Hershberger assay. NOAEL = 8 mg/kg bw/day. Ref.: Pernoncini 2018 3.4.3.6 Endocrine activity of triclosan: In vivo animal data (Level 4) From SCCS/1414/11 Several studies show that triclosan can affect thyroid hormone homeostasis in the rat. The effective doses vary between studies, which are probably related to differences in exposure duration as well as sex, age and strain of rats. Overall, a NOEL of 9.4 mg/kg bw/day, and a LOEL of 18.75 mg/kg bw/day for decreases in total serum T4 (Stoker et al., 2010) can be considered as valid estimates. The likely mode of action for this effect is increased clearance of T4 hormone. But the rat is a rather sensitive model for chemical induced changes in thyroid hormones compared to humans, due to a lack of T4 binding protein which results in a shorter T4 serum half-life. It is important to acknowledge major differences in the thyroid hormone physiology and regulation bet","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"9.4","page":26,"route":"","species":"rat","study_id":"sccs_o_265_noael_022"} |
| Regulatory source |
- |
=10 |
mg/kg bw/day |
rat |
oral |
28 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 10; DOSE=the group treated with a high dose (200 mg/kg) compared with the control.; LOAEL_VALUE=50 mg/kg bw/day; EFFECT=the group treated with a high dose (200 mg/kg) compared with the control. Minor damage was observed in the cauda epididymis and the testis at the high dose of triclosan. The daily sperm production significantly decreased by 19.6% and 46.4% in the groups treated with 50 and 200 mg/kg triclosan compared to the control. Compared to the number of sperm in the control group, the groups treated with 50 mg/ kg and 200 mg/kg triclosan both showed elevated ratios of abnormal sperm heads and ratios of abnormal sperm tails. NOAEL = 10 mg/kg bw/day. LOAEL = 50 mg/kg bw/day. Ref.: Lan 2013 Lactating mother rats (Rattus norvegicus) were given oral daily doses of 0, 3, and 5 mg/kg bw/day of triclosan from the day of delivery until 28 days, equivalent to their natural breastfeeding duration. At 28 days, the male pups of all three groups were sacrificed and their biochemical parameters evaluated. Testicular sperm content and daily sperm production (DSP)/g testis analysis, histopathological analysis of the testes, and gene expression analysis we; CITATION=Ref.: Lan 2013 Lactating mother rats (Rattus norvegicus) were given oral daily doses of 0, 3, and 5 mg/kg bw/day of triclosan from the day of delivery until 28 days, equivalent to their; CITATION_NUMBERS=[2013,3,5,28]; REFERENCE=Ref.: Lan 2013 Lactating mother rats (Rattus norvegicus) were given oral daily doses of 0, 3, and 5 mg/kg bw/day of triclosan from the day of delivery until 28 days, equivalent to their; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Lan 2013 Lactating mother rats (Rattus norvegicus) were given oral daily doses of 0, 3, and 5 mg/kg bw/day of triclosan from the day of delivery until 28 days, equivalent to their","dose":"the group treated with a high dose (200 mg/kg) compared with the control.","duration":"28 days","effect":"the group treated with a high dose (200 mg/kg) compared with the control. Minor damage was observed in the cauda epididymis and the testis at the high dose of triclosan. The daily sperm production significantly decreased by 19.6% and 46.4% in the groups treated with 50 and 200 mg/kg triclosan compared to the control. Compared to the number of sperm in the control group, the groups treated with 50 mg/ kg and 200 mg/kg triclosan both showed elevated ratios of abnormal sperm heads and ratios of abnormal sperm tails. NOAEL = 10 mg/kg bw/day. LOAEL = 50 mg/kg bw/day. Ref.: Lan 2013 Lactating mother rats (Rattus norvegicus) were given oral daily doses of 0, 3, and 5 mg/kg bw/day of triclosan from the day of delivery until 28 days, equivalent to their natural breastfeeding duration. At 28 days, the male pups of all three groups were sacrificed and their biochemical parameters evaluated. Testicular sperm content and daily sperm production (DSP)/g testis analysis, histopathological analysis of the testes, and gene expression analysis we","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"50 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"= 10","page":28,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_026"} |
| Regulatory source |
- |
12 |
mg/kg bw/day |
rat |
oral |
8 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=12; DOSE=NOAEL = 8 mg/kg bw/day.; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=e observed in F1 (testicular volume, interstitial content volume, seminiferous tubules volume, diameter of seminiferous tubules, and total length of seminiferous tubules). Triclosan did not affect sexual development in F1 and F2 generations (number of pups, sex ration, relative AGD, nipple retention). Further, no effects were seen for physical and neuromotor development or motor activity. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day). The following studies support the selection of a new PoD for triclosan: • 10 mg/kg bw/day: decrease in daily sperm production after 8 weeks of oral exposure of Sprague-Dawley rats (Lan et al., 2015) (LOAEL: 50 mg/kg bw/day) • 8 mg/kg bw/day: no effects on uterus weight, estrous cyclic endpoints in F0 or F1 at the highest dose tested in a two-generation study in Wistar rats (Montagnini et al., 2018) • 8 mg/kg bw/day: no effects in Hershberger assay a; CITATION=Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day); CITATION_NUMBERS=[2021,3,5,2009,12,40]; REFERENCE=Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day); DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day)","dose":"NOAEL = 8 mg/kg bw/day.","duration":"8 weeks","effect":"e observed in F1 (testicular volume, interstitial content volume, seminiferous tubules volume, diameter of seminiferous tubules, and total length of seminiferous tubules). Triclosan did not affect sexual development in F1 and F2 generations (number of pups, sex ration, relative AGD, nipple retention). Further, no effects were seen for physical and neuromotor development or motor activity. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2021 SCCS comment on animal in vivo data for triclosan (Levels 3-5) In SCCP (2009) a NOAEL of 12 mg/kg bw/day was used as the PoD (LOAEL = 40 mg/kg bw/day). The following studies support the selection of a new PoD for triclosan: • 10 mg/kg bw/day: decrease in daily sperm production after 8 weeks of oral exposure of Sprague-Dawley rats (Lan et al., 2015) (LOAEL: 50 mg/kg bw/day) • 8 mg/kg bw/day: no effects on uterus weight, estrous cyclic endpoints in F0 or F1 at the highest dose tested in a two-generation study in Wistar rats (Montagnini et al., 2018) • 8 mg/kg bw/day: no effects in Hershberger assay a","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"12","page":30,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_031"} |
| Regulatory source |
- |
24 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Age categories | Dermal TCC as a preservative (µg/kg bw/d) | Dermal TCC in rinse -off products (µg/kg bw/d) | Oral * (µg/kg bw/d) | Aggregated (µg/kg bw/d) | NOAEL Adj (µg/kg bw/d) | MOS; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Age categories | Dermal TCC as a preservative (µg/kg bw/d) | Dermal TCC in rinse -off products (µg/kg bw/d) | Oral * (µg/kg bw/d) | Aggregated (µg/kg bw/d) | NOAEL Adj (µg/kg bw/d) | MOS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Age categories | Dermal TCC as a preservative (µg/kg bw/d) | Dermal TCC in rinse -off products (µg/kg bw/d) | Oral * (µg/kg bw/d) | Aggregated (µg/kg bw/d) | NOAEL Adj (µg/kg bw/d) | MOS","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Age categories | Dermal TCC as a preservative (µg/kg bw/d) | Dermal TCC in rinse -off products (µg/kg bw/d) | Oral * (µg/kg bw/d) | Aggregated (µg/kg bw/d) | NOAEL Adj (µg/kg bw/d) | MOS","page":55,"route":"oral","species":"","study_id":"sccs_o_265_noael_076"} |
| Regulatory source |
- |
25 |
mg/kg bw/d |
rat |
oral |
chronic |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=25; DOSE=For a 60kg adult, the total aggregate exposure was estimated to amount 0.03 mg/kg bw/d.; EFFECT=bar and liquid soaps and body wash. For a 60kg adult, the total aggregate exposure was estimated to amount 0.03 mg/kg bw/d. More than 60% of the total aggregate exposure from Triclocarban stems from the daily use of Triclocarban-containing liquid soaps. CALCULATION OF MARGIN OF SAFETY In accordance with the SCCP Notes of Guidance and in the absence of chronic dermal toxicity data, the results of an oral study have been used for the calculation of the Margin of Safety (MOS). The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5). To calculate a MOS for dermal exposure, a route-to-route extrapolation was made. The information on absorption after oral administration, i.e. 27%, was used to calculate an internal NOEL. This internal NOEL (25 x 0.27 = 6.75 mg/kg bw/d) is subsequently divided by the estimated dermal maximum systemic exposure dose, as presented in Table A2. The results of the MOS ca; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"For a 60kg adult, the total aggregate exposure was estimated to amount 0.03 mg/kg bw/d.","duration":"chronic","effect":"bar and liquid soaps and body wash. For a 60kg adult, the total aggregate exposure was estimated to amount 0.03 mg/kg bw/d. More than 60% of the total aggregate exposure from Triclocarban stems from the daily use of Triclocarban-containing liquid soaps. CALCULATION OF MARGIN OF SAFETY In accordance with the SCCP Notes of Guidance and in the absence of chronic dermal toxicity data, the results of an oral study have been used for the calculation of the Margin of Safety (MOS). The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5). To calculate a MOS for dermal exposure, a route-to-route extrapolation was made. The information on absorption after oral administration, i.e. 27%, was used to calculate an internal NOEL. This internal NOEL (25 x 0.27 = 6.75 mg/kg bw/d) is subsequently divided by the estimated dermal maximum systemic exposure dose, as presented in Table A2. The results of the MOS ca","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":33,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_015"} |
| Regulatory source |
- |
25 |
mg/kg bw/day |
rat |
- |
2-year |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=25; DOSE=The SCCS has selected a PoD based on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005).; EFFECT=__________________________________________ ___________________________________________________________________________________________ 34 Overall SCCS comment on endocrine activity Triclocarban In silico and in vitro studies provide evidence for a moderate estrogenic and androgenic potential of triclocarban. There is a further indication of a weak affinity for thyroid receptor. The human studies do not provide strong evidence of endocrine disruptive effects of Triclocarban. The SCCS has selected a PoD based on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005). Triclosan Several studies have demonstrated estrogenic activity and anti-androgenic activity of triclosan, through both direct and indirect MoA, confirming the androgen- and estrogen- mediated activity of triclosan. There is also evidence of endocrine activity of triclosan from in vivo animal studies, whereas there are either no or inconsistent findings in human studies. The SCCS has selected a PoD based on NOAEL of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The SCCS has selected a PoD based on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005).","duration":"2-year","effect":"__________________________________________ ___________________________________________________________________________________________ 34 Overall SCCS comment on endocrine activity Triclocarban In silico and in vitro studies provide evidence for a moderate estrogenic and androgenic potential of triclocarban. There is a further indication of a weak affinity for thyroid receptor. The human studies do not provide strong evidence of endocrine disruptive effects of Triclocarban. The SCCS has selected a PoD based on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005). Triclosan Several studies have demonstrated estrogenic activity and anti-androgenic activity of triclosan, through both direct and indirect MoA, confirming the androgen- and estrogen- mediated activity of triclosan. There is also evidence of endocrine activity of triclosan from in vivo animal studies, whereas there are either no or inconsistent findings in human studies. The SCCS has selected a PoD based on NOAEL of","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":34,"route":"","species":"rat","study_id":"sccs_o_265_noael_036"} |
| Regulatory source |
- |
25 |
mg/kg bw/day |
rat |
oral |
2-year |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=25; DOSE=SED (mg/kg bw/day) for aggregated exposures for triclosan by age group Oral products Dermal products All products Age category Age (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467...; EFFECT=________________________________________ 48 Table 17. SED (mg/kg bw/day) for aggregated exposures for triclosan by age group Oral products Dermal products All products Age category Age (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467 0.52372 Adolescents 14-18 0.07720 0.39029 0.46749 3.6 SAFETY EVALUATION 3.6.1 SAFETY EVALUATION OF TRICLOCARBAN A NOAEL of 25 mg/kg bw/day was selected from a 2-year chronic feeding study in rats. The information on absorption after oral administration, i.e. 27%, was used to calculate an adjusted NOAEL of 6.75 mg/kg bw/day (25 mg/kg bw/day x 27% = 6.75 mg/kg bw/day). 3.6.1.1 Safety evaluation of triclocarban in adults MoS calculations for the use of triclocarban as an ingredient in the rinse-off products and as a preservative for adults are shown in Table 18 and Table 19, respectively. Table 18. MoS calculations for triclocarban; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SED (mg/kg bw/day) for aggregated exposures for triclosan by age group Oral products Dermal products All products Age category Age (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467...","duration":"2-year","effect":"________________________________________ 48 Table 17. SED (mg/kg bw/day) for aggregated exposures for triclosan by age group Oral products Dermal products All products Age category Age (yrs) SEDoral SEDdermal SED total Infants 0.5-1 0.06819 0.68675 0.75494 Toddler 1-3 0.05043 0.64705 0.69748 Children 3-6 0.02598 0.52183 0.54781 Children 6-10 0.20487 0.52183 0.72670 Adolescents 10-14 0.10905 0.41467 0.52372 Adolescents 14-18 0.07720 0.39029 0.46749 3.6 SAFETY EVALUATION 3.6.1 SAFETY EVALUATION OF TRICLOCARBAN A NOAEL of 25 mg/kg bw/day was selected from a 2-year chronic feeding study in rats. The information on absorption after oral administration, i.e. 27%, was used to calculate an adjusted NOAEL of 6.75 mg/kg bw/day (25 mg/kg bw/day x 27% = 6.75 mg/kg bw/day). 3.6.1.1 Safety evaluation of triclocarban in adults MoS calculations for the use of triclocarban as an ingredient in the rinse-off products and as a preservative for adults are shown in Table 18 and Table 19, respectively. Table 18. MoS calculations for triclocarban","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":48,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_038"} |
| Regulatory source |
- |
25 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Table 25. SED calculation for triclosan in oral products by age categories: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; DOSE=Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; EFFECT=Table 25. SED calculation for triclosan in oral products by age categories: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","duration":"","effect":"Table 25. SED calculation for triclosan in oral products by age categories: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Table 25. SED calculation for triclosan in oral products by age categories: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_097"} |
| Regulatory source |
- |
26 |
- |
- |
dermal |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; DOSE=Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; EFFECT=Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","duration":"","effect":"Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure: Age category | Age (yrs) | Triclosan content (%) | SED dermal (mg/kg bw/d) | NOAEL (mg/kg bw/d) | MoS","page":57,"route":"dermal","species":"","study_id":"sccs_o_265_noael_111"} |
| Regulatory source |
- |
27 |
% |
rat |
oral |
chronic |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=27; DOSE=The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5).; EFFECT=nd in the absence of chronic dermal toxicity data, the results of an oral study have been used for the calculation of the Margin of Safety (MOS). The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5). To calculate a MOS for dermal exposure, a route-to-route extrapolation was made. The information on absorption after oral administration, i.e. 27%, was used to calculate an internal NOEL. This internal NOEL (25 x 0.27 = 6.75 mg/kg bw/d) is subsequently divided by the estimated dermal maximum systemic exposure dose, as presented in Table A2. The results of the MOS calculations for the individual as well as the aggregate exposure scenarios are presented in Table A3. Table A3: Calculated Margins of Safety for uses of Triclocarban in liquid and bar soaps and shower gels Product Adults Bar Soap Exposure 0.0074 mg/kg bw/d MOS 912 Liquid Soap Exposure 0.0195 mg/kg bw/d MOS 346 Body Wash Exposure 0.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5).","duration":"chronic","effect":"nd in the absence of chronic dermal toxicity data, the results of an oral study have been used for the calculation of the Margin of Safety (MOS). The lowest no observed effect level (NOEL) for Triclocarban was determined to be 25 mg/kg bw/d on the basis of a 2 year chronic oral feeding study in Sprague Dawley rats (see section 3.3.5). To calculate a MOS for dermal exposure, a route-to-route extrapolation was made. The information on absorption after oral administration, i.e. 27%, was used to calculate an internal NOEL. This internal NOEL (25 x 0.27 = 6.75 mg/kg bw/d) is subsequently divided by the estimated dermal maximum systemic exposure dose, as presented in Table A2. The results of the MOS calculations for the individual as well as the aggregate exposure scenarios are presented in Table A3. Table A3: Calculated Margins of Safety for uses of Triclocarban in liquid and bar soaps and shower gels Product Adults Bar Soap Exposure 0.0074 mg/kg bw/d MOS 912 Liquid Soap Exposure 0.0195 mg/kg bw/d MOS 346 Body Wash Exposure 0.","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"%","noael_value":"27","page":33,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_016"} |
| Regulatory source |
- |
27 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Table 27. SED Calculation for triclosan in rinse-off products by age categories: Ag | e Triclos | an content | SED derm | al | NOAEL; EFFECT=Table 27. SED Calculation for triclosan in rinse-off products by age categories: Ag | e Triclos | an content | SED derm | al | NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 27. SED Calculation for triclosan in rinse-off products by age categories: Ag | e Triclos | an content | SED derm | al | NOAEL","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Table 27. SED Calculation for triclosan in rinse-off products by age categories: Ag | e Triclos | an content | SED derm | al | NOAEL","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_128"} |
| Regulatory source |
- |
28 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Age category | Age (yrs) | SED oral | SED dermal | SED total | NOAEL | MoS oral | MoS dermal | MoS total; EFFECT=Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Age category | Age (yrs) | SED oral | SED dermal | SED total | NOAEL | MoS oral | MoS dermal | MoS total; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Age category | Age (yrs) | SED oral | SED dermal | SED total | NOAEL | MoS oral | MoS dermal | MoS total","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Table 28. Calculation of MoS for aggregated exposures of triclosan by age categories: Age category | Age (yrs) | SED oral | SED dermal | SED total | NOAEL | MoS oral | MoS dermal | MoS total","page":58,"route":"oral","species":"","study_id":"sccs_o_265_noael_144"} |
| Regulatory source |
- |
37.5 |
mg/kg/day |
rat |
oral |
8-months |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=37.5; DOSE=_________________________________________________ ___________________________________________________________________________________________73 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Hua et al.; LOAEL_VALUE=8 mg/kg bw/d; EFFECT=_________________________________________________ ___________________________________________________________________________________________73 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Hua et al. 2017 ICR mice Gestational and non-gestational female mice Exposure from GD5-GD17 Doses: 1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 NOAEL =1 Louis et al. 2017 Female Wistar rats 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence NOAEL= 4.69; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"_________________________________________________ ___________________________________________________________________________________________73 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Hua et al.","duration":"8-months","effect":"_________________________________________________ ___________________________________________________________________________________________73 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Hua et al. 2017 ICR mice Gestational and non-gestational female mice Exposure from GD5-GD17 Doses: 1, 4, 8 mg/kg bw/d (gestational), 8 mg/kg bw/d (non-gestational) n=10 Gestational mice ↓ T3, T4 at 4 and 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 NOAEL =1 Louis et al. 2017 Female Wistar rats 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence NOAEL= 4.69","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"8 mg/kg bw/d","noael_unit":"mg/kg/day","noael_value":"37.5","page":73,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_058"} |
| Regulatory source |
- |
37.5 |
mg/kg |
rat |
oral |
8-months |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=37.5; DOSE=2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence NOAEL= 4.69; EFFECT=nd 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 NOAEL =1 Louis et al. 2017 Female Wistar rats 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence NOAEL= 4.69; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence NOAEL= 4.69","duration":"8-months","effect":"nd 8 ↓ free T4 at 8 ↔ estrogen, progesteron ↔ body weight Non-gestational mice: ↓ T3, T4, free T4 at 8 NOAEL =1 Louis et al. 2017 Female Wistar rats 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence NOAEL= 4.69","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"37.5","page":73,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_059"} |
| Regulatory source |
- |
37.5 |
mg/kg/day |
rat |
oral |
8-months |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=37.5; DOSE=2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE | ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence | NOAEL= 4.69; EFFECT=Unlabeled table on page 73: Louis et al. | 2017 | Female Wistar rats | 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE | ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence | NOAEL= 4.69; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE | ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence | NOAEL= 4.69","duration":"8-months","effect":"Unlabeled table on page 73: Louis et al. | 2017 | Female Wistar rats | 8-months oral gavage exposure of female rats Doses: 2.35, 4.69, 9.375, 37.5 mg/kg/day of triclosan or 1 ug/kg/day of EE n= 13-15/group, n=6 for EE | ↓ T4 at 9.375 and 37.5 mg/kg ↔ T3, TSH, thyroid weight, histology (follicle height, colloid volume) ↑ cyp2b2 gene expression in liver at 37.5 mg/kg ↔ Cyp3a23, Sult1c1/1c3, Sult1b1, Ugta1 ↔ estrous cyclicity or senescence | NOAEL= 4.69","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg/day","noael_value":"37.5","page":73,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_168"} |
| Regulatory source |
- |
56 |
- |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:____________ ___________________________________________________________________________________________ 56 3.6.2.2 Safety evaluation of triclosan in children MoS calculations for separate product types and aggregated exposures for each product category are shown in Tables 25-27. MoS calculations for aggregated exposure for all product types by age are shown in Table 28. Table 25. SED calculation for triclosan in oral products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children 3-6 0.3 0.02598 8 308 Children 6-10 0.3 0.01785 8 448 Adolescents 10- 14 0.3 0.00951 8 841 Adolescents 14- 18 0.3 0.00672 8 1 190 Mouthwash Children 6-10 0.2 0.18702 8 43 Adolescents 10- 14 0.2 0.09954 8 80 Adolescents 14- 18 0.2 0.07048 8 114 Aggregated exposure Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children1 3-6 0.3 0.02598 8 308 Children2 6-10 0.3/0.2 0.20487 8 39 Adolescents; DOSE=SED calculation for triclosan in oral products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children 3-6 0.3 0.02598 8 308 Children 6-10 0.3 0.01785 8 448 Adolescents 10- 14 0.3 0.00951 8 841 Adolescents 14- 18...; EFFECT=____________ ___________________________________________________________________________________________ 56 3.6.2.2 Safety evaluation of triclosan in children MoS calculations for separate product types and aggregated exposures for each product category are shown in Tables 25-27. MoS calculations for aggregated exposure for all product types by age are shown in Table 28. Table 25. SED calculation for triclosan in oral products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children 3-6 0.3 0.02598 8 308 Children 6-10 0.3 0.01785 8 448 Adolescents 10- 14 0.3 0.00951 8 841 Adolescents 14- 18 0.3 0.00672 8 1 190 Mouthwash Children 6-10 0.2 0.18702 8 43 Adolescents 10- 14 0.2 0.09954 8 80 Adolescents 14- 18 0.2 0.07048 8 114 Aggregated exposure Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children1 3-6 0.3 0.02598 8 308 Children2 6-10 0.3/0.2 0.20487 8 39 Adolescents; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SED calculation for triclosan in oral products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children 3-6 0.3 0.02598 8 308 Children 6-10 0.3 0.01785 8 448 Adolescents 10- 14 0.3 0.00951 8 841 Adolescents 14- 18...","duration":"","effect":"____________ ___________________________________________________________________________________________ 56 3.6.2.2 Safety evaluation of triclosan in children MoS calculations for separate product types and aggregated exposures for each product category are shown in Tables 25-27. MoS calculations for aggregated exposure for all product types by age are shown in Table 28. Table 25. SED calculation for triclosan in oral products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children 3-6 0.3 0.02598 8 308 Children 6-10 0.3 0.01785 8 448 Adolescents 10- 14 0.3 0.00951 8 841 Adolescents 14- 18 0.3 0.00672 8 1 190 Mouthwash Children 6-10 0.2 0.18702 8 43 Adolescents 10- 14 0.2 0.09954 8 80 Adolescents 14- 18 0.2 0.07048 8 114 Aggregated exposure Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children1 3-6 0.3 0.02598 8 308 Children2 6-10 0.3/0.2 0.20487 8 39 Adolescents","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:____________ ___________________________________________________________________________________________ 56 3.6.2.2 Safety evaluation of triclosan in children MoS calculations for separate product types and aggregated exposures for each product category are shown in Tables 25-27. MoS calculations for aggregated exposure for all product types by age are shown in Table 28. Table 25. SED calculation for triclosan in oral products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children 3-6 0.3 0.02598 8 308 Children 6-10 0.3 0.01785 8 448 Adolescents 10- 14 0.3 0.00951 8 841 Adolescents 14- 18 0.3 0.00672 8 1 190 Mouthwash Children 6-10 0.2 0.18702 8 43 Adolescents 10- 14 0.2 0.09954 8 80 Adolescents 14- 18 0.2 0.07048 8 114 Aggregated exposure Infants 0.5-1 0.3 0.06819 8 117 Toddler 1-3 0.3 0.05043 8 159 Children1 3-6 0.3 0.02598 8 308 Children2 6-10 0.3/0.2 0.20487 8 39 Adolescents","page":56,"route":"oral","species":"","study_id":"sccs_o_265_noael_044"} |
| Regulatory source |
- |
69 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 69: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 69: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 69: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 69: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":69,"route":"","species":"","study_id":"sccs_o_265_noael_157"} |
| Regulatory source |
- |
70 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 70: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 70: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 70: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 70: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":70,"route":"","species":"","study_id":"sccs_o_265_noael_159"} |
| Regulatory source |
- |
71 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 71: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 71: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 71: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 71: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":71,"route":"","species":"","study_id":"sccs_o_265_noael_161"} |
| Regulatory source |
- |
72 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 72: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 72: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 72: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 72: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":72,"route":"","species":"","study_id":"sccs_o_265_noael_165"} |
| Regulatory source |
- |
73 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 73: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 73: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 73: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 73: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":73,"route":"","species":"","study_id":"sccs_o_265_noael_166"} |
| Regulatory source |
- |
74 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 74: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 74: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 74: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 74: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":74,"route":"","species":"","study_id":"sccs_o_265_noael_169"} |
| Regulatory source |
- |
75 |
mg/kg bw/d |
rat |
oral |
23 months |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=75; DOSE=An increase in incidence of small and flaccid testes was observed in males at 250 mg/kg bw/d that died spontaneously or were killed moribund between 12 and 23 months.; EFFECT=o microscopic changes were noted in any of the organs to account for these increased organ weights, therefore the changes may not have been biologically significant. An increase in incidence of small and flaccid testes was observed in males at 250 mg/kg bw/d that died spontaneously or were killed moribund between 12 and 23 months. A similar treatment-related increase was not apparent at terminal sacrifice. There was no evidence for dose-related increases in tumour incidence at any site. Based on these results, the NOEL and LOEL for the study were considered to be 25 and 75 mg/kg bw/d, respectively. The study was performed based on a protocol approved by Food and Drug Administration (i.e., FDA). Ref.: 22 Wright et al. (1975) reported a chronic toxicity study in which rats were fed with a diet containing doses of Triclocarban of 3000 and 10000 ppm resulting in a degeneration of the germinal epithelium lining of the seminiferous tubules, atrophy of the tubules, and oligospermia after 6 months of exposure. No testicular lesions we; CITATION=Ref.: 22 Wright et al; CITATION_NUMBERS=[22]; REFERENCE=Ref.: 22 Wright et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 22 Wright et al","dose":"An increase in incidence of small and flaccid testes was observed in males at 250 mg/kg bw/d that died spontaneously or were killed moribund between 12 and 23 months.","duration":"23 months","effect":"o microscopic changes were noted in any of the organs to account for these increased organ weights, therefore the changes may not have been biologically significant. An increase in incidence of small and flaccid testes was observed in males at 250 mg/kg bw/d that died spontaneously or were killed moribund between 12 and 23 months. A similar treatment-related increase was not apparent at terminal sacrifice. There was no evidence for dose-related increases in tumour incidence at any site. Based on these results, the NOEL and LOEL for the study were considered to be 25 and 75 mg/kg bw/d, respectively. The study was performed based on a protocol approved by Food and Drug Administration (i.e., FDA). Ref.: 22 Wright et al. (1975) reported a chronic toxicity study in which rats were fed with a diet containing doses of Triclocarban of 3000 and 10000 ppm resulting in a degeneration of the germinal epithelium lining of the seminiferous tubules, atrophy of the tubules, and oligospermia after 6 months of exposure. No testicular lesions we","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":21,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_007"} |
| Regulatory source |
- |
75 |
mg/kg bw/d |
rat |
oral |
8-week |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=75; DOSE=No effects were observed in the oral gavage study at the highest dose level of 1000 mg/kg bw/d.; EFFECT=city). No effects were observed in the oral gavage study at the highest dose level of 1000 mg/kg bw/d. In the 8-week study, there were no mortality or signs of toxicity other than a reduced food consumption and a decrease in the mean body weight of the rats of the highest exposure group (i.e., 250 mg/kg bw/d). There were a number of critical weaknesses relative to the study design such as the absence of a control group, histology of tissues and blood chemistry and hence the proposed no observed effect level (i.e., NOEL) of 75 mg/kg bw/d should be treated in light of these study limitations. In the 2-year chronic feeding study, the rats were fed with a diet containing Triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in foo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"No effects were observed in the oral gavage study at the highest dose level of 1000 mg/kg bw/d.","duration":"8-week","effect":"city). No effects were observed in the oral gavage study at the highest dose level of 1000 mg/kg bw/d. In the 8-week study, there were no mortality or signs of toxicity other than a reduced food consumption and a decrease in the mean body weight of the rats of the highest exposure group (i.e., 250 mg/kg bw/d). There were a number of critical weaknesses relative to the study design such as the absence of a control group, histology of tissues and blood chemistry and hence the proposed no observed effect level (i.e., NOEL) of 75 mg/kg bw/d should be treated in light of these study limitations. In the 2-year chronic feeding study, the rats were fed with a diet containing Triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in foo","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_019"} |
| Regulatory source |
- |
75 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 75: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 75: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 75: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":75,"route":"","species":"","study_id":"sccs_o_265_noael_172"} |
| Regulatory source |
- |
76 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 76: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 76: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 76: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 76: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":76,"route":"","species":"","study_id":"sccs_o_265_noael_175"} |
| Regulatory source |
- |
77 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 77: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 77: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 77: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 77: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":77,"route":"","species":"","study_id":"sccs_o_265_noael_178"} |
| Regulatory source |
- |
78 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 78: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 78: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 78: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 78: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":78,"route":"","species":"","study_id":"sccs_o_265_noael_179"} |
| Regulatory source |
- |
79 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 79: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 79: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 79: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 79: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":79,"route":"","species":"","study_id":"sccs_o_265_noael_182"} |
| Regulatory source |
- |
80 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Unlabeled table on page 80: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); DOSE=Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 80: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 80: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 80: Reference | Year | _____________ Species | ________________________________ Method | _______________ Results | _____________ Comments | NOAEL/LOAEL (mg/kg bw/d)","page":80,"route":"","species":"","study_id":"sccs_o_265_noael_185"} |
| Regulatory source |
- |
100 |
% |
- |
oral |
10 years |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=100; DOSE=3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al.; EFFECT=off products (1.5%), mouthwash use excluded. * Without mouth wash Aggregated exposure to triclocarban used as a preservative (0.2%) and in rinse–off products (1.5%) result in a MoS below 100 for children below the age of 10 years. 3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al. (2018, 2020) and Pernoncini et al. (2018) is used for the calculation of MoS. An oral availability of 100% was assumed, and thus no adjustments to the NOAEL were performed. 3.6.2.1 Safety evaluation of triclosan in adult MoS calculations for separate product types and aggregated exposures are shown in Table 24. Since body lotions contribute significantly to the SED for aggregated exposures, MoS for aggregated exposures not including body lotion is also calculated. Table 24. Calculation of total SED for aggregated exposures of triclosan Product type Triclosan content (%) SEDoral or SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste 0.3 0.00648 8 1234 Mouthwash; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al.","duration":"10 years","effect":"off products (1.5%), mouthwash use excluded. * Without mouth wash Aggregated exposure to triclocarban used as a preservative (0.2%) and in rinse–off products (1.5%) result in a MoS below 100 for children below the age of 10 years. 3.6.2 SAFETY EVALUATION OF TRICLOSAN A NOAEL of 8 mg/kg bw/day based on the highest dose tested in the studies by Montagnini et al. (2018, 2020) and Pernoncini et al. (2018) is used for the calculation of MoS. An oral availability of 100% was assumed, and thus no adjustments to the NOAEL were performed. 3.6.2.1 Safety evaluation of triclosan in adult MoS calculations for separate product types and aggregated exposures are shown in Table 24. Since body lotions contribute significantly to the SED for aggregated exposures, MoS for aggregated exposures not including body lotion is also calculated. Table 24. Calculation of total SED for aggregated exposures of triclosan Product type Triclosan content (%) SEDoral or SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste 0.3 0.00648 8 1234 Mouthwash","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"%","noael_value":"100","page":55,"route":"oral","species":"","study_id":"sccs_o_265_noael_041"} |
| Regulatory source |
- |
100 |
% |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=100; DOSE=Calculation of total SED for aggregated exposures of triclosan Product type Triclosan content (%) SEDoral or SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste 0.3 0.00648 8 1234 Mouthwash 0.2 0.0651 8 1 23 Deodorant stick 0.3 0.00303 8 2 640 Body lotion 0.3 0.37514 8 21 Face powder 0.3 0.00593 8 1 349 Blemish concealer 0.3 0.00060 8 13 33...; EFFECT=lity of 100% was assumed, and thus no adjustments to the NOAEL were performed. 3.6.2.1 Safety evaluation of triclosan in adult MoS calculations for separate product types and aggregated exposures are shown in Table 24. Since body lotions contribute significantly to the SED for aggregated exposures, MoS for aggregated exposures not including body lotion is also calculated. Table 24. Calculation of total SED for aggregated exposures of triclosan Product type Triclosan content (%) SEDoral or SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste 0.3 0.00648 8 1234 Mouthwash 0.2 0.0651 8 1 23 Deodorant stick 0.3 0.00303 8 2 640 Body lotion 0.3 0.37514 8 21 Face powder 0.3 0.00593 8 1 349 Blemish concealer 0.3 0.00060 8 13 333 Hand soap 0.03 0.00659 8 1 214 Shower gel 0.03 0.01919 8 417 Aggregated exposure 0.48206 8 17 Aggregated exposure not including body lotion 0.107 8 75 With the exception of body lotion, each separate product type has a MoS above 100. Aggregated exposure to triclosan results in a MoS lower than 100 due to t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Calculation of total SED for aggregated exposures of triclosan Product type Triclosan content (%) SEDoral or SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste 0.3 0.00648 8 1234 Mouthwash 0.2 0.0651 8 1 23 Deodorant stick 0.3 0.00303 8 2 640 Body lotion 0.3 0.37514 8 21 Face powder 0.3 0.00593 8 1 349 Blemish concealer 0.3 0.00060 8 13 33...","duration":"","effect":"lity of 100% was assumed, and thus no adjustments to the NOAEL were performed. 3.6.2.1 Safety evaluation of triclosan in adult MoS calculations for separate product types and aggregated exposures are shown in Table 24. Since body lotions contribute significantly to the SED for aggregated exposures, MoS for aggregated exposures not including body lotion is also calculated. Table 24. Calculation of total SED for aggregated exposures of triclosan Product type Triclosan content (%) SEDoral or SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Toothpaste 0.3 0.00648 8 1234 Mouthwash 0.2 0.0651 8 1 23 Deodorant stick 0.3 0.00303 8 2 640 Body lotion 0.3 0.37514 8 21 Face powder 0.3 0.00593 8 1 349 Blemish concealer 0.3 0.00060 8 13 333 Hand soap 0.03 0.00659 8 1 214 Shower gel 0.03 0.01919 8 417 Aggregated exposure 0.48206 8 17 Aggregated exposure not including body lotion 0.107 8 75 With the exception of body lotion, each separate product type has a MoS above 100. Aggregated exposure to triclosan results in a MoS lower than 100 due to t","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"%","noael_value":"100","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_042"} |
| Regulatory source |
- |
100 |
mg/kg/d |
mouse |
- |
12 week |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=100; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; LOAEL_VALUE=100 mg/kg/d; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________74 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Cao et al. 2018 Female ICR mice 12 week old female mice exposed for 50 days Doses: 1, 10, 100 mg/kg/d ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus Levothyroxine rescues estrous cycling, follicular development and ovulat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"12 week","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________74 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Cao et al. 2018 Female ICR mice 12 week old female mice exposed for 50 days Doses: 1, 10, 100 mg/kg/d ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus Levothyroxine rescues estrous cycling, follicular development and ovulat","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"100 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"100","page":74,"route":"","species":"mouse","study_id":"sccs_o_265_noael_060"} |
| Regulatory source |
- |
100 |
mg/kg/d |
mouse |
- |
12 week |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=100; DOSE=1, 10, 100 mg/kg/d | ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus L...; EFFECT=Unlabeled table on page 74: Cao et al. | 2018 | Female ICR mice | 12 week old female mice exposed for 50 days Doses: 1, 10, 100 mg/kg/d | ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus Levothyroxine rescues estrous cycling, follicular development and ovulation | NOAEL = 1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"1, 10, 100 mg/kg/d | ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus L...","duration":"12 week","effect":"Unlabeled table on page 74: Cao et al. | 2018 | Female ICR mice | 12 week old female mice exposed for 50 days Doses: 1, 10, 100 mg/kg/d | ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus Levothyroxine rescues estrous cycling, follicular development and ovulation | NOAEL = 1","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg/d","noael_value":"100","page":74,"route":"","species":"mouse","study_id":"sccs_o_265_noael_170"} |
| Regulatory source |
- |
=100 |
mg/kg |
rat |
oral |
31 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 100; DOSE=0, 50, 100, 200 mg/kg/day n = 6/group | ↓ relative testis weight at 100- 200 ↓ relative epididymis weight at 200 histopathologic alterations in testis at 100-200 ↓ LH at all doses ↓ Testosterone at 100-200 ↓ steroidogenic proteins at 100- 200:; LOAEL_VALUE=100 mg/kg; EFFECT=Unlabeled table on page 75: Ha et al. | 2018 | Male Sprague- Dawley rats | 31 days gavage exposure to male rats Doses: 0, 50, 100, 200 mg/kg/day n = 6/group | ↓ relative testis weight at 100- 200 ↓ relative epididymis weight at 200 histopathologic alterations in testis at 100-200 ↓ LH at all doses ↓ Testosterone at 100-200 ↓ steroidogenic proteins at 100- 200: SRB1, StAR, 3ß-HSD, P450c17 ↓ mRNA: LHR at all doses, AR at 200 ↑ miR-142 and | LOAEL = 100 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0, 50, 100, 200 mg/kg/day n = 6/group | ↓ relative testis weight at 100- 200 ↓ relative epididymis weight at 200 histopathologic alterations in testis at 100-200 ↓ LH at all doses ↓ Testosterone at 100-200 ↓ steroidogenic proteins at 100- 200:","duration":"31 days","effect":"Unlabeled table on page 75: Ha et al. | 2018 | Male Sprague- Dawley rats | 31 days gavage exposure to male rats Doses: 0, 50, 100, 200 mg/kg/day n = 6/group | ↓ relative testis weight at 100- 200 ↓ relative epididymis weight at 200 histopathologic alterations in testis at 100-200 ↓ LH at all doses ↓ Testosterone at 100-200 ↓ steroidogenic proteins at 100- 200: SRB1, StAR, 3ß-HSD, P450c17 ↓ mRNA: LHR at all doses, AR at 200 ↑ miR-142 and | LOAEL = 100 mg/kg","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"100 mg/kg","noael_unit":"mg/kg","noael_value":"= 100","page":75,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_174"} |
| Regulatory source |
- |
187.5 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=187.5; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________6...; LOAEL_VALUE=187.5 mg/kg bw/d; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________69 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Jung et al. 2012 Immature female Sprague-Dawley rats Oral gavage, PND19-21 Doses: 7.5, 37.5, and 187.5 mg/kg bw/d EE (positive control): 1 mg/kg bw/d n = 8/group All doses of triclosan significantly increased uterine wet weight (none dose-response). In addition, the expressions of calbindin-D9k (CaBP-9k) and complement C3 (C3) were significantly induced by triclosan. LOAEL = 7.5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________6...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________69 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Jung et al. 2012 Immature female Sprague-Dawley rats Oral gavage, PND19-21 Doses: 7.5, 37.5, and 187.5 mg/kg bw/d EE (positive control): 1 mg/kg bw/d n = 8/group All doses of triclosan significantly increased uterine wet weight (none dose-response). In addition, the expressions of calbindin-D9k (CaBP-9k) and complement C3 (C3) were significantly induced by triclosan. LOAEL = 7.5","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"187.5 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"187.5","page":69,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_051"} |
| Regulatory source |
- |
187.5 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=187.5; DOSE=7.5, 37.5, and 187.5 mg/kg bw/d EE (positive control):; EFFECT=Unlabeled table on page 69: Jung et al. | 2012 | Immature female Sprague-Dawley rats | Oral gavage, PND19-21 Doses: 7.5, 37.5, and 187.5 mg/kg bw/d EE (positive control): 1 mg/kg bw/d n = 8/group | All doses of triclosan significantly increased uterine wet weight (none dose-response). In addition, the expressions of calbindin-D9k (CaBP-9k) and complement C3 (C3) were significantly induced by triclosan. | LOAEL = 7.5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"7.5, 37.5, and 187.5 mg/kg bw/d EE (positive control):","duration":"","effect":"Unlabeled table on page 69: Jung et al. | 2012 | Immature female Sprague-Dawley rats | Oral gavage, PND19-21 Doses: 7.5, 37.5, and 187.5 mg/kg bw/d EE (positive control): 1 mg/kg bw/d n = 8/group | All doses of triclosan significantly increased uterine wet weight (none dose-response). In addition, the expressions of calbindin-D9k (CaBP-9k) and complement C3 (C3) were significantly induced by triclosan. | LOAEL = 7.5","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"187.5","page":69,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_158"} |
| Regulatory source |
- |
200 |
mg/kg |
rat |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=200; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________75 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) ↓ daily sperm production at 250-750 ↓ AR protein expression at 25 Farmer et al. 2018 Male, castrated rat Hershberger assay, oral gavage for 10 days Doses: 50, 200 mg/kg n=5-7/group ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights No effect on androgen synthesis or activity LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction) Ha et al. 2018 Male Sprague- Dawley rats 31 days gavage exposure to male rats Doses: 0, 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"10 days","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________75 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) ↓ daily sperm production at 250-750 ↓ AR protein expression at 25 Farmer et al. 2018 Male, castrated rat Hershberger assay, oral gavage for 10 days Doses: 50, 200 mg/kg n=5-7/group ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights No effect on androgen synthesis or activity LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction) Ha et al. 2018 Male Sprague- Dawley rats 31 days gavage exposure to male rats Doses: 0, 50","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"200","page":75,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_062"} |
| Regulatory source |
- |
200 |
mg/kg/day |
rat |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=200; DOSE=____________________________________________________________________75 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) ↓ daily sperm production at 250-750 ↓ AR protein expression at 25 Farmer et al.; LOAEL_VALUE=100 mg/kg; EFFECT=____________________________________________________________________75 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) ↓ daily sperm production at 250-750 ↓ AR protein expression at 25 Farmer et al. 2018 Male, castrated rat Hershberger assay, oral gavage for 10 days Doses: 50, 200 mg/kg n=5-7/group ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights No effect on androgen synthesis or activity LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction) Ha et al. 2018 Male Sprague- Dawley rats 31 days gavage exposure to male rats Doses: 0, 50, 100, 200 mg/kg/day n = 6/group ↓ relative testis weight at 100- 200 ↓ relative epididymis weight at 200 histopathologic alterations in testis at 100-200 ↓ LH at all doses ↓ Testosterone at 100-200 ↓ steroidogenic proteins at 100- 200: SRB1, StAR, 3ß-HSD, P450c17 ↓ mRNA: LHR at all doses, AR at 200 ↑ miR-142 and LOAEL = 100 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"____________________________________________________________________75 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) ↓ daily sperm production at 250-750 ↓ AR protein expression at 25 Farmer et al.","duration":"10 days","effect":"____________________________________________________________________75 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) ↓ daily sperm production at 250-750 ↓ AR protein expression at 25 Farmer et al. 2018 Male, castrated rat Hershberger assay, oral gavage for 10 days Doses: 50, 200 mg/kg n=5-7/group ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights No effect on androgen synthesis or activity LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction) Ha et al. 2018 Male Sprague- Dawley rats 31 days gavage exposure to male rats Doses: 0, 50, 100, 200 mg/kg/day n = 6/group ↓ relative testis weight at 100- 200 ↓ relative epididymis weight at 200 histopathologic alterations in testis at 100-200 ↓ LH at all doses ↓ Testosterone at 100-200 ↓ steroidogenic proteins at 100- 200: SRB1, StAR, 3ß-HSD, P450c17 ↓ mRNA: LHR at all doses, AR at 200 ↑ miR-142 and LOAEL = 100 mg/kg","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"100 mg/kg","noael_unit":"mg/kg/day","noael_value":"200","page":75,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_063"} |
| Regulatory source |
- |
200 |
mg/kg bw/day |
rat |
oral |
31 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=200; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; LOAEL_VALUE=4000 mg/kg bw/day; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________78 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Zhang et al. 2018 Male Sprague- Dawley rats 31 days gavage exposure of 23 day old male rats Doses: 50, 100, 200 mg/kg bw/day n=6 ↓ T3 and T4 at all doses ↔ TSH Histopathologic changes of thyroid ↑ Relative liver weight (%) at 200 ↑ hepatic enzymes (Ugt2b1, CYP2b1 at all doses, CYP1a1, CYP3a1 and Sult1c1 at 100 and 200, CYP1a2 at 200) LOAEL= 50 Tabari et al. 2019 Adult NMRI mice Adult male NMRI mice given oral gavage for 14 days Doses: 1000, 2000 and 4000 mg/kg bw/day n=8 ↓ total distance moveme; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"31 days","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________78 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Zhang et al. 2018 Male Sprague- Dawley rats 31 days gavage exposure of 23 day old male rats Doses: 50, 100, 200 mg/kg bw/day n=6 ↓ T3 and T4 at all doses ↔ TSH Histopathologic changes of thyroid ↑ Relative liver weight (%) at 200 ↑ hepatic enzymes (Ugt2b1, CYP2b1 at all doses, CYP1a1, CYP3a1 and Sult1c1 at 100 and 200, CYP1a2 at 200) LOAEL= 50 Tabari et al. 2019 Adult NMRI mice Adult male NMRI mice given oral gavage for 14 days Doses: 1000, 2000 and 4000 mg/kg bw/day n=8 ↓ total distance moveme","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"4000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"200","page":78,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_068"} |
| Regulatory source |
- |
200 |
mg/kg |
rat |
- |
8 weeks |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=200; DOSE=0, 10, 50 and 200 mg/kg n = 8/group | ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 | NOAEL = 10; EFFECT=Unlabeled table on page 71: Lan et al. | 2015 | Male Sprague- Dawley rats | Intragastric exposure of adult rats for 8 weeks Doses: 0, 10, 50 and 200 mg/kg n = 8/group | ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 | NOAEL = 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0, 10, 50 and 200 mg/kg n = 8/group | ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 | NOAEL = 10","duration":"8 weeks","effect":"Unlabeled table on page 71: Lan et al. | 2015 | Male Sprague- Dawley rats | Intragastric exposure of adult rats for 8 weeks Doses: 0, 10, 50 and 200 mg/kg n = 8/group | ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 | NOAEL = 10","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"200","page":71,"route":"","species":"rat","study_id":"sccs_o_265_noael_162"} |
| Regulatory source |
- |
200 |
mg/kg |
rat |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=200; DOSE=50, 200 mg/kg n=5-7/group | ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights | No effect on androgen synthesis or activity | LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction); EFFECT=Unlabeled table on page 75: Farmer et al. | 2018 | Male, castrated rat | Hershberger assay, oral gavage for 10 days Doses: 50, 200 mg/kg n=5-7/group | ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights | No effect on androgen synthesis or activity | LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"50, 200 mg/kg n=5-7/group | ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights | No effect on androgen synthesis or activity | LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction)","duration":"10 days","effect":"Unlabeled table on page 75: Farmer et al. | 2018 | Male, castrated rat | Hershberger assay, oral gavage for 10 days Doses: 50, 200 mg/kg n=5-7/group | ↓ T4 at 200 ↓ T4 at both doses in presence of testosterone proprionate ↔ weight of thyroid and liver, male tissue weights | No effect on androgen synthesis or activity | LOAEL = 50 (thyroid effects) NOAEL = 200 (male reproduction)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"200","page":75,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_173"} |
| Regulatory source |
- |
200 |
mg/kg bw/day |
rat |
oral |
31 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=200; DOSE=50, 100, 200 mg/kg bw/day n=6 | ↓ T3 and T4 at all doses ↔ TSH Histopathologic changes of thyroid ↑ Relative liver weight (%) at 200 ↑ hepatic enzymes (Ugt2b1, CYP2b1 at all doses, CYP1a1, CYP3a1 and Sult1c1 at 100 and 200, CYP1a2 at 200) | LOAEL= 50; EFFECT=Unlabeled table on page 78: Zhang et al. | 2018 | Male Sprague- Dawley rats | 31 days gavage exposure of 23 day old male rats Doses: 50, 100, 200 mg/kg bw/day n=6 | ↓ T3 and T4 at all doses ↔ TSH Histopathologic changes of thyroid ↑ Relative liver weight (%) at 200 ↑ hepatic enzymes (Ugt2b1, CYP2b1 at all doses, CYP1a1, CYP3a1 and Sult1c1 at 100 and 200, CYP1a2 at 200) | LOAEL= 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"50, 100, 200 mg/kg bw/day n=6 | ↓ T3 and T4 at all doses ↔ TSH Histopathologic changes of thyroid ↑ Relative liver weight (%) at 200 ↑ hepatic enzymes (Ugt2b1, CYP2b1 at all doses, CYP1a1, CYP3a1 and Sult1c1 at 100 and 200, CYP1a2 at 200) | LOAEL= 50","duration":"31 days","effect":"Unlabeled table on page 78: Zhang et al. | 2018 | Male Sprague- Dawley rats | 31 days gavage exposure of 23 day old male rats Doses: 50, 100, 200 mg/kg bw/day n=6 | ↓ T3 and T4 at all doses ↔ TSH Histopathologic changes of thyroid ↑ Relative liver weight (%) at 200 ↑ hepatic enzymes (Ugt2b1, CYP2b1 at all doses, CYP1a1, CYP3a1 and Sult1c1 at 100 and 200, CYP1a2 at 200) | LOAEL= 50","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":78,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_180"} |
| Regulatory source |
- |
300 |
mg/kg/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=300; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; LOAEL_VALUE=300 mg/kg/d; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________70 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Paul et al. 2012 Female Long- Evans Rats Oral gavage, GD6 - PND21 Doses: 10, 30, 100, 300 mg/kg/d Assigned to this order of doses n = 21, 12, 22, 22 + 11 animals/group for GD21 sacrifice ↓ T4 in GD20 dams at 300 ↓ T4 in PND22 dams at 100 and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight T4 reduct; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________70 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Paul et al. 2012 Female Long- Evans Rats Oral gavage, GD6 - PND21 Doses: 10, 30, 100, 300 mg/kg/d Assigned to this order of doses n = 21, 12, 22, 22 + 11 animals/group for GD21 sacrifice ↓ T4 in GD20 dams at 300 ↓ T4 in PND22 dams at 100 and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight T4 reduct","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"300 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"300","page":70,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_052"} |
| Regulatory source |
- |
300 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight T4 reductions with concomitant increased PROD and UGT activity suggest that up- regulated hepatic catabolism may contribute to triclosan-induced hypothyroxinemia during development. Exposure conveyed from dams to offspring diminishes over the lactation period. Dams: NOEL = 30 (PND22) BMDL = 25.2 (GD20); EFFECT=and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight T4 reductions with concomitant increased PROD and UGT activity suggest that up- regulated hepatic catabolism may contribute to triclosan-induced hypothyroxinemia during development. Exposure conveyed from dams to offspring diminishes over the lactation period. Dams: NOEL = 30 (PND22) BMDL = 25.2 (GD20); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight T4 reductions with concomitant increased PROD and UGT activity suggest that up- regulated hepatic catabolism may contribute to triclosan-induced hypothyroxinemia during development. Exposure conveyed from dams to offspring diminishes over the lactation period. Dams: NOEL = 30 (PND22) BMDL = 25.2 (GD20)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight T4 reductions with concomitant increased PROD and UGT activity suggest that up- regulated hepatic catabolism may contribute to triclosan-induced hypothyroxinemia during development. Exposure conveyed from dams to offspring diminishes over the lactation period. Dams: NOEL = 30 (PND22) BMDL = 25.2 (GD20)","page":70,"route":"","species":"","study_id":"sccs_o_265_noael_053"} |
| Regulatory source |
- |
300 |
mg/kg/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=300; DOSE=10, 30, 100, 300 mg/kg/d Assigned to this order of doses n = 21, 12, 22, 22 + 11 animals/group for GD21 sacrifice | ↓ T4 in GD20 dams at 300 ↓ T4 in PND22 dams at 100 and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cy...; EFFECT=Unlabeled table on page 70: Paul et al. | 2012 | Female Long- Evans Rats | Oral gavage, GD6 - PND21 Doses: 10, 30, 100, 300 mg/kg/d Assigned to this order of doses n = 21, 12, 22, 22 + 11 animals/group for GD21 sacrifice | ↓ T4 in GD20 dams at 300 ↓ T4 in PND22 dams at 100 and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight | T4 reductions with concomitant increased PROD and UGT activity suggest that up- regulated hepatic catabolism may contribute to triclosan-induced hypothyroxinemia during development. Exposure conveyed from dams to offspring diminishes over the lactation period. | Dams: NOEL = 30 (PND22) BMDL = 25.2 (GD20); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"10, 30, 100, 300 mg/kg/d Assigned to this order of doses n = 21, 12, 22, 22 + 11 animals/group for GD21 sacrifice | ↓ T4 in GD20 dams at 300 ↓ T4 in PND22 dams at 100 and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cy...","duration":"","effect":"Unlabeled table on page 70: Paul et al. | 2012 | Female Long- Evans Rats | Oral gavage, GD6 - PND21 Doses: 10, 30, 100, 300 mg/kg/d Assigned to this order of doses n = 21, 12, 22, 22 + 11 animals/group for GD21 sacrifice | ↓ T4 in GD20 dams at 300 ↓ T4 in PND22 dams at 100 and 300 ↓ T4 in GD20 and PND4 offspring at 300 ↔ T4 in PND14 and PND21 offspring ↑ hepatic PROD activity in PND4 pups and PND22 dams at 300 ↑ UGT activity in PND22 dams at 300 ↑ Cyp2b and Cyp3a expression in dams (minor) ↔ T3 and TSH ↔ dam liver weight | T4 reductions with concomitant increased PROD and UGT activity suggest that up- regulated hepatic catabolism may contribute to triclosan-induced hypothyroxinemia during development. Exposure conveyed from dams to offspring diminishes over the lactation period. | Dams: NOEL = 30 (PND22) BMDL = 25.2 (GD20)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg/d","noael_value":"300","page":70,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_160"} |
| Regulatory source |
- |
320 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=320; DOSE=_____ ___________________________________________________________________________________________79 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Mandal et al.; EFFECT=_____ ___________________________________________________________________________________________79 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Mandal et al. 2020 Male rats (Rattus norvegicus) Lactating mothers given oral doses from PND1-28 Doses: 3 and 5 mg/kg bw/day ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 NOAEL = 5 Raj et al. 2021 Male Swiss rats Adult rats given oral doses on 42 consecutive days Doses: 40, 80, 160 and 320 mg/kg bw/day N=12/group ↓ weights of epididymis and seminal vesicle at all doses ↓ spermatozoa count, percentage motile and viable spermatozoa at all doses Accumulation of triclosan in eoididymis and seminal vesicle at 320 LOAEL = 40; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"_____ ___________________________________________________________________________________________79 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Mandal et al.","duration":"","effect":"_____ ___________________________________________________________________________________________79 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Mandal et al. 2020 Male rats (Rattus norvegicus) Lactating mothers given oral doses from PND1-28 Doses: 3 and 5 mg/kg bw/day ↓ testis weight at 5 ↓ no. of OCT ¾ germ cells and mRNA levels at 3 and 5 ↓ no. of 3βHSD positive Leydig cells and mRNA levels at 3 and 5 ↓ no. of AR- positive germ cells and mRNA levels at 5 ↓ daily sperm production at 5 NOAEL = 5 Raj et al. 2021 Male Swiss rats Adult rats given oral doses on 42 consecutive days Doses: 40, 80, 160 and 320 mg/kg bw/day N=12/group ↓ weights of epididymis and seminal vesicle at all doses ↓ spermatozoa count, percentage motile and viable spermatozoa at all doses Accumulation of triclosan in eoididymis and seminal vesicle at 320 LOAEL = 40","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"320","page":79,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_070"} |
| Regulatory source |
- |
320 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=320; DOSE=40, 80, 160 and 320 mg/kg bw/day N=12/group | ↓ weights of epididymis and seminal vesicle at all doses ↓ spermatozoa count, percentage motile and viable spermatozoa at all doses Accumulation of triclosan in eoididymis and seminal vesicle at 320 | LOAEL = 40; EFFECT=Unlabeled table on page 79: Raj et al. | 2021 | Male Swiss rats | Adult rats given oral doses on 42 consecutive days Doses: 40, 80, 160 and 320 mg/kg bw/day N=12/group | ↓ weights of epididymis and seminal vesicle at all doses ↓ spermatozoa count, percentage motile and viable spermatozoa at all doses Accumulation of triclosan in eoididymis and seminal vesicle at 320 | LOAEL = 40; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"40, 80, 160 and 320 mg/kg bw/day N=12/group | ↓ weights of epididymis and seminal vesicle at all doses ↓ spermatozoa count, percentage motile and viable spermatozoa at all doses Accumulation of triclosan in eoididymis and seminal vesicle at 320 | LOAEL = 40","duration":"","effect":"Unlabeled table on page 79: Raj et al. | 2021 | Male Swiss rats | Adult rats given oral doses on 42 consecutive days Doses: 40, 80, 160 and 320 mg/kg bw/day N=12/group | ↓ weights of epididymis and seminal vesicle at all doses ↓ spermatozoa count, percentage motile and viable spermatozoa at all doses Accumulation of triclosan in eoididymis and seminal vesicle at 320 | LOAEL = 40","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"320","page":79,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_184"} |
| Regulatory source |
- |
450 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.; EFFECT=Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:Acceptable daily intake; AGD: Anogenital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.","page":80,"route":"","species":"human","study_id":"sccs_o_265_noael_074"} |
| Regulatory source |
- |
450 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:genital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.; EFFECT=genital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"genital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:genital distance; AR: Androgen receptor; BMD: Bencjmark dose: BMDL: Lower bound of the BMD confidence interval; Cyp: Cytochorme P450 ; EE: 17α-Ethinylestradiol; FSH: Follicle-stimulating hormone; GD: Gestational day; Gnrh:Gonadotropinn-releasing hormone ; hCG: Human chorionic gonadotropin; H&E: Hematoxylin and eosin; HSD: Hydroxysteroid dehydrogenase; LH: Luteinising hormone; LHR: Luteinising hormone receptor; LOAEL: Lowest observed adverse effect level; miR: MicroRNA gene; NOAEL: No observed adverse effect level; NOEL: No observed effect level; PND: Postnatal day; PPAR: Peroxisome proliferator- activated receptor; PROD: Pentoxyresorufin O-dealkylase; RXR: Retinoid X receptor; SRB: Scavenger receptor type B; StAR: Steroidogenic acute regulatory protein; Sult: Sulfotransferase; T3: Triiodothyronine; T4: Thyroxine ; TSH: Thyroid-stimulating hormone; UGT: Uridine 5'-diphospho-glucuronosyltransferase.","page":80,"route":"","species":"human","study_id":"sccs_o_265_noael_075"} |
| Regulatory source |
- |
600 |
mg/kg bw/d |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=600; DOSE=30, 100, 300 and 600 mg/kg bw/d | ↓ uterine weight at 600 ↓ progesterone at all doses ↓ estradiol, | No investigations of effects in pups | LOAEL = 30 (progesterone); EFFECT=Unlabeled table on page 71: Feng et al. | 2016 | Female Sprague- Dawley rats | Exposure of pregnant rat dams from GD6 to GD20 Doses: 30, 100, 300 and 600 mg/kg bw/d | ↓ uterine weight at 600 ↓ progesterone at all doses ↓ estradiol, | No investigations of effects in pups | LOAEL = 30 (progesterone); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"30, 100, 300 and 600 mg/kg bw/d | ↓ uterine weight at 600 ↓ progesterone at all doses ↓ estradiol, | No investigations of effects in pups | LOAEL = 30 (progesterone)","duration":"","effect":"Unlabeled table on page 71: Feng et al. | 2016 | Female Sprague- Dawley rats | Exposure of pregnant rat dams from GD6 to GD20 Doses: 30, 100, 300 and 600 mg/kg bw/d | ↓ uterine weight at 600 ↓ progesterone at all doses ↓ estradiol, | No investigations of effects in pups | LOAEL = 30 (progesterone)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"600","page":71,"route":"","species":"rat","study_id":"sccs_o_265_noael_164"} |
| Regulatory source |
- |
750 |
mg/kg bw/d |
rat |
oral |
12 week |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=750; DOSE=EL (mg/kg bw/d) Cao et al.; EFFECT=EL (mg/kg bw/d) Cao et al. 2018 Female ICR mice 12 week old female mice exposed for 50 days Doses: 1, 10, 100 mg/kg/d ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus Levothyroxine rescues estrous cycling, follicular development and ovulation NOAEL = 1 Ena et al. 2018 Male Sprague- Dawley rats 60-day oral gavage exposure of prepubertal male rats Doses: 0.25, 25, 250 and 750 mg/kg bw/d n = 6 ↓ weight of liver, kidney, testes, adrenal glands at 750 ↑ CYP2B1, RXR/PPAR, malondialdehyde at 250-750 LOAEL = 250 (sperm production); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"EL (mg/kg bw/d) Cao et al.","duration":"12 week","effect":"EL (mg/kg bw/d) Cao et al. 2018 Female ICR mice 12 week old female mice exposed for 50 days Doses: 1, 10, 100 mg/kg/d ↓ T3, T4 at 10 and 100 ↑ TSH, TRH at 10 and 100 ↓ FSH, LH, progesteron, Gnrh mRNA with the lack of LH-surge and ↑ prolactin ↑ length off estrous cycle and diestrus at 10 and 100 ↓ number of antral follicles and corpora lutea at 10 and 100 ↓ kisspeptin immunoreactivity and kiss1 mRNA in anteroventral periventricular nucleus Levothyroxine rescues estrous cycling, follicular development and ovulation NOAEL = 1 Ena et al. 2018 Male Sprague- Dawley rats 60-day oral gavage exposure of prepubertal male rats Doses: 0.25, 25, 250 and 750 mg/kg bw/d n = 6 ↓ weight of liver, kidney, testes, adrenal glands at 750 ↑ CYP2B1, RXR/PPAR, malondialdehyde at 250-750 LOAEL = 250 (sperm production)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"750","page":74,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_061"} |
| Regulatory source |
- |
750 |
mg/kg bw/d |
rat |
oral |
60-day |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=750; DOSE=0.25, 25, 250 and 750 mg/kg bw/d n = 6 | ↓ weight of liver, kidney, testes, adrenal glands at 750 ↑ CYP2B1, RXR/PPAR, malondialdehyde at 250-750 | LOAEL = 250 (sperm production); EFFECT=Unlabeled table on page 74: Ena et al. | 2018 | Male Sprague- Dawley rats | 60-day oral gavage exposure of prepubertal male rats Doses: 0.25, 25, 250 and 750 mg/kg bw/d n = 6 | ↓ weight of liver, kidney, testes, adrenal glands at 750 ↑ CYP2B1, RXR/PPAR, malondialdehyde at 250-750 | LOAEL = 250 (sperm production); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0.25, 25, 250 and 750 mg/kg bw/d n = 6 | ↓ weight of liver, kidney, testes, adrenal glands at 750 ↑ CYP2B1, RXR/PPAR, malondialdehyde at 250-750 | LOAEL = 250 (sperm production)","duration":"60-day","effect":"Unlabeled table on page 74: Ena et al. | 2018 | Male Sprague- Dawley rats | 60-day oral gavage exposure of prepubertal male rats Doses: 0.25, 25, 250 and 750 mg/kg bw/d n = 6 | ↓ weight of liver, kidney, testes, adrenal glands at 750 ↑ CYP2B1, RXR/PPAR, malondialdehyde at 250-750 | LOAEL = 250 (sperm production)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"750","page":74,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_171"} |
| Regulatory source |
- |
>1000 |
mg/kg bw |
rat |
oral |
5 days |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=> 1000; DOSE=t 0 (controls), 500 or 1000 mg/kg bw by intubation 5 days a week during 30 days (Monsanto, 1960).; EFFECT=t 0 (controls), 500 or 1000 mg/kg bw by intubation 5 days a week during 30 days (Monsanto, 1960). Food consumption and body weights were recorded weekly and observations were made for signs of toxicity. After 30 days, representative animals from each group were sacrificed for necropsy. The viscera of the 1000 mg/kg bw and control groups were examined microscopically. The viscera of the 500 mg/kg bw group were held for potential further examination. Based on food consumption, growth data and tissue examination, the NOAEL was determined to be > 1000 mg/kg bw. The study was not conducted in compliance with GLP regulations, but met generally accepted scientific standards. Ref.: 19 Triclocarban (purity 98.6%) was administered to three groups of 35 Sprague-Dawley rats in their diet at concentrations equivalent to 25, 75 and 250 mg/kg bw/d for 8 weeks (Monsanto, 1985). No control group was included in the study. Animals were observed twice daily for morbidity and mortality and once daily for clinical signs. Body weight, food consumpti; CITATION=Ref.: 19 Triclocarban (purity 98; CITATION_NUMBERS=[19,98]; REFERENCE=Ref.: 19 Triclocarban (purity 98; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 19 Triclocarban (purity 98","dose":"t 0 (controls), 500 or 1000 mg/kg bw by intubation 5 days a week during 30 days (Monsanto, 1960).","duration":"5 days","effect":"t 0 (controls), 500 or 1000 mg/kg bw by intubation 5 days a week during 30 days (Monsanto, 1960). Food consumption and body weights were recorded weekly and observations were made for signs of toxicity. After 30 days, representative animals from each group were sacrificed for necropsy. The viscera of the 1000 mg/kg bw and control groups were examined microscopically. The viscera of the 500 mg/kg bw group were held for potential further examination. Based on food consumption, growth data and tissue examination, the NOAEL was determined to be > 1000 mg/kg bw. The study was not conducted in compliance with GLP regulations, but met generally accepted scientific standards. Ref.: 19 Triclocarban (purity 98.6%) was administered to three groups of 35 Sprague-Dawley rats in their diet at concentrations equivalent to 25, 75 and 250 mg/kg bw/d for 8 weeks (Monsanto, 1985). No control group was included in the study. Animals were observed twice daily for morbidity and mortality and once daily for clinical signs. Body weight, food consumpti","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 1000","page":20,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_005"} |
| Regulatory source |
- |
1643 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:CS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 57 Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure scenarios Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Deodorant Children 3-10 0.3 0.00392 8 2 041 Adolescents 10-14 0.3 0.00312 8 2 564 Adolescents 14-18 0.3 0.00288 8 2 778 Body lotion Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8 13 Children 3-10 0.3 0.48462 8 17 Adolescents 10-14 0.3 0.38508 8 21 Adolescents 14-18 0.3 0.35669 8 22 Face powder Adolescents 14-18 0.3 0.00564 8 1 418 Blemish concealer Adolescents 14-18 0.3 0.00057 8 14 035 Aggregated exposure Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8; DOSE=MoS calculation for triclosan in leave-on products by age categories and exposure scenarios Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Deodorant Children 3-10 0.3 0.00392 8 2 041 Adolescents 10-14 0.3 0.00312 8 2 564 Adolescents 14-18 0.3 0.00288 8 2 778 Body lotion Infants 0.5-1 0.3 0.64255 8 12 T...; EFFECT=CS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 57 Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure scenarios Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Deodorant Children 3-10 0.3 0.00392 8 2 041 Adolescents 10-14 0.3 0.00312 8 2 564 Adolescents 14-18 0.3 0.00288 8 2 778 Body lotion Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8 13 Children 3-10 0.3 0.48462 8 17 Adolescents 10-14 0.3 0.38508 8 21 Adolescents 14-18 0.3 0.35669 8 22 Face powder Adolescents 14-18 0.3 0.00564 8 1 418 Blemish concealer Adolescents 14-18 0.3 0.00057 8 14 035 Aggregated exposure Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"MoS calculation for triclosan in leave-on products by age categories and exposure scenarios Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Deodorant Children 3-10 0.3 0.00392 8 2 041 Adolescents 10-14 0.3 0.00312 8 2 564 Adolescents 14-18 0.3 0.00288 8 2 778 Body lotion Infants 0.5-1 0.3 0.64255 8 12 T...","duration":"","effect":"CS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 57 Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure scenarios Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Deodorant Children 3-10 0.3 0.00392 8 2 041 Adolescents 10-14 0.3 0.00312 8 2 564 Adolescents 14-18 0.3 0.00288 8 2 778 Body lotion Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8 13 Children 3-10 0.3 0.48462 8 17 Adolescents 10-14 0.3 0.38508 8 21 Adolescents 14-18 0.3 0.35669 8 22 Face powder Adolescents 14-18 0.3 0.00564 8 1 418 Blemish concealer Adolescents 14-18 0.3 0.00057 8 14 035 Aggregated exposure Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:CS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 57 Table 26. MoS calculation for triclosan in leave-on products by age categories and exposure scenarios Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Deodorant Children 3-10 0.3 0.00392 8 2 041 Adolescents 10-14 0.3 0.00312 8 2 564 Adolescents 14-18 0.3 0.00288 8 2 778 Body lotion Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8 13 Children 3-10 0.3 0.48462 8 17 Adolescents 10-14 0.3 0.38508 8 21 Adolescents 14-18 0.3 0.35669 8 22 Face powder Adolescents 14-18 0.3 0.00564 8 1 418 Blemish concealer Adolescents 14-18 0.3 0.00057 8 14 035 Aggregated exposure Infants 0.5-1 0.3 0.64255 8 12 Toddler 1-3 0.3 0.60545 8","page":57,"route":"","species":"","study_id":"sccs_o_265_noael_045"} |
| Regulatory source |
- |
1643 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 58 Table 27. SED Calculation for triclosan in rinse-off products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Shower gel Infants 0.5-1 0.03 0.03289 8 243 Toddler 1-3 0.03 0.03096 8 258 Children 3-10 0.03 0.02477 8 323 Adolescents 10-14 0.03 0.01970 8 406 Adolescents 14-18 0.03 0.01824 8 439 Hand soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Ado; DOSE=SED Calculation for triclosan in rinse-off products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Shower gel Infants 0.5-1 0.03 0.03289 8 243 Toddler 1-3 0.03 0.03096 8 258 Children 3-10 0.03 0.02477 8 323 Adolescents 10-14 0.03 0.01970 8 406 Adolescents 14-18 0.03 0.01824 8 439 Hand...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 58 Table 27. SED Calculation for triclosan in rinse-off products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Shower gel Infants 0.5-1 0.03 0.03289 8 243 Toddler 1-3 0.03 0.03096 8 258 Children 3-10 0.03 0.02477 8 323 Adolescents 10-14 0.03 0.01970 8 406 Adolescents 14-18 0.03 0.01824 8 439 Hand soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Ado; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SED Calculation for triclosan in rinse-off products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Shower gel Infants 0.5-1 0.03 0.03289 8 243 Toddler 1-3 0.03 0.03096 8 258 Children 3-10 0.03 0.02477 8 323 Adolescents 10-14 0.03 0.01970 8 406 Adolescents 14-18 0.03 0.01824 8 439 Hand...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 58 Table 27. SED Calculation for triclosan in rinse-off products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Shower gel Infants 0.5-1 0.03 0.03289 8 243 Toddler 1-3 0.03 0.03096 8 258 Children 3-10 0.03 0.02477 8 323 Adolescents 10-14 0.03 0.01970 8 406 Adolescents 14-18 0.03 0.01824 8 439 Hand soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Ado","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 58 Table 27. SED Calculation for triclosan in rinse-off products by age categories Age category Age (yrs) Triclosan content (%) SEDdermal (mg/kg bw/d) NOAEL (mg/kg bw/d) MoS Shower gel Infants 0.5-1 0.03 0.03289 8 243 Toddler 1-3 0.03 0.03096 8 258 Children 3-10 0.03 0.02477 8 323 Adolescents 10-14 0.03 0.01970 8 406 Adolescents 14-18 0.03 0.01824 8 439 Hand soap Infants 0.5-1 0.03 0.01131 8 707 Toddler 1-3 0.03 0.01064 8 752 Children 3-10 0.03 0.00852 8 939 Adolescents 10-14 0.03 0.00677 8 1 182 Adolescents 14-18 0.03 0.00627 8 1 276 Aggregated exposure Infants 0.5-1 0.03 0.04420 8 181 Toddler 1-3 0.03 0.04160 8 192 Children 3-10 0.03 0.03329 8 240 Ado","page":58,"route":"","species":"","study_id":"sccs_o_265_noael_046"} |
| Regulatory source |
- |
1643 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________72 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) n = 10, n=6 in most assays prolactin at 100- 600 ↓ testosterone at 300-600 ↓ hCG at all doses (flat response) ↔ LH, FSH ↑ mRNA of placental steroid metabolising enzymes: UGT1A1, Sult1E1, steroid 5alphareductase 1 and 2 at 100-300 (600 not tested) ↑progesterone receptor, estrogen receptor-alpha and androgen- receptor at 100- 300 (600 not tested); DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________72 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) n = 10, n=6 in most assays prolactin at 100- 600 ↓ testosterone at 300-600 ↓ hCG at all doses (flat response) ↔ LH, FSH ↑ mRNA of placental steroid metabolising enzymes: UGT1A1, Sult1E1, steroid 5alphareductase 1 and 2 at 100-300 (600 not tested) ↑progesterone receptor, estrogen receptor-alpha and androgen- receptor at 100- 300 (600 not tested); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________72 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) n = 10, n=6 in most assays prolactin at 100- 600 ↓ testosterone at 300-600 ↓ hCG at all doses (flat response) ↔ LH, FSH ↑ mRNA of placental steroid metabolising enzymes: UGT1A1, Sult1E1, steroid 5alphareductase 1 and 2 at 100-300 (600 not tested) ↑progesterone receptor, estrogen receptor-alpha and androgen- receptor at 100- 300 (600 not tested)","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________72 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) n = 10, n=6 in most assays prolactin at 100- 600 ↓ testosterone at 300-600 ↓ hCG at all doses (flat response) ↔ LH, FSH ↑ mRNA of placental steroid metabolising enzymes: UGT1A1, Sult1E1, steroid 5alphareductase 1 and 2 at 100-300 (600 not tested) ↑progesterone receptor, estrogen receptor-alpha and androgen- receptor at 100- 300 (600 not tested)","page":72,"route":"","species":"","study_id":"sccs_o_265_noael_056"} |
| Regulatory source |
- |
4000 |
mg/kg bw/day |
mouse |
oral |
14 days |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=4000; DOSE=1000, 2000 and 4000 mg/kg bw/day n=8 | ↓ total distance movement, grip strength at 4000 ↓ open arms spent time, central to peripheral zone spent time, closed arms entry, latency to fall at all doses Adverse H&E stain on brain | Very high doses tested | LOAEL = 1000; EFFECT=Unlabeled table on page 78: Tabari et al. | 2019 | Adult NMRI mice | Adult male NMRI mice given oral gavage for 14 days Doses: 1000, 2000 and 4000 mg/kg bw/day n=8 | ↓ total distance movement, grip strength at 4000 ↓ open arms spent time, central to peripheral zone spent time, closed arms entry, latency to fall at all doses Adverse H&E stain on brain | Very high doses tested | LOAEL = 1000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"1000, 2000 and 4000 mg/kg bw/day n=8 | ↓ total distance movement, grip strength at 4000 ↓ open arms spent time, central to peripheral zone spent time, closed arms entry, latency to fall at all doses Adverse H&E stain on brain | Very high doses tested | LOAEL = 1000","duration":"14 days","effect":"Unlabeled table on page 78: Tabari et al. | 2019 | Adult NMRI mice | Adult male NMRI mice given oral gavage for 14 days Doses: 1000, 2000 and 4000 mg/kg bw/day n=8 | ↓ total distance movement, grip strength at 4000 ↓ open arms spent time, central to peripheral zone spent time, closed arms entry, latency to fall at all doses Adverse H&E stain on brain | Very high doses tested | LOAEL = 1000","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4000","page":78,"route":"oral","species":"mouse","study_id":"sccs_o_265_noael_181"} |
| Regulatory source |
- |
6750 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6750; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Infants | 0.5 -1 | 55.09 | 17.73 | 45.45 | 118.27 | 6750 | 57; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Infants | 0.5 -1 | 55.09 | 17.73 | 45.45 | 118.27 | 6750 | 57","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"6750","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_077"} |
| Regulatory source |
- |
6750 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6750; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Toddlers | 1-3 | 51.76 | 17.14 | 33.61 | 102.51 | 6750 | 66; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Toddlers | 1-3 | 51.76 | 17.14 | 33.61 | 102.51 | 6750 | 66","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"6750","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_078"} |
| Regulatory source |
- |
6750 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6750; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Children | 3-6 | 48.07 | 13.51 | 17.32 | 78.90 | 6750 | 86; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Children | 3-6 | 48.07 | 13.51 | 17.32 | 78.90 | 6750 | 86","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"6750","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_079"} |
| Regulatory source |
- |
6750 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6750; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Children | 6-10 | 48.07 | 13.51 | 17.32 | 78.90 | 6750 | 86; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Children | 6-10 | 48.07 | 13.51 | 17.32 | 78.90 | 6750 | 86","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"6750","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_080"} |
| Regulatory source |
- |
6750 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6750; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Adolescents | 10-14 | 41.59 | 11.06 | 6.34 | 58.99 | 6750 | 114; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Adolescents | 10-14 | 41.59 | 11.06 | 6.34 | 58.99 | 6750 | 114","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"6750","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_081"} |
| Regulatory source |
- |
6750 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=6750; EFFECT=Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Adolescents | 14-18 | 38.86 | 10.18 | 4.49 | 53.53 | 6750 | 126; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 24. MoS calculations for triclocarban by age categories when used as a preservative: Adolescents | 14-18 | 38.86 | 10.18 | 4.49 | 53.53 | 6750 | 126","endpoint":"","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"6750","page":55,"route":"","species":"","study_id":"sccs_o_265_noael_082"} |
| Regulatory source |
- |
10000 |
ppm |
rat |
- |
Chronic |
- |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=10000; DOSE=Rat | Chronic toxicity | 1000, 3000, 10000 ppm | Insufficient study information to establish a NOEL; EFFECT=Unlabeled table on page 20: Rat | Chronic toxicity | 1000, 3000, 10000 ppm | Insufficient study information to establish a NOEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Rat | Chronic toxicity | 1000, 3000, 10000 ppm | Insufficient study information to establish a NOEL","duration":"Chronic","effect":"Unlabeled table on page 20: Rat | Chronic toxicity | 1000, 3000, 10000 ppm | Insufficient study information to establish a NOEL","endpoint":"","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"10000","page":20,"route":"","species":"rat","study_id":"sccp_o_016_noael_027"} |
| Regulatory source |
carcinogenicity |
10000 |
ppm |
rat |
oral |
6 months |
carcinogenicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=10000; DOSE=No testicular lesions were present in rats fed 1000 ppm (approximately 100mg/kg/day).; EFFECT=ia after 6 months of exposure. No testicular lesions were present in rats fed 1000 ppm (approximately 100mg/kg/day). No other gross, biochemical, haematological, central nervous system or histopathological effects related to Triclocarban were observed in the course of this study. It was concluded that Triclocarban was not carcinogenic in rats that were fed with a diet containing 10000 ppm Triclocarban for 24 months. There was not enough information available to evaluate the quality of the study, nor to establish a NOEL. Ref.: 44 3.3.6. Mutagenicity / Genotoxicity Table 6: Summary of available genotoxicity data Study type Test system Endpoint Result References Ames test S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 Mutagenicity Not mutagenic with or without metabolic activation Bayer AG, 1992c Ref.: 4 Ames test S. typhimurium strains TA 98, TA 100, TA 1537 and TA 1538 Mutagenicity Not mutagenic with or without metabolic activation Bonin et al., 1982 Ref.: 7 Chromosomal aberration test Chinese hamster ovary cells (C; CITATION=Ref.: 44 3; CITATION_NUMBERS=[44,3]; REFERENCE=Ref.: 44 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 44 3","dose":"No testicular lesions were present in rats fed 1000 ppm (approximately 100mg/kg/day).","duration":"6 months","effect":"ia after 6 months of exposure. No testicular lesions were present in rats fed 1000 ppm (approximately 100mg/kg/day). No other gross, biochemical, haematological, central nervous system or histopathological effects related to Triclocarban were observed in the course of this study. It was concluded that Triclocarban was not carcinogenic in rats that were fed with a diet containing 10000 ppm Triclocarban for 24 months. There was not enough information available to evaluate the quality of the study, nor to establish a NOEL. Ref.: 44 3.3.6. Mutagenicity / Genotoxicity Table 6: Summary of available genotoxicity data Study type Test system Endpoint Result References Ames test S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 Mutagenicity Not mutagenic with or without metabolic activation Bayer AG, 1992c Ref.: 4 Ames test S. typhimurium strains TA 98, TA 100, TA 1537 and TA 1538 Mutagenicity Not mutagenic with or without metabolic activation Bonin et al., 1982 Ref.: 7 Chromosomal aberration test Chinese hamster ovary cells (C","endpoint":"carcinogenicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"10000","page":21,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_008"} |
| Regulatory source |
developmental toxicity |
65 |
% |
rat |
oral |
90 days |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=65; DOSE=SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 26 mg/kg/day orally for 90 days, in rabbits treated dermally with 40 mg/kg/day for 90 days, or in mice treated dermally with 600 mg/kg on alternate days for 18 months.; EFFECT=SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 26 mg/kg/day orally for 90 days, in rabbits treated dermally with 40 mg/kg/day for 90 days, or in mice treated dermally with 600 mg/kg on alternate days for 18 months. Triclocarban showed no evidence of teratogenic or feticidal activity. There was no evidence of teratogenicity. There was not enough information available to evaluate the quality of the study, nor to establish a NOEL. Ref.: 44 3.3.9. Toxicokinetics Animals The absorption, distribution and excretion of Triclocarban was evaluated in rats given a single oral, intravenous or dermal dose of 14C-labeled Triclocarban. With each route of administration more than 65% of the absorbed radioactivity was eliminated in the bile during the first 72h after dosing. The amount of Triclocarban in the organs was distributed as follows at 72h: highest content in the liver then kidneys and then lungs and testes. The investigators concluded that; CITATION=Ref.: 44 3; CITATION_NUMBERS=[44,3]; REFERENCE=Ref.: 44 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 44 3","dose":"SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 26 mg/kg/day orally for 90 days, in rabbits treated dermally with 40 mg/kg/day for 90 days, or in mice treated dermally with 600 mg/kg on alternate days for 18 months.","duration":"90 days","effect":"SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 26 mg/kg/day orally for 90 days, in rabbits treated dermally with 40 mg/kg/day for 90 days, or in mice treated dermally with 600 mg/kg on alternate days for 18 months. Triclocarban showed no evidence of teratogenic or feticidal activity. There was no evidence of teratogenicity. There was not enough information available to evaluate the quality of the study, nor to establish a NOEL. Ref.: 44 3.3.9. Toxicokinetics Animals The absorption, distribution and excretion of Triclocarban was evaluated in rats given a single oral, intravenous or dermal dose of 14C-labeled Triclocarban. With each route of administration more than 65% of the absorbed radioactivity was eliminated in the bile during the first 72h after dosing. The amount of Triclocarban in the organs was distributed as follows at 72h: highest content in the liver then kidneys and then lungs and testes. The investigators concluded that","endpoint":"developmental toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"%","noael_value":"65","page":26,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_014"} |
| Regulatory source |
genotoxicity |
6 |
- |
- |
- |
- |
genotoxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=unclear:Table 6: Summary of available genotoxicity data: t | o evaluate the q | uality | of the stu | dy, nor to es | tablish a | NOEL.; EFFECT=Table 6: Summary of available genotoxicity data: t | o evaluate the q | uality | of the stu | dy, nor to es | tablish a | NOEL.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"","effect":"Table 6: Summary of available genotoxicity data: t | o evaluate the q | uality | of the stu | dy, nor to es | tablish a | NOEL.","endpoint":"genotoxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"","noael_value":"unclear:Table 6: Summary of available genotoxicity data: t | o evaluate the q | uality | of the stu | dy, nor to es | tablish a | NOEL.","page":21,"route":"","species":"","study_id":"sccp_o_016_noael_028"} |
| Regulatory source |
irritation |
12 |
mg/kg bw/day |
rat |
oral |
- |
irritation |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=12; DOSE=Triclosan is not acutely toxic via the oral route of administration (LD50 > 5 000 mg/kg body weight in dogs).; EFFECT=not provide robust evidence of endocrine disruptive effects of triclocarban. Triclosan Triclosan at a concentration of 0.3% is not a skin or oral mucosal irritant, whereas at 1 to 10% concentrations it produced slight, reversible irritation in the rabbit eye. Triclosan has a low sensitisation potential in humans. Possible photocontact allergy has been rarely reported. Triclosan is not acutely toxic via the oral route of administration (LD50 > 5 000 mg/kg body weight in dogs). Four rat studies give evidence for a NOAEL between 8 and 12 mg/kg bw/day (Lan, 2015; Montagnini 2018, 2021; Pernoncini 2018). Since Montagnini et al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well-performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Triclosan is not acutely toxic via the oral route of administration (LD50 > 5 000 mg/kg body weight in dogs).","duration":"","effect":"not provide robust evidence of endocrine disruptive effects of triclocarban. Triclosan Triclosan at a concentration of 0.3% is not a skin or oral mucosal irritant, whereas at 1 to 10% concentrations it produced slight, reversible irritation in the rabbit eye. Triclosan has a low sensitisation potential in humans. Possible photocontact allergy has been rarely reported. Triclosan is not acutely toxic via the oral route of administration (LD50 > 5 000 mg/kg body weight in dogs). Four rat studies give evidence for a NOAEL between 8 and 12 mg/kg bw/day (Lan, 2015; Montagnini 2018, 2021; Pernoncini 2018). Since Montagnini et al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well-performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and","endpoint":"irritation","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12","page":59,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_049"} |
| Regulatory source |
repeated dose toxicity |
1.5 |
% |
human |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=1.5; DOSE=The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d.; EFFECT=ios and dermal exposure occurring to the face, hands and the whole body during the cleansing process was the major route of exposure. The toxicological profile of Triclocarban indicates that the material has a low order of toxicity, based on a variety of acute, subchronic and chronic toxicity studies. It was neither genotoxic in examined in vitro systems, nor did it cause carcinogenic or reproductive/ developmental effects in in vivo animal studies. The risk to human health was characterised by dividing the lowest NOEL derived from animal toxicity studies by the estimated maximum systemic exposure. The quotient is generally referred to as the Margin of Safety (i.e., MOS). The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d. Dividing the internal NOEL of Triclocarban of 6.75 mg/kg bw/d (25 mg/kg bw/d derived from a 2-year chronic feeding study and corrected for an oral bioavaila; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d.","duration":"subchronic","effect":"ios and dermal exposure occurring to the face, hands and the whole body during the cleansing process was the major route of exposure. The toxicological profile of Triclocarban indicates that the material has a low order of toxicity, based on a variety of acute, subchronic and chronic toxicity studies. It was neither genotoxic in examined in vitro systems, nor did it cause carcinogenic or reproductive/ developmental effects in in vivo animal studies. The risk to human health was characterised by dividing the lowest NOEL derived from animal toxicity studies by the estimated maximum systemic exposure. The quotient is generally referred to as the Margin of Safety (i.e., MOS). The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d. Dividing the internal NOEL of Triclocarban of 6.75 mg/kg bw/d (25 mg/kg bw/d derived from a 2-year chronic feeding study and corrected for an oral bioavaila","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"%","noael_value":"1.5","page":36,"route":"oral","species":"human","study_id":"sccp_o_016_noael_025"} |
| Regulatory source |
repeated dose toxicity |
8 |
mg/kg bw/day |
rat |
- |
20-day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=__ 31 The four remaining rat studies, as well as the key study identified in SCCP (2009), provide evidence for a NOAEL between 8 and 12 mg/kg bw/day and a LOAEL of 40 mg/kg bw/day.; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=__ 31 The four remaining rat studies, as well as the key study identified in SCCP (2009), provide evidence for a NOAEL between 8 and 12 mg/kg bw/day and a LOAEL of 40 mg/kg bw/day. Since Montagnini et al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD based on NOAEL of 8 mg/kg bw/day. 3.4.3.8 Endocrine activity of triclosan: Human data In 2009, the SCCP (SCCP/1192/08) evaluated data from five clinical studies and concluded tha; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"__ 31 The four remaining rat studies, as well as the key study identified in SCCP (2009), provide evidence for a NOAEL between 8 and 12 mg/kg bw/day and a LOAEL of 40 mg/kg bw/day.","duration":"20-day","effect":"__ 31 The four remaining rat studies, as well as the key study identified in SCCP (2009), provide evidence for a NOAEL between 8 and 12 mg/kg bw/day and a LOAEL of 40 mg/kg bw/day. Since Montagnini et al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD based on NOAEL of 8 mg/kg bw/day. 3.4.3.8 Endocrine activity of triclosan: Human data In 2009, the SCCP (SCCP/1192/08) evaluated data from five clinical studies and concluded tha","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"8","page":31,"route":"","species":"rat","study_id":"sccs_o_265_noael_033"} |
| Regulatory source |
repeated dose toxicity |
8 |
mg/kg bw/day |
rat |
- |
20-day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan.; EFFECT=standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD based on NOAEL of 8 mg/kg bw/day. 3.4.3.8 Endocrine activity of triclosan: Human data In 2009, the SCCP (SCCP/1192/08) evaluated data from five clinical studies and concluded that these studies showed no signs of overt toxicity in humans. In addition, based on consumer use information for triclosan-containing toothpaste, data indicate that triclosan can be used safely and with good tolerability at levels that also are found in personal care products. Ref.: SCCP 2009 An overview on endocrine-related effects in human studies fo; CITATION=Ref.: SCCP 2009 An overview on endocrine-related effects in human studies fo; CITATION_NUMBERS=[2009]; REFERENCE=Ref.: SCCP 2009 An overview on endocrine-related effects in human studies fo; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: SCCP 2009 An overview on endocrine-related effects in human studies fo","dose":"standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan.","duration":"20-day","effect":"standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD based on NOAEL of 8 mg/kg bw/day. 3.4.3.8 Endocrine activity of triclosan: Human data In 2009, the SCCP (SCCP/1192/08) evaluated data from five clinical studies and concluded that these studies showed no signs of overt toxicity in humans. In addition, based on consumer use information for triclosan-containing toothpaste, data indicate that triclosan can be used safely and with good tolerability at levels that also are found in personal care products. Ref.: SCCP 2009 An overview on endocrine-related effects in human studies fo","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"8","page":31,"route":"","species":"rat","study_id":"sccs_o_265_noael_035"} |
| Regulatory source |
repeated dose toxicity |
9.375 |
mg/kg bw/day |
rat |
- |
20-day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=9.375; DOSE=(2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan.; EFFECT=al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD based on NOAEL of 8 mg/kg bw/day. 3.4.3.8 Endocrine activity of triclosan: Human data In 2009, the SCCP (SCCP/1192/08) evaluated data from five clinical studies and concluded that these studies showed no signs of overt toxicity in humans. In addition, based on consumer use information for triclosan-containing toothpaste, data indicate that triclosan can be used safely and wi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"(2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan.","duration":"20-day","effect":"al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD based on NOAEL of 8 mg/kg bw/day. 3.4.3.8 Endocrine activity of triclosan: Human data In 2009, the SCCP (SCCP/1192/08) evaluated data from five clinical studies and concluded that these studies showed no signs of overt toxicity in humans. In addition, based on consumer use information for triclosan-containing toothpaste, data indicate that triclosan can be used safely and wi","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"9.375","page":31,"route":"","species":"rat","study_id":"sccs_o_265_noael_034"} |
| Regulatory source |
repeated dose toxicity |
9.375 |
mg/kg bw/day |
rat |
- |
20-day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=9.375; DOSE=ine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 60 Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD of 8 mg/kg bw/day to...; EFFECT=ine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 60 Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD of 8 mg/kg bw/day. Triclosan was not found to be mutagenic or carcinogenic. However, it should be noted that triclosan is a peroxisome proliferator in mice liver. Several studies have demonstrated estrogenic and an anti-androgenic activity of triclosan, through both direct and indirect MoA, confirming the androgen- and estrogen-mediated activity of triclosan. There is also e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"ine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 60 Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD of 8 mg/kg bw/day to...","duration":"20-day","effect":"ine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 60 Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study and an uterotrophic assay in rats (Stoker et al. 2010), where the authors derived a NOEL of 9.375 mg/kg bw/day and LOEL of 18.75 mg/kg bw/day based on reduction in T4 and estradiol serum levels, provide further support for a PoD of 8 mg/kg bw/day. Triclosan was not found to be mutagenic or carcinogenic. However, it should be noted that triclosan is a peroxisome proliferator in mice liver. Several studies have demonstrated estrogenic and an anti-androgenic activity of triclosan, through both direct and indirect MoA, confirming the androgen- and estrogen-mediated activity of triclosan. There is also e","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"9.375","page":60,"route":"","species":"rat","study_id":"sccs_o_265_noael_050"} |
| Regulatory source |
repeated dose toxicity |
12 |
mg/kg bw/d |
rat |
oral |
13-week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=12; DOSE=The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day.; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=g bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day. Reproductive / developmental toxicity The SCCP (2009) derived a NOAEL of 65 mg/kg bw/d based on decreases in foetal body weights and the mean number of live pups reported in previous reproductive toxicity studies in the rat. Mutagenicity / genotoxicity Triclosan can be considered to have no relevant genotoxic potential in vivo. Carcinogenicity Triclosan is not classified as c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day.","duration":"13-week","effect":"g bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day. Reproductive / developmental toxicity The SCCP (2009) derived a NOAEL of 65 mg/kg bw/d based on decreases in foetal body weights and the mean number of live pups reported in previous reproductive toxicity studies in the rat. Mutagenicity / genotoxicity Triclosan can be considered to have no relevant genotoxic potential in vivo. Carcinogenicity Triclosan is not classified as c","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/d","noael_value":"12","page":16,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_012"} |
| Regulatory source |
repeated dose toxicity |
12 |
mg/kg bw/day |
rat |
- |
20-day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=12; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________...; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 31 The four remaining rat studies, as well as the key study identified in SCCP (2009), provide evidence for a NOAEL between 8 and 12 mg/kg bw/day and a LOAEL of 40 mg/kg bw/day. Since Montagnini et al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study an; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________...","duration":"20-day","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 31 The four remaining rat studies, as well as the key study identified in SCCP (2009), provide evidence for a NOAEL between 8 and 12 mg/kg bw/day and a LOAEL of 40 mg/kg bw/day. Since Montagnini et al. (2018), Montagnini et al. (2021) and Pernoncini et al. (2018) are well- performed Level 3 and Level 5 rat studies that show consistent results using standardised test guidelines (uterotrophic and Hershberger assays, and two-generation reproductive toxicity studies, respectively), the SCCS considers a PoD based on NOAEL of 8 mg/kg bw/day to be appropriate for safety assessment of triclosan. A 20-day repeated dose toxicity study an","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"12","page":31,"route":"","species":"rat","study_id":"sccs_o_265_noael_032"} |
| Regulatory source |
repeated dose toxicity |
=25 |
mg/kg bw/d |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 25; DOSE=Repeated dose toxicity Table 5:; LOAEL_VALUE=250 mg/kg bw/d; EFFECT=). Ref.: 43 3.3.5. Repeated dose toxicity Table 5: Summary of repeated dose toxicity Study type Species Endpoint Exposure Result Reference Subchronic (30 d) oral gavage Rat Subchronic toxicity 0, 500, 1000 mg/kg bw/d NOAEL > 1000 mg/kg bw/d Monsanto, 1960, Ref.: 19 Subchronic (8 w) dietary feeding Rat Subchronic toxicity 25, 75, 250 mg/kg bw/d NOAEL = 75 mg/kg bw/d LOAEL = 250 mg/kg bw/d Monsanto, 1985, Ref.: 24 Chronic (2 years) dietary feeding Rat Carcinogenicity and chronic toxicity 0, 25, 75, 250 mg/kg bw/d NOEL = 25 mg/kg bw/d LOEL = 75 mg/kg bw/d Not carcinogenic Monsanto, 1981 Ref.: 22; CITATION=Ref.: 43 3; CITATION_NUMBERS=[43,3]; REFERENCE=Ref.: 43 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 43 3","dose":"Repeated dose toxicity Table 5:","duration":"Subchronic","effect":"). Ref.: 43 3.3.5. Repeated dose toxicity Table 5: Summary of repeated dose toxicity Study type Species Endpoint Exposure Result Reference Subchronic (30 d) oral gavage Rat Subchronic toxicity 0, 500, 1000 mg/kg bw/d NOAEL > 1000 mg/kg bw/d Monsanto, 1960, Ref.: 19 Subchronic (8 w) dietary feeding Rat Subchronic toxicity 25, 75, 250 mg/kg bw/d NOAEL = 75 mg/kg bw/d LOAEL = 250 mg/kg bw/d Monsanto, 1985, Ref.: 24 Chronic (2 years) dietary feeding Rat Carcinogenicity and chronic toxicity 0, 25, 75, 250 mg/kg bw/d NOEL = 25 mg/kg bw/d LOEL = 75 mg/kg bw/d Not carcinogenic Monsanto, 1981 Ref.: 22","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"250 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":19,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_003"} |
| Regulatory source |
repeated dose toxicity |
25 |
mg/kg bw/d |
rat |
dermal |
2-year |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=25; DOSE=oses of 25, 75, and 250 mg/kg bw/d.; EFFECT=oses of 25, 75, and 250 mg/kg bw/d. There was no evidence for a dose-related increase in tumour incidence at any site and it was therefore concluded that Triclocarban was not carcinogenic under the conditions of the study. Establishment of a NOEL for human health risk assessment For assessing the risk associated with human exposure to Triclocarban in context of its use in antibacterial soaps and deodorant body wash, it was suggested to take the no observed effects level of 25 mg/kg bw/d. This value was the lowest NOEL from all repeated dose toxicity studies and derived from the results of a well conducted 2-year feeding study in rats. SUMMARY OF THE RISK ASSESSMENT Triclocarban-containing bar and liquid soaps and shower gels were utilised in “rinse-off” scenarios and dermal exposure occurring to the face, hands and the whole body during the cleansing process was the major route of exposure. The toxicological profile of Triclocarban indicates that the material has a low order of toxicity, based on a variety of acute, subchron; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"oses of 25, 75, and 250 mg/kg bw/d.","duration":"2-year","effect":"oses of 25, 75, and 250 mg/kg bw/d. There was no evidence for a dose-related increase in tumour incidence at any site and it was therefore concluded that Triclocarban was not carcinogenic under the conditions of the study. Establishment of a NOEL for human health risk assessment For assessing the risk associated with human exposure to Triclocarban in context of its use in antibacterial soaps and deodorant body wash, it was suggested to take the no observed effects level of 25 mg/kg bw/d. This value was the lowest NOEL from all repeated dose toxicity studies and derived from the results of a well conducted 2-year feeding study in rats. SUMMARY OF THE RISK ASSESSMENT Triclocarban-containing bar and liquid soaps and shower gels were utilised in “rinse-off” scenarios and dermal exposure occurring to the face, hands and the whole body during the cleansing process was the major route of exposure. The toxicological profile of Triclocarban indicates that the material has a low order of toxicity, based on a variety of acute, subchron","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":36,"route":"dermal","species":"rat","study_id":"sccp_o_016_noael_024"} |
| Regulatory source |
repeated dose toxicity |
30 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=30; DOSE=e / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs.; EFFECT=e / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs. In the SCCP Opinion SCCP/1192/08 (SCCP, 2009) the following rationale was given on the choice of NOAEL: “The derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOA; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"e / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs.","duration":"subchronic","effect":"e / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs. In the SCCP Opinion SCCP/1192/08 (SCCP, 2009) the following rationale was given on the choice of NOAEL: “The derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOA","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":16,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_008"} |
| Regulatory source |
repeated dose toxicity |
48 |
mg/kg bw/d |
rat |
oral |
95-week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=48; DOSE=EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.; EFFECT=ronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long-term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.","duration":"95-week","effect":"ronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long-term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"48","page":16,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_010"} |
| Regulatory source |
repeated dose toxicity |
48 |
mg/kg bw/d |
rat |
oral |
95-week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=48; DOSE=AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.; EFFECT=AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long-term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment.","duration":"95-week","effect":"AEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long-term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity studies in mice and rats, in hamsters only at higher doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in r","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"48","page":16,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_011"} |
| Regulatory source |
repeated dose toxicity |
65 |
mg/kg bw/d |
rat |
dermal |
1-year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=65; DOSE=The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day.; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day. Reproductive / developmental toxicity The SCCP (2009) derived a NOAEL of 65 mg/kg bw/d based on decreases in foetal body weights and the mean number of live pups reported in previous reproductive toxicity studies in the rat. Mutagenicity / genotoxicity Triclosan can be considered to have no relevant genotoxic potential in vivo. Carcinogenicity Triclosan is not classified as carcinogen according to CLP regulation. It should be noted that triclosan is a peroxisome proliferator in mice liver. Human data In addition to the indications of good tolerability and safety from historical a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day.","duration":"1-year","effect":"doses and in the 1-year toxicity study in baboons. This was further confirmed by changes in haematology parameters in the long-term studies in mice and hamsters. Interestingly, also in the 13-week subchronic dermal toxicity study in rats changes in erythrocytes parameters were observed. The SCCP will use the NOAEL of 12 mg/kg bw/d of the long-term toxicity study in rats for risk assessment.” The LOAEL from the 104-week rat study was 40 mg/kg bw/day. Reproductive / developmental toxicity The SCCP (2009) derived a NOAEL of 65 mg/kg bw/d based on decreases in foetal body weights and the mean number of live pups reported in previous reproductive toxicity studies in the rat. Mutagenicity / genotoxicity Triclosan can be considered to have no relevant genotoxic potential in vivo. Carcinogenicity Triclosan is not classified as carcinogen according to CLP regulation. It should be noted that triclosan is a peroxisome proliferator in mice liver. Human data In addition to the indications of good tolerability and safety from historical a","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/d","noael_value":"65","page":16,"route":"dermal","species":"rat","study_id":"sccs_o_265_noael_013"} |
| Regulatory source |
repeated dose toxicity |
=75 |
mg/kg bw/d |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 75; DOSE=y excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985).; LOAEL_VALUE=250 mg/kg bw/d; EFFECT=y excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985). Ref.: 43 3.3.5. Repeated dose toxicity Table 5: Summary of repeated dose toxicity Study type Species Endpoint Exposure Result Reference Subchronic (30 d) oral gavage Rat Subchronic toxicity 0, 500, 1000 mg/kg bw/d NOAEL > 1000 mg/kg bw/d Monsanto, 1960, Ref.: 19 Subchronic (8 w) dietary feeding Rat Subchronic toxicity 25, 75, 250 mg/kg bw/d NOAEL = 75 mg/kg bw/d LOAEL = 250 mg/kg bw/d Monsanto, 1985, Ref.: 24 Chronic (2 years) dietary feeding Rat Carcinogenicity and chronic toxicity 0, 25, 75, 250 mg/kg bw/d NOEL = 25 mg/kg bw/d LOEL = 75 mg/kg bw/d Not carcinogenic Monsanto, 1981 Ref.: 22; CITATION=Ref.: 43 3; CITATION_NUMBERS=[43,3]; REFERENCE=Ref.: 43 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 43 3","dose":"y excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985).","duration":"Subchronic","effect":"y excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985). Ref.: 43 3.3.5. Repeated dose toxicity Table 5: Summary of repeated dose toxicity Study type Species Endpoint Exposure Result Reference Subchronic (30 d) oral gavage Rat Subchronic toxicity 0, 500, 1000 mg/kg bw/d NOAEL > 1000 mg/kg bw/d Monsanto, 1960, Ref.: 19 Subchronic (8 w) dietary feeding Rat Subchronic toxicity 25, 75, 250 mg/kg bw/d NOAEL = 75 mg/kg bw/d LOAEL = 250 mg/kg bw/d Monsanto, 1985, Ref.: 24 Chronic (2 years) dietary feeding Rat Carcinogenicity and chronic toxicity 0, 25, 75, 250 mg/kg bw/d NOEL = 25 mg/kg bw/d LOEL = 75 mg/kg bw/d Not carcinogenic Monsanto, 1981 Ref.: 22","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"250 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"= 75","page":19,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_002"} |
| Regulatory source |
repeated dose toxicity |
75 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=75; DOSE=reater than 5,000 mg/kg body weight in dogs.; EFFECT=reater than 5,000 mg/kg body weight in dogs. In the SCCP Opinion SCCP/1192/08 (SCCP, 2009) the following rationale was given on the choice of NOAEL: “The derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long-term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"reater than 5,000 mg/kg body weight in dogs.","duration":"subchronic","effect":"reater than 5,000 mg/kg body weight in dogs. In the SCCP Opinion SCCP/1192/08 (SCCP, 2009) the following rationale was given on the choice of NOAEL: “The derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alternatively, as a more conservative value, the NOAEL of the 104-week rat study (≈ 48 mg/kg bw/d for both sexes) was used. SCCP considers the NOAEL of this long-term toxicity study in rats as 12 - 17 mg/kg bw/d (≈ 14.5 mg/kg bw/d) due to haematotoxicity and decreased absolute and relative spleen weights. Haematotoxicity was also detected in the 13-week subchronic oral toxicity s","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":16,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_009"} |
| Regulatory source |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
Sub-chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=250; DOSE=Mean bodyweight and food consumption were lower in the highest dose group, however the statistical significance of this difference could not be evaluated due to the absence of a control group.; LOAEL_VALUE=250 mg/kg bw/d; EFFECT=d samples were taken from 5 animals per group every two weeks for evaluation of blood levels of Triclocarban. No necropsy was performed at the end of the study. There were no signs of toxicity or treatment related mortalities throughout the study. Mean bodyweight and food consumption were lower in the highest dose group, however the statistical significance of this difference could not be evaluated due to the absence of a control group. No compound-related pathological or histopathological findings were noted. The NOAEL and LOAEL were determined to be 75 and 250 mg/kg bw/d, respectively. The absence of a control group, histology of tissues and blood chemistry is a critical weakness in this study. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted 3.3.5.3. Chronic (> 12 months) toxicity Triclocarban was tested in groups of 80 Sprague Dawley rats per sex in a two year chronic feeding study at dose levels of 0, 25, 75 and 250mg/kg bw/d (Monsanto, 1981). Clinical signs, body weight and f; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 24 3","dose":"Mean bodyweight and food consumption were lower in the highest dose group, however the statistical significance of this difference could not be evaluated due to the absence of a control group.","duration":"Sub-chronic","effect":"d samples were taken from 5 animals per group every two weeks for evaluation of blood levels of Triclocarban. No necropsy was performed at the end of the study. There were no signs of toxicity or treatment related mortalities throughout the study. Mean bodyweight and food consumption were lower in the highest dose group, however the statistical significance of this difference could not be evaluated due to the absence of a control group. No compound-related pathological or histopathological findings were noted. The NOAEL and LOAEL were determined to be 75 and 250 mg/kg bw/d, respectively. The absence of a control group, histology of tissues and blood chemistry is a critical weakness in this study. Ref.: 24 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted 3.3.5.3. Chronic (> 12 months) toxicity Triclocarban was tested in groups of 80 Sprague Dawley rats per sex in a two year chronic feeding study at dose levels of 0, 25, 75 and 250mg/kg bw/d (Monsanto, 1981). Clinical signs, body weight and f","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"250 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"250","page":20,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_006"} |
| Regulatory source |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=250; DOSE=The potential for carcinogenicity was further evaluated in a two year rat chronic feeding study in which rats were fed with a diet containing Triclocarban at doses of 25, 75, and 250 mg/kg bw/d.; EFFECT=e mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. The potential for carcinogenicity was further evaluated in a two year rat chronic feeding study in which rats were fed with a diet containing Triclocarban at doses of 25, 75, and 250 mg/kg bw/d. There was no evidence for a dose-related increase in tumour incidence at any site and it was therefore concluded that Triclocarban was not carcinogenic under the conditions of the study. Establishment of a NOEL for human health risk assessment For assessing the risk associated with human exposure to Triclocarban in context of its use in antibacterial soaps and deodorant body wash, it was suggested to take the no observed effects level of 25 mg/kg bw/d. This value was the lowest NOEL from all repeated dose toxicity studies and derived from the results of a well conducted 2-year feeding study in rats. SUMMARY OF THE RISK ASSESSMENT Triclocarban-containing bar and liquid soaps and shower gels were utilised in “rinse-off”; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The potential for carcinogenicity was further evaluated in a two year rat chronic feeding study in which rats were fed with a diet containing Triclocarban at doses of 25, 75, and 250 mg/kg bw/d.","duration":"chronic","effect":"e mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. The potential for carcinogenicity was further evaluated in a two year rat chronic feeding study in which rats were fed with a diet containing Triclocarban at doses of 25, 75, and 250 mg/kg bw/d. There was no evidence for a dose-related increase in tumour incidence at any site and it was therefore concluded that Triclocarban was not carcinogenic under the conditions of the study. Establishment of a NOEL for human health risk assessment For assessing the risk associated with human exposure to Triclocarban in context of its use in antibacterial soaps and deodorant body wash, it was suggested to take the no observed effects level of 25 mg/kg bw/d. This value was the lowest NOEL from all repeated dose toxicity studies and derived from the results of a well conducted 2-year feeding study in rats. SUMMARY OF THE RISK ASSESSMENT Triclocarban-containing bar and liquid soaps and shower gels were utilised in “rinse-off”","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":36,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_023"} |
| Regulatory source |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
2-year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=250; DOSE=Acute / repeated dose toxicity Triclocarban was found to be low acute oral, dermal and intraperitoneal toxicity.; EFFECT=valuation of triclocarban Irritation / sensitisation Data from experimental animal and/or human studies indicate that triclocarban is a weak skin irritant but not an eye irritant. Experimental and clinical data show no evidence of skin sensitisation. Triclocarban has been found to be non-photoallergenic in an experimental animal study. Acute / repeated dose toxicity Triclocarban was found to be low acute oral, dermal and intraperitoneal toxicity. In SCCP (2005) the following rationale was given on the choice of NOEL: In the 2-year chronic feeding study, the rats were fed with a diet containing triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) wer; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Acute / repeated dose toxicity Triclocarban was found to be low acute oral, dermal and intraperitoneal toxicity.","duration":"2-year","effect":"valuation of triclocarban Irritation / sensitisation Data from experimental animal and/or human studies indicate that triclocarban is a weak skin irritant but not an eye irritant. Experimental and clinical data show no evidence of skin sensitisation. Triclocarban has been found to be non-photoallergenic in an experimental animal study. Acute / repeated dose toxicity Triclocarban was found to be low acute oral, dermal and intraperitoneal toxicity. In SCCP (2005) the following rationale was given on the choice of NOEL: In the 2-year chronic feeding study, the rats were fed with a diet containing triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) wer","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":15,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_001"} |
| Regulatory source |
repeated dose toxicity |
>1000 |
mg/kg bw/d |
rat |
oral |
Subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=> 1000; DOSE=On the basis of urinary excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985).; LOAEL_VALUE=250 mg/kg bw/d; EFFECT=ratio of urinary excretion of radiolabeled Triclocarban following topical and intravenous administration. On the basis of urinary excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985). Ref.: 43 3.3.5. Repeated dose toxicity Table 5: Summary of repeated dose toxicity Study type Species Endpoint Exposure Result Reference Subchronic (30 d) oral gavage Rat Subchronic toxicity 0, 500, 1000 mg/kg bw/d NOAEL > 1000 mg/kg bw/d Monsanto, 1960, Ref.: 19 Subchronic (8 w) dietary feeding Rat Subchronic toxicity 25, 75, 250 mg/kg bw/d NOAEL = 75 mg/kg bw/d LOAEL = 250 mg/kg bw/d Monsanto, 1985, Ref.: 24 Chronic (2 years) dietary feeding Rat Carcinogenicity and chronic toxicity 0, 25, 75, 250 mg/kg bw/d NOEL = 25 mg/kg bw/d LOEL = 75 mg/kg bw/d Not carcinogenic Monsanto, 1981 Ref.: 22; CITATION=Ref.: 43 3; CITATION_NUMBERS=[43,3]; REFERENCE=Ref.: 43 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 43 3","dose":"On the basis of urinary excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985).","duration":"Subchronic","effect":"ratio of urinary excretion of radiolabeled Triclocarban following topical and intravenous administration. On the basis of urinary excretion of 14C-labeled Triclocarban species, it was calculated that about 7.0% ± 2.8% of the totally administered dose penetrated through the skin (Wester et al., 1985). Ref.: 43 3.3.5. Repeated dose toxicity Table 5: Summary of repeated dose toxicity Study type Species Endpoint Exposure Result Reference Subchronic (30 d) oral gavage Rat Subchronic toxicity 0, 500, 1000 mg/kg bw/d NOAEL > 1000 mg/kg bw/d Monsanto, 1960, Ref.: 19 Subchronic (8 w) dietary feeding Rat Subchronic toxicity 25, 75, 250 mg/kg bw/d NOAEL = 75 mg/kg bw/d LOAEL = 250 mg/kg bw/d Monsanto, 1985, Ref.: 24 Chronic (2 years) dietary feeding Rat Carcinogenicity and chronic toxicity 0, 25, 75, 250 mg/kg bw/d NOEL = 25 mg/kg bw/d LOEL = 75 mg/kg bw/d Not carcinogenic Monsanto, 1981 Ref.: 22","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"250 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"> 1000","page":19,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_001"} |
| Regulatory source |
repeated dose toxicity |
5000 |
mg/kg |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=5,000; DOSE=Acute / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs.; EFFECT=nce has shown that triclosan does have a low sensitisation potential in humans. Possible photocontact allergy has been rarely reported. Acute / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs. In the SCCP Opinion SCCP/1192/08 (SCCP, 2009) the following rationale was given on the choice of NOAEL: “The derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alter; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Acute / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs.","duration":"subchronic","effect":"nce has shown that triclosan does have a low sensitisation potential in humans. Possible photocontact allergy has been rarely reported. Acute / repeated dose toxicity Triclosan is not acutely toxic via the oral route of administration, with high oral intubation LD50 values in the range of 3,750 to 5,000 mg/kg body weight in mice and rats, and an oral capsule LD50 value of greater than 5,000 mg/kg body weight in dogs. In the SCCP Opinion SCCP/1192/08 (SCCP, 2009) the following rationale was given on the choice of NOAEL: “The derived NOAELs from subchronic and chronic studies in different species were compiled. EPA in its recent evaluation selected the NOAEL of the baboon study (30 mg/kg bw/d) for risk assessment based on clinical signs of toxicity which are presumably due to oral treatment. This might not be relevant for cosmetic uses. The applicant in its safety evaluation used the NOAEL of the 95-week study in hamsters as this species was judged to be the most relevant to humans based on pharmacokinetics (75 mg/kg bw/d). Alter","endpoint":"repeated dose toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"5,000","page":16,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_007"} |
| Regulatory source |
repeated dose toxicity |
10000 |
ppm |
rat |
oral |
Chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=10000; DOSE=SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 20 Study type Species Endpoint Exposure Result Reference Chronic (2 year) dietary feeding Rat Chronic toxicity 1000, 3000, 10000 ppm Insufficient study information to establish a NOEL Wright et al., 1975 Ref.:; EFFECT=SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 20 Study type Species Endpoint Exposure Result Reference Chronic (2 year) dietary feeding Rat Chronic toxicity 1000, 3000, 10000 ppm Insufficient study information to establish a NOEL Wright et al., 1975 Ref.: 44 3.3.5.1. Repeated Dose (28 days) oral / dermal / inhalation toxicity Sprague-Dawley rats (10 animals/sex /group) were dosed with a 25% aqueous solution of Triclocarban at 0 (controls), 500 or 1000 mg/kg bw by intubation 5 days a week during 30 days (Monsanto, 1960). Food consumption and body weights were recorded weekly and observations were made for signs of toxicity. After 30 days, representative animals from each group were sacrificed for necropsy. The viscera of the 1000 mg/kg b; CITATION=Ref.: 44 3; CITATION_NUMBERS=[44,3]; REFERENCE=Ref.: 44 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 44 3","dose":"SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 20 Study type Species Endpoint Exposure Result Reference Chronic (2 year) dietary feeding Rat Chronic toxicity 1000, 3000, 10000 ppm Insufficient study information to establish a NOEL Wright et al., 1975 Ref.:","duration":"Chronic","effect":"SCCP/0851/04 Opinion on triclocarban (P29) for other uses than as a preservative 20 Study type Species Endpoint Exposure Result Reference Chronic (2 year) dietary feeding Rat Chronic toxicity 1000, 3000, 10000 ppm Insufficient study information to establish a NOEL Wright et al., 1975 Ref.: 44 3.3.5.1. Repeated Dose (28 days) oral / dermal / inhalation toxicity Sprague-Dawley rats (10 animals/sex /group) were dosed with a 25% aqueous solution of Triclocarban at 0 (controls), 500 or 1000 mg/kg bw by intubation 5 days a week during 30 days (Monsanto, 1960). Food consumption and body weights were recorded weekly and observations were made for signs of toxicity. After 30 days, representative animals from each group were sacrificed for necropsy. The viscera of the 1000 mg/kg b","endpoint":"repeated dose toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"10000","page":20,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_004"} |
| Regulatory source |
reproductive toxicity |
0 |
- |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=unclear:icant differences (compared to control group) are largely limited to the highest tested dose. No apical effects on reproductive performance were reported in these studies. The SCCS considers that the hormonal/behavioural parameters evaluated in both female and male offspring following maternal exposure of Wistar rat to triclocarban are sensitive paramaters that may be indicative of an endocrine activity, but that as such as they are not directly linked to an adverse effect and therefore cannot be used to derive a NOAEL/LOAEL.; DOSE=icant differences (compared to control group) are largely limited to the highest tested dose.; EFFECT=SCCS-rejected applicant NOAEL: icant differences (compared to control group) are largely limited to the highest tested dose. No apical effects on reproductive performance were reported in these studies. The SCCS considers that the hormonal/behavioural parameters evaluated in both female and male offspring following maternal exposure of Wistar rat to triclocarban are sensitive paramaters that may be indicative of an endocrine activity, but that as such as they are not directly linked to an adverse effect and therefore cannot be used to derive a NOAEL/LOAEL.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"icant differences (compared to control group) are largely limited to the highest tested dose.","duration":"","effect":"SCCS-rejected applicant NOAEL: icant differences (compared to control group) are largely limited to the highest tested dose. No apical effects on reproductive performance were reported in these studies. The SCCS considers that the hormonal/behavioural parameters evaluated in both female and male offspring following maternal exposure of Wistar rat to triclocarban are sensitive paramaters that may be indicative of an endocrine activity, but that as such as they are not directly linked to an adverse effect and therefore cannot be used to derive a NOAEL/LOAEL.","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"","noael_value":"unclear:icant differences (compared to control group) are largely limited to the highest tested dose. No apical effects on reproductive performance were reported in these studies. The SCCS considers that the hormonal/behavioural parameters evaluated in both female and male offspring following maternal exposure of Wistar rat to triclocarban are sensitive paramaters that may be indicative of an endocrine activity, but that as such as they are not directly linked to an adverse effect and therefore cannot be used to derive a NOAEL/LOAEL.","page":23,"route":"","species":"rat","study_id":"sccs_o_265_noael_017"} |
| Regulatory source |
reproductive toxicity |
<0.2 |
% |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=< 0.2; DOSE=e Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.:; EFFECT=e Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26; CITATION=Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0; CITATION_NUMBERS=[23,2,1]; REFERENCE=Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0","dose":"e Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.:","duration":"developmental","effect":"e Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"%","noael_value":"< 0.2","page":23,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_011"} |
| Regulatory source |
reproductive toxicity |
<0.2 |
% |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=< 0.2; EFFECT=Table 8: summary of reproductive and developmental toxicity: NOEL < 0.2%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: NOEL < 0.2%","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"%","noael_value":"< 0.2","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_031"} |
| Regulatory source |
reproductive toxicity |
=0.25 |
% |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 0.25; EFFECT=Table 8: summary of reproductive and developmental toxicity: toxicity and | Oral: 0.1%, | LOEL = 0.25% | Ref.: 26; CITATION=Ref.: 26; CITATION_NUMBERS=[26]; REFERENCE=Ref.: 26; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 26","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: toxicity and | Oral: 0.1%, | LOEL = 0.25% | Ref.: 26","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"%","noael_value":"= 0.25","page":23,"route":"oral","species":"","study_id":"sccp_o_016_noael_037"} |
| Regulatory source |
reproductive toxicity |
0.4 |
mg/kg |
- |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=0.4; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; LOAEL_VALUE=0.4 mg/kg; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________77 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) doses + 0.4 mg/kg testosterone propionate Positive control testosterone propionate n = 6/group histomorphometry ↔ Hershberger assay: bw and reproductive organ weights; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________77 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) doses + 0.4 mg/kg testosterone propionate Positive control testosterone propionate n = 6/group histomorphometry ↔ Hershberger assay: bw and reproductive organ weights","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"0.4 mg/kg","noael_unit":"mg/kg","noael_value":"0.4","page":77,"route":"","species":"","study_id":"sccs_o_265_noael_067"} |
| Regulatory source |
reproductive toxicity |
=1 |
mg/kg bw/day |
rat |
- |
6 weeks |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 1; DOSE=In triclosan treated mice, the treatment with L-T4 corrected the increases in prolactin, TSH and TRH.; LOAEL_VALUE=10 mg/kg bw/day; EFFECT=and TRH. In triclosan treated mice, the treatment with L-T4 corrected the increases in prolactin, TSH and TRH. Furthermore, triclosan mice treated with L-T4 or quinpirole resumed regular estrous cycling, follicular development and ovulation. The authors concluded that these findings indicate that exposing adult female mice to triclosan (≥10 mg/kg) reduces thyroid hormones causing hyperprolactinemia that then suppresses hypothalamic kisspeptin expression, leading to deficits in reproductive endocrine and function. NOAEL = 1 mg/kg bw/day. LOAEL = 10 mg/kg bw/day. Ref.: Cao 2018 Male reproduction Lan et al. (2013) investigated triclosan-induced sperm toxicity and histopathological changes of reproductive organs in Sprague-Dawley rats (6 weeks old). Triclosan in corn oil was given intragastrically at doses of 0, 10, 50 and 200 mg/kg for 8 weeks (n=8/group). After the final treatment, all testes and epididymides were excised and weighed. The left testis and; CITATION=Ref.: Cao 2018 Male reproduction Lan et al; CITATION_NUMBERS=[2018]; REFERENCE=Ref.: Cao 2018 Male reproduction Lan et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Cao 2018 Male reproduction Lan et al","dose":"In triclosan treated mice, the treatment with L-T4 corrected the increases in prolactin, TSH and TRH.","duration":"6 weeks","effect":"and TRH. In triclosan treated mice, the treatment with L-T4 corrected the increases in prolactin, TSH and TRH. Furthermore, triclosan mice treated with L-T4 or quinpirole resumed regular estrous cycling, follicular development and ovulation. The authors concluded that these findings indicate that exposing adult female mice to triclosan (≥10 mg/kg) reduces thyroid hormones causing hyperprolactinemia that then suppresses hypothalamic kisspeptin expression, leading to deficits in reproductive endocrine and function. NOAEL = 1 mg/kg bw/day. LOAEL = 10 mg/kg bw/day. Ref.: Cao 2018 Male reproduction Lan et al. (2013) investigated triclosan-induced sperm toxicity and histopathological changes of reproductive organs in Sprague-Dawley rats (6 weeks old). Triclosan in corn oil was given intragastrically at doses of 0, 10, 50 and 200 mg/kg for 8 weeks (n=8/group). After the final treatment, all testes and epididymides were excised and weighed. The left testis and","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"10 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"= 1","page":27,"route":"","species":"rat","study_id":"sccs_o_265_noael_025"} |
| Regulatory source |
reproductive toxicity |
1.5 |
mg/kg bw/day |
- |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=1.5; DOSE=The NOAEL derived from this study was 1.5 mg/kg bw/day.; EFFECT=tency to the first intromission, no. of intromissions until the first ejaculation, latency to the first ejaculation, latency to the first post-ejaculatory intromission, no. of post-ejaculatory intromissions, no. of ejaculation, preference score). On PND 120, no significant differences were noted between groups for final body weight, reproductive organs weight, testosterone levels, testis histomorphometric parameters, sperm motility, viability, morphology sperm count through testis, epididymis and vas deferens. The NOAEL derived from this study was 1.5 mg/kg bw/day. Ref.: Costa 2020b SCCS comment Costa et al. (2020a and 2020b) have evaluated the effects of maternal exposure to triclocarban on the reproductive parameters of female and male offspring respectively. Among the several measured parameters in the female offspring, the statistically significant effects were a decrease in the progesterone levels at the highest tested dose, a decrease in estradiol levels at the lowest and the highest doses (but not the middle dose), and an; CITATION=Ref.: Costa 2020b SCCS comment Costa et al; CITATION_NUMBERS=[2020]; REFERENCE=Ref.: Costa 2020b SCCS comment Costa et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Costa 2020b SCCS comment Costa et al","dose":"The NOAEL derived from this study was 1.5 mg/kg bw/day.","duration":"","effect":"tency to the first intromission, no. of intromissions until the first ejaculation, latency to the first ejaculation, latency to the first post-ejaculatory intromission, no. of post-ejaculatory intromissions, no. of ejaculation, preference score). On PND 120, no significant differences were noted between groups for final body weight, reproductive organs weight, testosterone levels, testis histomorphometric parameters, sperm motility, viability, morphology sperm count through testis, epididymis and vas deferens. The NOAEL derived from this study was 1.5 mg/kg bw/day. Ref.: Costa 2020b SCCS comment Costa et al. (2020a and 2020b) have evaluated the effects of maternal exposure to triclocarban on the reproductive parameters of female and male offspring respectively. Among the several measured parameters in the female offspring, the statistically significant effects were a decrease in the progesterone levels at the highest tested dose, a decrease in estradiol levels at the lowest and the highest doses (but not the middle dose), and an","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1.5","page":23,"route":"","species":"","study_id":"sccs_o_265_noael_016"} |
| Regulatory source |
reproductive toxicity |
=4.69 |
mg/kg bw/day |
mouse |
- |
8 months |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 4.69; DOSE=ncentrations of T4 were significantly decreased in females following 8 months of treatment with 9.375 or 37.5 mg/kg of triclosan compared to controls by approximately 17 and 35%, respectively.; EFFECT=SCCS-rejected applicant NOAEL: ncentrations of T4 were significantly decreased in females following 8 months of treatment with 9.375 or 37.5 mg/kg of triclosan compared to controls by approximately 17 and 35%, respectively. No marked effects on thyroid tissue weight and histology were observed. Hepatic enzyme gene expression: There was a dose-dependent 2.2-fold increase in gene expression of Cyp2b2 at 37.5 mg/kg triclosan, whereas Cyp3a23/3a1, Sult1c1/1c3, Sult1b1, and Ugt1a1, were not significantly different from control liver gene expression. NOAEL = 4.69 mg/kg bw/day. Since the only effect of 8 months of daily treatment with triclosan was seen for T4 with no changes in T3 and TSH, as well as thyroid tissue weight and histology, estrous cyclicity and reproductive hormones (E1, E2, progesterone, LH), Louis et al. (2017) is not used by the SCCS to derive a PoD. Ref.: Louis 2017 After 3–4 regular estrous cycles, female ICR mice were given triclosan orally at doses of 0 (corn oil), 1, 10 and 100 mg/kg bw/day for 50 days (Cao et al. 2018). In a second experiment; CITATION=Ref.: Louis 2017 After 3–4 regular estrous cycles, female ICR mice were given triclosan orally at doses of 0 (corn oil), 1, 10 and 100 mg/kg bw/day for 50 days (Cao et al; CITATION_NUMBERS=[2017,3,4,1,10,100,50]; REFERENCE=Ref.: Louis 2017 After 3–4 regular estrous cycles, female ICR mice were given triclosan orally at doses of 0 (corn oil), 1, 10 and 100 mg/kg bw/day for 50 days (Cao et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Louis 2017 After 3–4 regular estrous cycles, female ICR mice were given triclosan orally at doses of 0 (corn oil), 1, 10 and 100 mg/kg bw/day for 50 days (Cao et al","dose":"ncentrations of T4 were significantly decreased in females following 8 months of treatment with 9.375 or 37.5 mg/kg of triclosan compared to controls by approximately 17 and 35%, respectively.","duration":"8 months","effect":"SCCS-rejected applicant NOAEL: ncentrations of T4 were significantly decreased in females following 8 months of treatment with 9.375 or 37.5 mg/kg of triclosan compared to controls by approximately 17 and 35%, respectively. No marked effects on thyroid tissue weight and histology were observed. Hepatic enzyme gene expression: There was a dose-dependent 2.2-fold increase in gene expression of Cyp2b2 at 37.5 mg/kg triclosan, whereas Cyp3a23/3a1, Sult1c1/1c3, Sult1b1, and Ugt1a1, were not significantly different from control liver gene expression. NOAEL = 4.69 mg/kg bw/day. Since the only effect of 8 months of daily treatment with triclosan was seen for T4 with no changes in T3 and TSH, as well as thyroid tissue weight and histology, estrous cyclicity and reproductive hormones (E1, E2, progesterone, LH), Louis et al. (2017) is not used by the SCCS to derive a PoD. Ref.: Louis 2017 After 3–4 regular estrous cycles, female ICR mice were given triclosan orally at doses of 0 (corn oil), 1, 10 and 100 mg/kg bw/day for 50 days (Cao et al. 2018). In a second experiment","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 4.69","page":27,"route":"","species":"mouse","study_id":"sccs_o_265_noael_024"} |
| Regulatory source |
reproductive toxicity |
6.75 |
mg/kg bw/d |
human |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=6.75; DOSE=The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d.; EFFECT=reproductive/ developmental effects in in vivo animal studies. The risk to human health was characterised by dividing the lowest NOEL derived from animal toxicity studies by the estimated maximum systemic exposure. The quotient is generally referred to as the Margin of Safety (i.e., MOS). The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d. Dividing the internal NOEL of Triclocarban of 6.75 mg/kg bw/d (25 mg/kg bw/d derived from a 2-year chronic feeding study and corrected for an oral bioavailability of 27%) by this exposure results in a MOS of 210 for a for 60kg adult. 4. CONCLUSION In response to the questions asked, the SCCP is of the opinion that that the use of Triclocarban for non-preservative purposes in cosmetic rinse-off hand and body care products up to a maximum concentration of 1.5% does not pose a direct risk to the health of the consumer. However, the SCCP wo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d.","duration":"developmental","effect":"reproductive/ developmental effects in in vivo animal studies. The risk to human health was characterised by dividing the lowest NOEL derived from animal toxicity studies by the estimated maximum systemic exposure. The quotient is generally referred to as the Margin of Safety (i.e., MOS). The worst-case scenario for dermal exposure to Triclocarban from the combined use in bar and liquid soaps and shower gels at levels up to 1.5% led to an estimated systemic exposure dose of 0.032 mg/kg bw/d. Dividing the internal NOEL of Triclocarban of 6.75 mg/kg bw/d (25 mg/kg bw/d derived from a 2-year chronic feeding study and corrected for an oral bioavailability of 27%) by this exposure results in a MOS of 210 for a for 60kg adult. 4. CONCLUSION In response to the questions asked, the SCCP is of the opinion that that the use of Triclocarban for non-preservative purposes in cosmetic rinse-off hand and body care products up to a maximum concentration of 1.5% does not pose a direct risk to the health of the consumer. However, the SCCP wo","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"6.75","page":36,"route":"oral","species":"human","study_id":"sccp_o_016_noael_026"} |
| Regulatory source |
reproductive toxicity |
=8 |
mg/kg bw/day |
rat |
oral |
49-day |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 8; DOSE=emales from triclosan in the 8.0 mg/kg/day group and growing follicle number of triclosan 2.4 mg/kg/day females from F1 generation.; EFFECT=emales from triclosan in the 8.0 mg/kg/day group and growing follicle number of triclosan 2.4 mg/kg/day females from F1 generation. Despite some specific changes detected in the two-generation study, no impairment was observed in the uterotrophic assay (see section 3.4.3.4) and other important reproductive endpoints. The authors concluded that, in a weight of evidence evaluation, the results suggest that exposure to triclosan at low doses did not act as an endocrine disruptor in the female rat reproductive system. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2018 Pernoncini et al. (2018) evaluated the sexual behaviour, sperm motility, sperm viability, and testicular histomorphometry of triclosan in 49-day old male Wistar rats (OECD TG 416). Triclosan dosages were based on the acceptable daily intake, in addition to 3 and 10-fold higher doses. Male rats were administered by gavage corn oil (control) or 0.8, 2.4 or 8 mg/kg of triclosan (n=10/group). Test item was given daily from PND 49 till PND 140. No statistical difference was dete; CITATION=Ref.: Montagnini 2018 Pernoncini et al; CITATION_NUMBERS=[2018]; REFERENCE=Ref.: Montagnini 2018 Pernoncini et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Montagnini 2018 Pernoncini et al","dose":"emales from triclosan in the 8.0 mg/kg/day group and growing follicle number of triclosan 2.4 mg/kg/day females from F1 generation.","duration":"49-day","effect":"emales from triclosan in the 8.0 mg/kg/day group and growing follicle number of triclosan 2.4 mg/kg/day females from F1 generation. Despite some specific changes detected in the two-generation study, no impairment was observed in the uterotrophic assay (see section 3.4.3.4) and other important reproductive endpoints. The authors concluded that, in a weight of evidence evaluation, the results suggest that exposure to triclosan at low doses did not act as an endocrine disruptor in the female rat reproductive system. NOAEL = 8 mg/kg bw/day. Ref.: Montagnini 2018 Pernoncini et al. (2018) evaluated the sexual behaviour, sperm motility, sperm viability, and testicular histomorphometry of triclosan in 49-day old male Wistar rats (OECD TG 416). Triclosan dosages were based on the acceptable daily intake, in addition to 3 and 10-fold higher doses. Male rats were administered by gavage corn oil (control) or 0.8, 2.4 or 8 mg/kg of triclosan (n=10/group). Test item was given daily from PND 49 till PND 140. No statistical difference was dete","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 8","page":29,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_028"} |
| Regulatory source |
reproductive toxicity |
=8 |
mg/kg bw/day |
rat |
oral |
10 weeks |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 8; DOSE=NOAEL = 8 mg/kg bw/day.; EFFECT=g properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 30 seminiferous tubules volume or the diameter of seminiferous tubules. The results demonstrated that triclosan did not act as an endocrine disrupter, with no (anti)androgenic effect in the Hershberger assay (see section 3.4.3.4) and without interfering with the parameters evaluated in the reproductive toxicity study. NOAEL = 8 mg/kg bw/day. Ref.: Pernoncini 2018 In a two-generation reproduction toxicity study in males based on OECD 416 and 426, female and male Wistar rats were treated daily by gavage with triclosan at doses of 0.8, 2.4, and 8.0 mg/kg/day or corn oil (control group) over 10 weeks (F0) and over 14 weeks (F1) before mating and then throughout mating, until weaning F2 generations, respectively (Montagnini et al. 2021). In F1 during premating, no mortality, morbidity, body and organ weight change, or general signs of t; CITATION=Ref.: Pernoncini 2018 In a two-generation reproduction toxicity study in males based on OECD 416 and 426, female and male Wistar rats were treated daily by gavage with triclosan at doses; CITATION_NUMBERS=[2018,416,426]; REFERENCE=Ref.: Pernoncini 2018 In a two-generation reproduction toxicity study in males based on OECD 416 and 426, female and male Wistar rats were treated daily by gavage with triclosan at doses; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Pernoncini 2018 In a two-generation reproduction toxicity study in males based on OECD 416 and 426, female and male Wistar rats were treated daily by gavage with triclosan at doses","dose":"NOAEL = 8 mg/kg bw/day.","duration":"10 weeks","effect":"g properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________ 30 seminiferous tubules volume or the diameter of seminiferous tubules. The results demonstrated that triclosan did not act as an endocrine disrupter, with no (anti)androgenic effect in the Hershberger assay (see section 3.4.3.4) and without interfering with the parameters evaluated in the reproductive toxicity study. NOAEL = 8 mg/kg bw/day. Ref.: Pernoncini 2018 In a two-generation reproduction toxicity study in males based on OECD 416 and 426, female and male Wistar rats were treated daily by gavage with triclosan at doses of 0.8, 2.4, and 8.0 mg/kg/day or corn oil (control group) over 10 weeks (F0) and over 14 weeks (F1) before mating and then throughout mating, until weaning F2 generations, respectively (Montagnini et al. 2021). In F1 during premating, no mortality, morbidity, body and organ weight change, or general signs of t","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 8","page":30,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_029"} |
| Regulatory source |
reproductive toxicity |
8 |
mg/kg bw/day |
rat |
- |
2-year |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8; DOSE=on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005).; EFFECT=on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005). Triclosan Several studies have demonstrated estrogenic activity and anti-androgenic activity of triclosan, through both direct and indirect MoA, confirming the androgen- and estrogen- mediated activity of triclosan. There is also evidence of endocrine activity of triclosan from in vivo animal studies, whereas there are either no or inconsistent findings in human studies. The SCCS has selected a PoD based on NOAEL of 8 mg/kg bw/day for triclosan from the reproductive toxicity assays in rats performed by Montagnini et al. (2018, 2021) and Pernoncini et al. (2018). Table 3. Summary of human studies on triclosan ↑: positive association; ↔: no association; ↓: inverse association Reference N Exposure period Outcome measurement period T4 T3 TSH Estriol Sperm Fecundity Birth outcome2 Foetal abnormality Puberty3 Conc/ count Other1 Ley 2017 154 P NB Aker 2018 439 P P ↓ ↑ Aker 2019 602 P P ↑ Braun 2018 153- 274 P P; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005).","duration":"2-year","effect":"on NOAEL of 25 mg/kg bw/day for triclocarban based on a 2-year chronic feeding study in rats (SCCP 2005). Triclosan Several studies have demonstrated estrogenic activity and anti-androgenic activity of triclosan, through both direct and indirect MoA, confirming the androgen- and estrogen- mediated activity of triclosan. There is also evidence of endocrine activity of triclosan from in vivo animal studies, whereas there are either no or inconsistent findings in human studies. The SCCS has selected a PoD based on NOAEL of 8 mg/kg bw/day for triclosan from the reproductive toxicity assays in rats performed by Montagnini et al. (2018, 2021) and Pernoncini et al. (2018). Table 3. Summary of human studies on triclosan ↑: positive association; ↔: no association; ↓: inverse association Reference N Exposure period Outcome measurement period T4 T3 TSH Estriol Sperm Fecundity Birth outcome2 Foetal abnormality Puberty3 Conc/ count Other1 Ley 2017 154 P NB Aker 2018 439 P P ↓ ↑ Aker 2019 602 P P ↑ Braun 2018 153- 274 P P","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"8","page":34,"route":"","species":"rat","study_id":"sccs_o_265_noael_037"} |
| Regulatory source |
reproductive toxicity |
8 |
mg/kg |
rat |
oral |
10 weeks |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8.0; DOSE=0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weights in F0 or F1 females: uterus, ovary, liver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ gr...; EFFECT=trogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weights in F0 or F1 females: uterus, ovary, liver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ growing follicle number in F1 at 2.4 NOAEL = 8 Pernoncini et al. 2018 Male wistar rats Gavage of 49 day old rats from PND 49- PND140 Doses: 0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher: 0, 0.8, 2.4 and 8.0 mg/kg and the same ↔ reproductive parameters: e.g. reproductive organ weights, sperm morphology, sperm counts, testicular NOAEL = 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weights in F0 or F1 females: uterus, ovary, liver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ gr...","duration":"10 weeks","effect":"trogenicity all triclosan doses were also combined with estradiol valerate 2-gen study 10 weeks (F0) and 14-week exposure (F1) Doses: 0.8, 2.4 and 8 mg/kg F0 n = 15-17 F1 n = 12-16 Behavior n = 10 Females: ↔ uterus weight in uterotrophic assay Dams & Offspring: ↔ estrous cyclicity endpoints in F0 or F1 ↔ organ weights in F0 or F1 females: uterus, ovary, liver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ growing follicle number in F1 at 2.4 NOAEL = 8 Pernoncini et al. 2018 Male wistar rats Gavage of 49 day old rats from PND 49- PND140 Doses: 0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher: 0, 0.8, 2.4 and 8.0 mg/kg and the same ↔ reproductive parameters: e.g. reproductive organ weights, sperm morphology, sperm counts, testicular NOAEL = 8","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8.0","page":76,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_065"} |
| Regulatory source |
reproductive toxicity |
8 |
mg/kg |
rat |
oral |
49 day |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8.0; DOSE=0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher:; EFFECT=ver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ growing follicle number in F1 at 2.4 NOAEL = 8 Pernoncini et al. 2018 Male wistar rats Gavage of 49 day old rats from PND 49- PND140 Doses: 0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher: 0, 0.8, 2.4 and 8.0 mg/kg and the same ↔ reproductive parameters: e.g. reproductive organ weights, sperm morphology, sperm counts, testicular NOAEL = 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher:","duration":"49 day","effect":"ver - ↓ perimetrium thickness in F0 at 8 ↔ relative AGD (F1 and F2 female pups), vaginal opening and first estrus (F1) ↓ growing follicle number in F1 at 2.4 NOAEL = 8 Pernoncini et al. 2018 Male wistar rats Gavage of 49 day old rats from PND 49- PND140 Doses: 0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher: 0, 0.8, 2.4 and 8.0 mg/kg and the same ↔ reproductive parameters: e.g. reproductive organ weights, sperm morphology, sperm counts, testicular NOAEL = 8","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8.0","page":76,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_066"} |
| Regulatory source |
reproductive toxicity |
8 |
mg/kg |
rat |
oral |
49 day |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=8.0; DOSE=0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher:; EFFECT=Unlabeled table on page 76: Pernoncini et al. | 2018 | Male wistar rats | Gavage of 49 day old rats from PND 49- PND140 Doses: 0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher: 0, 0.8, 2.4 and 8.0 mg/kg and the same | ↔ reproductive parameters: e.g. reproductive organ weights, sperm morphology, sperm counts, testicular | NOAEL = 8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher:","duration":"49 day","effect":"Unlabeled table on page 76: Pernoncini et al. | 2018 | Male wistar rats | Gavage of 49 day old rats from PND 49- PND140 Doses: 0.8, 2.4 and 8.0 mg/kg n = 10/group Hershberger assay in 52 day old rats Doses at ADI and 3 and 10-fold higher: 0, 0.8, 2.4 and 8.0 mg/kg and the same | ↔ reproductive parameters: e.g. reproductive organ weights, sperm morphology, sperm counts, testicular | NOAEL = 8","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"8.0","page":76,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_177"} |
| Regulatory source |
reproductive toxicity |
25 |
mg/kg bw/day |
rat |
- |
28 weeks |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=25; DOSE=Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005).; EFFECT=tistically significant associations were observed for the reproductive hormones except a negative association between triclocarban and SHBG at 24–28 weeks of gestation. Ref.: Aker 2019 SCCS comment on in vivo animal and human data for triclocarban The SCCS considers that the health effects observed in Costa et al. studies (2020a and 2020b) cannot be regarded as adverse and will not be used to derive a PoD. Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005). The SCCS, will use a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats. The human studies do not provide robust evidence of endocrine disruptive effects of triclocarban. 3.4.3.5 Endocrine activity of triclosan: In vivo animal data (Level 3) Animal studies published after the previous SCCS Opinion on triclosan from; CITATION=Ref.: Aker 2019 SCCS comment on in vivo animal and human data for triclocarban The SCCS considers that the health effects observed in Costa et al; CITATION_NUMBERS=[2019]; REFERENCE=Ref.: Aker 2019 SCCS comment on in vivo animal and human data for triclocarban The SCCS considers that the health effects observed in Costa et al; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: Aker 2019 SCCS comment on in vivo animal and human data for triclocarban The SCCS considers that the health effects observed in Costa et al","dose":"Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005).","duration":"28 weeks","effect":"tistically significant associations were observed for the reproductive hormones except a negative association between triclocarban and SHBG at 24–28 weeks of gestation. Ref.: Aker 2019 SCCS comment on in vivo animal and human data for triclocarban The SCCS considers that the health effects observed in Costa et al. studies (2020a and 2020b) cannot be regarded as adverse and will not be used to derive a PoD. Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005). The SCCS, will use a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats. The human studies do not provide robust evidence of endocrine disruptive effects of triclocarban. 3.4.3.5 Endocrine activity of triclosan: In vivo animal data (Level 3) Animal studies published after the previous SCCS Opinion on triclosan from","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":25,"route":"","species":"rat","study_id":"sccs_o_265_noael_018"} |
| Regulatory source |
reproductive toxicity |
25 |
mg/kg bw/day |
rat |
oral |
2-year |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=25; DOSE=Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005).; EFFECT=SCCS has noted that triclocarban is a weak skin irritant but not an eye irritant. Data show no evidence of skin sensitisation or photoallergenicity. Triclocarban has been found to have a low acute oral, dermal and intraperitoneal toxicity. The SCCS considers that the reproductive effects observed in Costa et al. studies (2020a and 2020b) cannot be regarded as adverse and will not be used to derive a PoD. Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005). The SCCS, will use a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats. In a 2-year chronic feeding study in rats (at doses of 25, 75, and 250 mg/kg bw/d), a decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) were observed in the mid-dose group of 75 mg/kg bw/d. The SCCS selected a PoD; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005).","duration":"2-year","effect":"SCCS has noted that triclocarban is a weak skin irritant but not an eye irritant. Data show no evidence of skin sensitisation or photoallergenicity. Triclocarban has been found to have a low acute oral, dermal and intraperitoneal toxicity. The SCCS considers that the reproductive effects observed in Costa et al. studies (2020a and 2020b) cannot be regarded as adverse and will not be used to derive a PoD. Since none of the other new studies report on adverse effects, including endocrine activity, that indicate a NOEL of lower than 25 mg/kg bw/day that was used in the SCCP opinion (2005). The SCCS, will use a PoD of 25 mg/kg bw/day for triclocarban based on a decrease in food consumption, body weights, and organ weights (e.g. liver, spleen) from a 2-year chronic feeding study in rats. In a 2-year chronic feeding study in rats (at doses of 25, 75, and 250 mg/kg bw/d), a decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) were observed in the mid-dose group of 75 mg/kg bw/d. The SCCS selected a PoD","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":59,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_048"} |
| Regulatory source |
reproductive toxicity |
50 |
mg/kg bw |
- |
- |
2-year |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=50; DOSE=000 ppm revealed effects in the spleen, liver, kidneys and bone marrow.; EFFECT=000 ppm revealed effects in the spleen, liver, kidneys and bone marrow. Histopathology examinations of target organs were not conducted at dose levels below 3000 ppm as these were evaluated in an earlier 2-year chronic feeding study (Monsanto, 1981). Ref.: 22 In conclusion, signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw. The no observed adverse effects level (i.e., NOAEL) for reproductive and developmental toxicity were determined to be 3000 ppm (i.e., approximately 280 mg/kg/d) for the F0 generation, 1000 ppm (i.e., approximately 95 mg/kg/d) for the F1 generation and 3000 ppm (i.e., approximately 300 mg/kg/d) for the F2 generation. Although the study did not follow GLP or OECD guidelines, it was described in sufficient detail and met generally accepted scientific methods (Monsanto, 1983). Ref.: 23 Other studies Nolen and Dierckman (1979) studied the reproductive toxicity of a; CITATION=Ref.: 22 In conclusion, signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a d; CITATION_NUMBERS=[22,500]; REFERENCE=Ref.: 22 In conclusion, signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a d; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 22 In conclusion, signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a d","dose":"000 ppm revealed effects in the spleen, liver, kidneys and bone marrow.","duration":"2-year","effect":"000 ppm revealed effects in the spleen, liver, kidneys and bone marrow. Histopathology examinations of target organs were not conducted at dose levels below 3000 ppm as these were evaluated in an earlier 2-year chronic feeding study (Monsanto, 1981). Ref.: 22 In conclusion, signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw. The no observed adverse effects level (i.e., NOAEL) for reproductive and developmental toxicity were determined to be 3000 ppm (i.e., approximately 280 mg/kg/d) for the F0 generation, 1000 ppm (i.e., approximately 95 mg/kg/d) for the F1 generation and 3000 ppm (i.e., approximately 300 mg/kg/d) for the F2 generation. Although the study did not follow GLP or OECD guidelines, it was described in sufficient detail and met generally accepted scientific methods (Monsanto, 1983). Ref.: 23 Other studies Nolen and Dierckman (1979) studied the reproductive toxicity of a","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":25,"route":"","species":"","study_id":"sccp_o_016_noael_013"} |
| Regulatory source |
reproductive toxicity |
75 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=75; DOSE=ning Triclocarban at doses of 25, 75, and 250 mg/kg bw/d.; EFFECT=ning Triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive and developmental toxicity The reproductive and developmental toxicity of Triclocarban was evaluated in a three generation study in rats. At least 60 days before mating and continuously thereafter, Triclocarban was administered to male and female rats at dietary levels of 0, 250, 500, 1000, and 3000 ppm which reflect a maximum dose-range of 20 mg/kg bw/d to 280 mg/kg/d. Signs of systemic toxicity such; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"ning Triclocarban at doses of 25, 75, and 250 mg/kg bw/d.","duration":"developmental","effect":"ning Triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive and developmental toxicity The reproductive and developmental toxicity of Triclocarban was evaluated in a three generation study in rats. At least 60 days before mating and continuously thereafter, Triclocarban was administered to male and female rats at dietary levels of 0, 250, 500, 1000, and 3000 ppm which reflect a maximum dose-range of 20 mg/kg bw/d to 280 mg/kg/d. Signs of systemic toxicity such","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":34,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_020"} |
| Regulatory source |
reproductive toxicity |
75 |
mg/kg bw/d |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=75; DOSE=ning triclocarban at doses of 25, 75, and 250 mg/kg bw/d.; EFFECT=ning triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., ap; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"ning triclocarban at doses of 25, 75, and 250 mg/kg bw/d.","duration":"developmental","effect":"ning triclocarban at doses of 25, 75, and 250 mg/kg bw/d. At the highest administered dose, the investigators observed a reduction in food consumption, mean body weight and some changes in organ weights and the blood chemistry (i.e., increases in alkaline phosphatase, blood urea nitrogen, glucose, and bilirubin at various time points in the male animals). Decrease in food consumption, body weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., ap","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":15,"route":"","species":"rat","study_id":"sccs_o_265_noael_002"} |
| Regulatory source |
reproductive toxicity |
95 |
mg/kg/day |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=95; EFFECT=Table 8: summary of reproductive and developmental toxicity: (95 mg/kg/day); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: (95 mg/kg/day)","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"95","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_035"} |
| Regulatory source |
reproductive toxicity |
100 |
mg/kg |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=100; EFFECT=Table 8: summary of reproductive and developmental toxicity: (about 100 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: (about 100 mg/kg","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_039"} |
| Regulatory source |
reproductive toxicity |
125 |
mg/kg |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=125; DOSE=Table 8: summary of reproductive and developmental toxicity: teratogenicity | 0.2%, 0.25% | (about 125 mg/kg; EFFECT=Table 8: summary of reproductive and developmental toxicity: teratogenicity | 0.2%, 0.25% | (about 125 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Table 8: summary of reproductive and developmental toxicity: teratogenicity | 0.2%, 0.25% | (about 125 mg/kg","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: teratogenicity | 0.2%, 0.25% | (about 125 mg/kg","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"125","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_038"} |
| Regulatory source |
reproductive toxicity |
280 |
mg/kg/day |
- |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=280; DOSE=Table 8: summary of reproductive and developmental toxicity: dietary feeding | developmental | 1000, 3000 ppm | (280 mg/kg/day) | 1983; EFFECT=Table 8: summary of reproductive and developmental toxicity: dietary feeding | developmental | 1000, 3000 ppm | (280 mg/kg/day) | 1983; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Table 8: summary of reproductive and developmental toxicity: dietary feeding | developmental | 1000, 3000 ppm | (280 mg/kg/day) | 1983","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: dietary feeding | developmental | 1000, 3000 ppm | (280 mg/kg/day) | 1983","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"280","page":23,"route":"oral","species":"","study_id":"sccp_o_016_noael_034"} |
| Regulatory source |
reproductive toxicity |
300 |
mg/kg/day |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=300; EFFECT=Table 8: summary of reproductive and developmental toxicity: (300 mg/kg/day); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: (300 mg/kg/day)","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_036"} |
| Regulatory source |
reproductive toxicity |
300 |
mg/kg |
rat |
oral |
Developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=300; DOSE=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...; EFFECT=SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________71 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Axelstad et al. 2013 Wistar rat Developmental toxicity study with gavage exposure of dams GD7-PND21 Doses: 75, 150 and 300 mg/kg n=10 Study with direct pups dosing PND3-16 at doses of 50 & 150 mg/kg (n=2) Dams: ↓ T4 on GD15 and PND16 at all doses ↔ thyroid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nipple retention, prostate weight T3 and TSH not meas; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________7...","duration":"Developmental","effect":"SCCS/1643/22 Final Scientific Advice Scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products _________________________________________________________________________ ___________________________________________________________________________________________71 Reference Year Species Method Results Comments NOAEL/LOAEL (mg/kg bw/d) Axelstad et al. 2013 Wistar rat Developmental toxicity study with gavage exposure of dams GD7-PND21 Doses: 75, 150 and 300 mg/kg n=10 Study with direct pups dosing PND3-16 at doses of 50 & 150 mg/kg (n=2) Dams: ↓ T4 on GD15 and PND16 at all doses ↔ thyroid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nipple retention, prostate weight T3 and TSH not meas","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":71,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_054"} |
| Regulatory source |
reproductive toxicity |
300 |
mg/kg |
rat |
oral |
Developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=300; DOSE=75, 150 and 300 mg/kg n=10 Study with direct pups dosing PND3-16 at doses of 50 & 150 mg/kg (n=2) | Dams: ↓ T4 on GD15 and PND16 at all doses ↔ thyroid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nippl...; EFFECT=Unlabeled table on page 71: Axelstad et al. | 2013 | Wistar rat | Developmental toxicity study with gavage exposure of dams GD7-PND21 Doses: 75, 150 and 300 mg/kg n=10 Study with direct pups dosing PND3-16 at doses of 50 & 150 mg/kg (n=2) | Dams: ↓ T4 on GD15 and PND16 at all doses ↔ thyroid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nipple retention, prostate weight | T3 and TSH not measured | LOAEL =75; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"75, 150 and 300 mg/kg n=10 Study with direct pups dosing PND3-16 at doses of 50 & 150 mg/kg (n=2) | Dams: ↓ T4 on GD15 and PND16 at all doses ↔ thyroid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nippl...","duration":"Developmental","effect":"Unlabeled table on page 71: Axelstad et al. | 2013 | Wistar rat | Developmental toxicity study with gavage exposure of dams GD7-PND21 Doses: 75, 150 and 300 mg/kg n=10 Study with direct pups dosing PND3-16 at doses of 50 & 150 mg/kg (n=2) | Dams: ↓ T4 on GD15 and PND16 at all doses ↔ thyroid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nipple retention, prostate weight | T3 and TSH not measured | LOAEL =75","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"mg/kg","noael_value":"300","page":71,"route":"oral","species":"rat","study_id":"sccs_o_265_noael_163"} |
| Regulatory source |
reproductive toxicity |
600 |
mg/kg bw/d |
rat |
- |
8 weeks |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT=600; DOSE=0, 10, 50 and 200 mg/kg n = 8/group ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 NOAEL = 10 Feng et al.; LOAEL_VALUE=200 mg/kg; EFFECT=oid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nipple retention, prostate weight T3 and TSH not measured LOAEL =75 Lan et al. 2015 Male Sprague- Dawley rats Intragastric exposure of adult rats for 8 weeks Doses: 0, 10, 50 and 200 mg/kg n = 8/group ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 NOAEL = 10 Feng et al. 2016 Female Sprague- Dawley rats Exposure of pregnant rat dams from GD6 to GD20 Doses: 30, 100, 300 and 600 mg/kg bw/d ↓ uterine weight at 600 ↓ progesterone at all doses ↓ estradiol, No investigations of effects in pups LOAEL = 30 (progesterone); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"0, 10, 50 and 200 mg/kg n = 8/group ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 NOAEL = 10 Feng et al.","duration":"8 weeks","effect":"oid weight Offspring PND16: ↔ T4, thyroid gland histology ↓ T4 in directly exposed pups PND16 at both doses Female offspring: ↔ AGD, nipple retention, reproductive organs Male offspring: ↔ AGD, nipple retention, prostate weight T3 and TSH not measured LOAEL =75 Lan et al. 2015 Male Sprague- Dawley rats Intragastric exposure of adult rats for 8 weeks Doses: 0, 10, 50 and 200 mg/kg n = 8/group ↓ ventral prostate 200 ↓daily sperm production at 50- 200 changes to sperm morphology and epidydimal histopathology at 200 NOAEL = 10 Feng et al. 2016 Female Sprague- Dawley rats Exposure of pregnant rat dams from GD6 to GD20 Doses: 30, 100, 300 and 600 mg/kg bw/d ↓ uterine weight at 600 ↓ progesterone at all doses ↓ estradiol, No investigations of effects in pups LOAEL = 30 (progesterone)","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"200 mg/kg","noael_unit":"mg/kg bw/d","noael_value":"600","page":71,"route":"","species":"rat","study_id":"sccs_o_265_noael_055"} |
| Regulatory source |
reproductive toxicity |
=1000 |
ppm |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 1000; DOSE=ty study in which rats were fed with a diet containing doses of Triclocarban of 3000 and 10000 ppm.; EFFECT=ty study in which rats were fed with a diet containing doses of Triclocarban of 3000 and 10000 ppm. There was not enough information available on this study to evaluate the quality and reliability of the reported study results. Ref.: 44 3.3.8. Reproductive toxicity Table 8: summary of reproductive and developmental toxicity Study type Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26; CITATION=Ref.: 44 3; CITATION_NUMBERS=[44,3]; REFERENCE=Ref.: 44 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 44 3","dose":"ty study in which rats were fed with a diet containing doses of Triclocarban of 3000 and 10000 ppm.","duration":"developmental","effect":"ty study in which rats were fed with a diet containing doses of Triclocarban of 3000 and 10000 ppm. There was not enough information available on this study to evaluate the quality and reliability of the reported study results. Ref.: 44 3.3.8. Reproductive toxicity Table 8: summary of reproductive and developmental toxicity Study type Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"= 1000","page":23,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_009"} |
| Regulatory source |
reproductive toxicity |
>1000 |
mg/kg bw/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=> 1000; DOSE=eference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.:; EFFECT=eference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26; CITATION=Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0; CITATION_NUMBERS=[23,2,1]; REFERENCE=Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0","dose":"eference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.:","duration":"developmental","effect":"eference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"> 1000","page":23,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_012"} |
| Regulatory source |
reproductive toxicity |
=1000 |
ppm |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 1000; EFFECT=Table 8: summary of reproductive and developmental toxicity: toxicity | NOAEL F1 = 1000ppm | Ref.: 23; CITATION=Ref.: 23; CITATION_NUMBERS=[23]; REFERENCE=Ref.: 23; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 23","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: toxicity | NOAEL F1 = 1000ppm | Ref.: 23","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"= 1000","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_029"} |
| Regulatory source |
reproductive toxicity |
>1000 |
mg/kg |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=> 1000; DOSE=Table 8: summary of reproductive and developmental toxicity: mg/kg bw/d | NOEL> 1000 mg/kg; EFFECT=Table 8: summary of reproductive and developmental toxicity: mg/kg bw/d | NOEL> 1000 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Table 8: summary of reproductive and developmental toxicity: mg/kg bw/d | NOEL> 1000 mg/kg","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: mg/kg bw/d | NOEL> 1000 mg/kg","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"> 1000","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_032"} |
| Regulatory source |
reproductive toxicity |
=1000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 1000; DOSE=lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d.; EFFECT=lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding study, there was no evidence for a dose-related increase in tumour incidence and it was concluded that triclocarban was not carcinogenic under the conditions of the study. Hum; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d.","duration":"developmental","effect":"lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding study, there was no evidence for a dose-related increase in tumour incidence and it was concluded that triclocarban was not carcinogenic under the conditions of the study. Hum","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"ppm","noael_value":"= 1000","page":15,"route":"","species":"rat","study_id":"sccs_o_265_noael_005"} |
| Regulatory source |
reproductive toxicity |
=3000 |
ppm |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 3000; DOSE=th a diet containing doses of Triclocarban of 3000 and 10000 ppm.; EFFECT=th a diet containing doses of Triclocarban of 3000 and 10000 ppm. There was not enough information available on this study to evaluate the quality and reliability of the reported study results. Ref.: 44 3.3.8. Reproductive toxicity Table 8: summary of reproductive and developmental toxicity Study type Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26; CITATION=Ref.: 44 3; CITATION_NUMBERS=[44,3]; REFERENCE=Ref.: 44 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: 44 3","dose":"th a diet containing doses of Triclocarban of 3000 and 10000 ppm.","duration":"developmental","effect":"th a diet containing doses of Triclocarban of 3000 and 10000 ppm. There was not enough information available on this study to evaluate the quality and reliability of the reported study results. Ref.: 44 3.3.8. Reproductive toxicity Table 8: summary of reproductive and developmental toxicity Study type Species Endpoint Exposure Result Reference Three generation dietary feeding Rat Reproductive and developmental toxicity 0, 25, 500, 1000, 3000 ppm NOAELp = 3000ppm (280 mg/kg/day) NOAEL F1 = 1000ppm (95 mg/kg/day) NOAEL F2 = 3000ppm (300 mg/kg/day) Monsanto, 1983 Ref.: 23 Reproductive toxicity and teratogenicity Rat and rabbits Endpoints indicative of reproductive toxicity and teratogenicity Mixture TCC:TCF (2:1) Oral: 0.1%, 0.2%, 0.25% Dermal: 250, 500, 1000 mg/kg bw/d LOEL = 0.25% (about 125 mg/kg bw/d) NOEL < 0.2% (about 100 mg/kg bw/d) NOEL> 1000 mg/kg bw/d Nolen and Dierckman , 1979 Ref.: 26","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"= 3000","page":23,"route":"oral","species":"rat","study_id":"sccp_o_016_noael_010"} |
| Regulatory source |
reproductive toxicity |
3000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=3000; DOSE=-range of 20 mg/kg bw/d to 280 mg/kg/d.; EFFECT=-range of 20 mg/kg bw/d to 280 mg/kg/d. Signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw. Under the conditions of the study, the mating indices and the male fertility indices were not adversely affected by treatment in any of the generations. Only the pregnancy rate was observed to be unusually low at 3000 ppm during the second litter interval of the F1 generation. The no observed adverse effect level (i.e., NOAEL) for reproductive and developmental toxicity were determined to be 3000 ppm (i.e., approximately 280 mg/kg/day) for the F0 generation, 1000 ppm (i.e., approximately 95 mg/kg/day) for the F1 generation and 3000 ppm (i.e., approximately 300 mg/kg/day) for the F2 generation. Absorption, distribution, metabolism and excretion (ADME) Pharmacokinetic studies have been carried out with 14C-labeled Triclocarban in various in vitro skin cell systems, and in vivo in rats and in humans. Triclocarban was moderat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"-range of 20 mg/kg bw/d to 280 mg/kg/d.","duration":"developmental","effect":"-range of 20 mg/kg bw/d to 280 mg/kg/d. Signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw. Under the conditions of the study, the mating indices and the male fertility indices were not adversely affected by treatment in any of the generations. Only the pregnancy rate was observed to be unusually low at 3000 ppm during the second litter interval of the F1 generation. The no observed adverse effect level (i.e., NOAEL) for reproductive and developmental toxicity were determined to be 3000 ppm (i.e., approximately 280 mg/kg/day) for the F0 generation, 1000 ppm (i.e., approximately 95 mg/kg/day) for the F1 generation and 3000 ppm (i.e., approximately 300 mg/kg/day) for the F2 generation. Absorption, distribution, metabolism and excretion (ADME) Pharmacokinetic studies have been carried out with 14C-labeled Triclocarban in various in vitro skin cell systems, and in vivo in rats and in humans. Triclocarban was moderat","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":34,"route":"","species":"rat","study_id":"sccp_o_016_noael_021"} |
| Regulatory source |
reproductive toxicity |
3000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT=3000; DOSE=Signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw.; EFFECT=Signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw. Under the conditions of the study, the mating indices and the male fertility indices were not adversely affected by treatment in any of the generations. Only the pregnancy rate was observed to be unusually low at 3000 ppm during the second litter interval of the F1 generation. The no observed adverse effect level (i.e., NOAEL) for reproductive and developmental toxicity were determined to be 3000 ppm (i.e., approximately 280 mg/kg/day) for the F0 generation, 1000 ppm (i.e., approximately 95 mg/kg/day) for the F1 generation and 3000 ppm (i.e., approximately 300 mg/kg/day) for the F2 generation. Absorption, distribution, metabolism and excretion (ADME) Pharmacokinetic studies have been carried out with 14C-labeled Triclocarban in various in vitro skin cell systems, and in vivo in rats and in humans. Triclocarban was moderately absorbed; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"Signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw.","duration":"developmental","effect":"Signs of systemic toxicity such as changes in absolute and relative organ levels were observed in the adult generations at dose levels above 500 ppm equalling a daily exposure of about 50 mg/kg bw. Under the conditions of the study, the mating indices and the male fertility indices were not adversely affected by treatment in any of the generations. Only the pregnancy rate was observed to be unusually low at 3000 ppm during the second litter interval of the F1 generation. The no observed adverse effect level (i.e., NOAEL) for reproductive and developmental toxicity were determined to be 3000 ppm (i.e., approximately 280 mg/kg/day) for the F0 generation, 1000 ppm (i.e., approximately 95 mg/kg/day) for the F1 generation and 3000 ppm (i.e., approximately 300 mg/kg/day) for the F2 generation. Absorption, distribution, metabolism and excretion (ADME) Pharmacokinetic studies have been carried out with 14C-labeled Triclocarban in various in vitro skin cell systems, and in vivo in rats and in humans. Triclocarban was moderately absorbed","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":34,"route":"","species":"rat","study_id":"sccp_o_016_noael_022"} |
| Regulatory source |
reproductive toxicity |
=3000 |
ppm |
- |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 3000; EFFECT=Table 8: summary of reproductive and developmental toxicity: NOAEL F2 = 3000ppm; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: NOAEL F2 = 3000ppm","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"= 3000","page":23,"route":"","species":"","study_id":"sccp_o_016_noael_030"} |
| Regulatory source |
reproductive toxicity |
=3000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_016; REPORT_TITLE=Opinion on Triclocarban For other uses than as a preservative COLIPA n° P29; OPINION_NUMBER=SCCP/0851/04; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=1 June 2005; VALUE_TEXT== 3000; EFFECT=Table 8: summary of reproductive and developmental toxicity: Three generation | Rat | Reproductive and | 0, 25, 500, | NOAELp = 3000ppm | Monsanto,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"","duration":"developmental","effect":"Table 8: summary of reproductive and developmental toxicity: Three generation | Rat | Reproductive and | 0, 25, 500, | NOAELp = 3000ppm | Monsanto,","endpoint":"reproductive toxicity","ingredient":"Triclocarban (INCI name)","loael_value":"","noael_unit":"ppm","noael_value":"= 3000","page":23,"route":"","species":"rat","study_id":"sccp_o_016_noael_033"} |
| Regulatory source |
reproductive toxicity |
=3000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 3000; DOSE=y weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d.; EFFECT=y weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"y weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d.","duration":"developmental","effect":"y weights, and organ weights (e.g., liver, spleen) were also observed in the animals in the mid dose group of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding s","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"ppm","noael_value":"= 3000","page":15,"route":"","species":"rat","study_id":"sccs_o_265_noael_003"} |
| Regulatory source |
reproductive toxicity |
=3000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 3000; DOSE=The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d.; EFFECT=of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding study, there was no evidence for a dose-related increase in tumour incidence and it was concluded that tricl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"101-20-2","citation":"","dose":"The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d.","duration":"developmental","effect":"of 75 mg/kg bw/d. The NOEL was established at 25 mg/kg bw/d and the lowest observed effect level (i.e., LOEL) at 75 mg/kg bw/d. Reproductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding study, there was no evidence for a dose-related increase in tumour incidence and it was concluded that tricl","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"ppm","noael_value":"= 3000","page":15,"route":"","species":"rat","study_id":"sccs_o_265_noael_004"} |
| Regulatory source |
reproductive toxicity |
=3000 |
ppm |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_265; REPORT_TITLE=Final Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of triclocarban and triclosan as substances with potential endocrine disrupting properties in cosmetic products; OPINION_NUMBER=SCCS/1643/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2022; VALUE_TEXT== 3000; DOSE=F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day);; EFFECT=ductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding study, there was no evidence for a dose-related increase in tumour incidence and it was concluded that triclocarban was not carcinogenic under the conditions of the study. Human data / Ref.: SCCP 2005 3.4.2 Toxicological evaluation of triclo; CITATION=Ref.: SCCP 2005 3; CITATION_NUMBERS=[2005,3]; REFERENCE=Ref.: SCCP 2005 3; DETAILS_JSON={"cas_number":"101-20-2","citation":"Ref.: SCCP 2005 3","dose":"F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day);","duration":"developmental","effect":"ductive/developmental Toxicity Triclocarban may affect the reproductive function of males (fertility and/or male sexual behaviour) and females (pre-implantation and/or implantation development) and cause adverse effects on the offspring via lactation. The SCCP (2005) derived a NOAEL for reproductive and developmental toxicity based on a three-generation study in rats: F0 generation NOAEL = 3000 ppm (i.e., approximately 280 mg/kg/day); F1 generation NOAEL = 1000 ppm (i.e., approximately 95 mg/kg/day; F2 generation NOAEL = 3000 ppm (i.e., approximately 300 mg/kg/day). Mutagenicity / genotoxicity Triclocarban was not found to be mutagenic in the Ames test or clastogenic in the chromosomal aberration test with and without metabolic activation. Carcinogenicity In a two-year rat chronic feeding study, there was no evidence for a dose-related increase in tumour incidence and it was concluded that triclocarban was not carcinogenic under the conditions of the study. Human data / Ref.: SCCP 2005 3.4.2 Toxicological evaluation of triclo","endpoint":"reproductive toxicity","ingredient":"s with potential endocrine disrupting properties in","loael_value":"","noael_unit":"ppm","noael_value":"= 3000","page":15,"route":"","species":"rat","study_id":"sccs_o_265_noael_006"} |