codes .............................................. 8, s, toys, textiles, clothing,, Homosalate

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=0.5; DOSE=MoS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) Adjuste d NOAEL (mg/kg bw/day ) MoS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 10 222 Face cream 10 Face 0.136 0 0 0.136 10 74 Hand cream 10 Hand 0.191 0 0 0.191 10 52; EFFECT=creen product, face cream and hand cream containing homosalate, the total applied amount (A) of cosmetic product is 21.7 g/d. With the above values, C is 0.5, meaning the safe level is maximally 0.5% homosalate when used in sunscreen, hand cream and face cream. MoS calculations for separate product types and aggregated exposures are shown in Table 9. Table 9: MoS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) Adjuste d NOAEL (mg/kg bw/day ) MoS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 10 222 Face cream 10 Face 0.136 0 0 0.136 10 74 Hand cream 10 Hand 0.191 0 0 0.191 10 52; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"MoS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) Adjuste d NOAEL (mg/kg bw/day ) MoS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 10 222 Face cream 10 Face 0.136 0 0 0.136 10 74 Hand cream 10 Hand 0.191 0 0 0.191 10 52","duration":"","effect":"creen product, face cream and hand cream containing homosalate, the total applied amount (A) of cosmetic product is 21.7 g/d. With the above values, C is 0.5, meaning the safe level is maximally 0.5% homosalate when used in sunscreen, hand cream and face cream. MoS calculations for separate product types and aggregated exposures are shown in Table 9. Table 9: MoS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) Adjuste d NOAEL (mg/kg bw/day ) MoS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 10 222 Face cream 10 Face 0.136 0 0 0.136 10 74 Hand cream 10 Hand 0.191 0 0 0.191 10 52","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"%","noael_value":"0.5","page":48,"route":"oral","species":"","study_id":"sccs_o_244_noael_011"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=unclear:Table 9: MoS calculations for the different product types and aggregated exposures: NOAEL/LOAEL ad | justm | ent | 20 m | g | /kg bw/d; EFFECT=Table 9: MoS calculations for the different product types and aggregated exposures: NOAEL/LOAEL ad | justm | ent | 20 m | g | /kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"","duration":"","effect":"Table 9: MoS calculations for the different product types and aggregated exposures: NOAEL/LOAEL ad | justm | ent | 20 m | g | /kg bw/d","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 9: MoS calculations for the different product types and aggregated exposures: NOAEL/LOAEL ad | justm | ent | 20 m | g | /kg bw/d","page":48,"route":"","species":"","study_id":"sccs_o_244_noael_014"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=75; DOSE=Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d).","duration":"","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the safety assessment of homosalate (60 mg/kg bw/d). 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) The calculation of the systemic exposure dose (SED) was carried out as laid down in the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF TH","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"75","page":47,"route":"","species":"human","study_id":"sccs_o_244_noael_006"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=75; DOSE=Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d).; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d). The SCCS assessment did not cover the safety of homosalate for the environment.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d).","duration":"","effect":"endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. It was brought up during the commenting period that homosalate is metabolized to e.g. salicylic acid which is considered as endocrine disruptor by the Danish EPA. However, salicylic acid is not the only metabolite formed from homosalate (see chapter on toxicokinetics above). Furthermore, in its Opinion on Salicylic acid (SCCS/1601/18), the SCCS derived an NOAEL of 75 mg/kg bw/d as point of departure for risk assessment, which is higher than the LOAEL currently used by the SCCS for the assessment of homosalate (60 mg/kg bw/d). The SCCS assessment did not cover the safety of homosalate for the environment.","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"75","page":51,"route":"","species":"human","study_id":"sccs_o_244_noael_013"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=100; DOSE=treatment-related findings at any dose level.; EFFECT=treatment-related findings at any dose level. Increases in APTT and/or PT were observed in males at >300 mg/kg bw and in females at 1000 mg/kg bw. Bilirubin was reduced at >100 mg/kg bw in males and at >300 mg/kg bw in females, while triglycerides were increased in both sexes at 1000 mg/kg bw. However, these effects were considered as not adverse (Bilirubin) or only potentially adverse (triglycerides) by the author (no data or further information supplied). Conclusion The author assumed a No Adverse Effect Level (NOAEL) of 100 mg/kg bw for repeated application in rats over a period of 14 days due to the effects on coagulation in males at >300 mg/kg bw and in females at 1000 mg/kg bw. Ref.: 42; CITATION=Ref.: 42; CITATION_NUMBERS=[42]; REFERENCE=Ref.: 42; DETAILS_JSON={"cas_number":"118-56-9","citation":"Ref.: 42","dose":"treatment-related findings at any dose level.","duration":"14 days","effect":"treatment-related findings at any dose level. Increases in APTT and/or PT were observed in males at >300 mg/kg bw and in females at 1000 mg/kg bw. Bilirubin was reduced at >100 mg/kg bw in males and at >300 mg/kg bw in females, while triglycerides were increased in both sexes at 1000 mg/kg bw. However, these effects were considered as not adverse (Bilirubin) or only potentially adverse (triglycerides) by the author (no data or further information supplied). Conclusion The author assumed a No Adverse Effect Level (NOAEL) of 100 mg/kg bw for repeated application in rats over a period of 14 days due to the effects on coagulation in males at >300 mg/kg bw and in females at 1000 mg/kg bw. Ref.: 42","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":27,"route":"","species":"rat","study_id":"sccs_o_244_noael_002"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=120; DOSE=Additional information received in 2021 Physiologically based pharmacokinetic (PBPK) modelling A PBPK model has been developed (Najjar 2021) in order to determine the human internal dose that would correspond to the animal internal systemic dose at an oral external dose of 120 mg/kg bw/d, i.e. the dose level selected as NOAEL by the Applicant.; EFFECT=aximum plasma concentrations of homosalate after topical application varied between 13.9 and 23.1 ng/ml and terminal half-lives varied between 46.9 and 78.4 h in an explorative study (Ref. 50). Additional information received in 2021 Physiologically based pharmacokinetic (PBPK) modelling A PBPK model has been developed (Najjar 2021) in order to determine the human internal dose that would correspond to the animal internal systemic dose at an oral external dose of 120 mg/kg bw/d, i.e. the dose level selected as NOAEL by the Applicant. Based on in vivo studies performed in rats (Kim et al., 2014, experimental phase was during 2013; the Applicant takes responsibility that the experimental in vivo phase of the study took place before animal testing ban (11 March 2013 for toxicokinetics)), an in vivo rat PBPK model has been calibrated for the intravenous (i.v.) route and Cmax. Data from the i.v. route in rats was extrapolated to the oral route in order to calculate Cmax and AUC that would result from an oral dose of 120 mg/kg bw/d; CITATION=(Ref. 50); CITATION_NUMBERS=[50]; REFERENCE=(Ref. 50); DETAILS_JSON={"cas_number":"118-56-9","citation":"(Ref. 50)","dose":"Additional information received in 2021 Physiologically based pharmacokinetic (PBPK) modelling A PBPK model has been developed (Najjar 2021) in order to determine the human internal dose that would correspond to the animal internal systemic dose at an oral external dose of 120 mg/kg bw/d, i.e. the dose level selected as NOAEL by the Applicant.","duration":"","effect":"aximum plasma concentrations of homosalate after topical application varied between 13.9 and 23.1 ng/ml and terminal half-lives varied between 46.9 and 78.4 h in an explorative study (Ref. 50). Additional information received in 2021 Physiologically based pharmacokinetic (PBPK) modelling A PBPK model has been developed (Najjar 2021) in order to determine the human internal dose that would correspond to the animal internal systemic dose at an oral external dose of 120 mg/kg bw/d, i.e. the dose level selected as NOAEL by the Applicant. Based on in vivo studies performed in rats (Kim et al., 2014, experimental phase was during 2013; the Applicant takes responsibility that the experimental in vivo phase of the study took place before animal testing ban (11 March 2013 for toxicokinetics)), an in vivo rat PBPK model has been calibrated for the intravenous (i.v.) route and Cmax. Data from the i.v. route in rats was extrapolated to the oral route in order to calculate Cmax and AUC that would result from an oral dose of 120 mg/kg bw/d","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"120","page":20,"route":"oral","species":"rat","study_id":"sccs_o_244_noael_001"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=300; DOSE=Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption.; EFFECT=SCCS/1622/20 Final Opinion Opinion on homosalate ___________________________________________________________________________________________ ___________________________________________________________________________________________ 30 SCCS comments The full study report of the OECD TG 422 study was made available to the SCCS during the commenting period. Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption.","duration":"","effect":"SCCS/1622/20 Final Opinion Opinion on homosalate ___________________________________________________________________________________________ ___________________________________________________________________________________________ 30 SCCS comments The full study report of the OECD TG 422 study was made available to the SCCS during the commenting period. Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro","endpoint":"","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":30,"route":"","species":"","study_id":"sccs_o_244_noael_003"}

sccs_o_244.pdf

{"dose":"Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption.","effect":"SCCS/1622/20 Final Opinion Opinion on homosalate ___________________________________________________________________________________________ ___________________________________________________________________________________________ 30 SCCS comments The full study report of the OECD TG 422 study was made available to the SCCS during the commenting period. Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro","page":30,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_003"}

sccs_o_244.pdf

{"dose":"Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption.","effect":"SCCS/1622/20 Final Opinion Opinion on homosalate ___________________________________________________________________________________________ ___________________________________________________________________________________________ 30 SCCS comments The full study report of the OECD TG 422 study was made available to the SCCS during the commenting period. Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro","page":30,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_003"}

sccs_o_244.pdf

{"dose":"Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption.","effect":"SCCS/1622/20 Final Opinion Opinion on homosalate ___________________________________________________________________________________________ ___________________________________________________________________________________________ 30 SCCS comments The full study report of the OECD TG 422 study was made available to the SCCS during the commenting period. Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro","page":30,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_003"}

sccs_o_244.pdf

{"dose":"Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption.","effect":"SCCS/1622/20 Final Opinion Opinion on homosalate ___________________________________________________________________________________________ ___________________________________________________________________________________________ 30 SCCS comments The full study report of the OECD TG 422 study was made available to the SCCS during the commenting period. Based on this study, the Applicant derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high-dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro","page":30,"pdf":"sccs_o_244.pdf","row_type":"noael_study","study_id":"sccs_o_244_noael_003"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT== 10; DOSE=For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 42...; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=e when used daily in sunscreen lotion is 6.3. For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 422 study, oral, rat) NOAEL/LOAEL adjustment 20 mg/kg bw/d Bioavailability 50% = 10 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 6.3 In order to derive at a MoS of 100, the SED should be maximally 0.1 mg/kg bw meaning that A x 1000 mg/kg x C/100 x Dap/100/60 = 0.1. With the above values, C is 0.63, meaning the safe level is maximally 0.63% homosalate in final product (sunscreen). Although homosalate is mainly reported to be used as a UV filter in sunscreen product, use in other cosmetic products has been reported (Manova, 2012; Danish Environmental Protection Agency, 2015) to occur occasionally. Therefore, the SCCS has also calcul; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 42...","duration":"","effect":"e when used daily in sunscreen lotion is 6.3. For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 422 study, oral, rat) NOAEL/LOAEL adjustment 20 mg/kg bw/d Bioavailability 50% = 10 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 6.3 In order to derive at a MoS of 100, the SED should be maximally 0.1 mg/kg bw meaning that A x 1000 mg/kg x C/100 x Dap/100/60 = 0.1. With the above values, C is 0.63, meaning the safe level is maximally 0.63% homosalate in final product (sunscreen). Although homosalate is mainly reported to be used as a UV filter in sunscreen product, use in other cosmetic products has been reported (Manova, 2012; Danish Environmental Protection Agency, 2015) to occur occasionally. Therefore, the SCCS has also calcul","endpoint":"dermal absorption","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"= 10","page":48,"route":"oral","species":"rat","study_id":"sccs_o_244_noael_010"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=20; DOSE=For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 42...; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=tomed human skin, in vitro, Finlayson (2021)]. Considering only dermal exposure the MoS for homosalate when used daily in sunscreen lotion is 6.3. For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 422 study, oral, rat) NOAEL/LOAEL adjustment 20 mg/kg bw/d Bioavailability 50% = 10 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 6.3 In order to derive at a MoS of 100, the SED should be maximally 0.1 mg/kg bw meaning that A x 1000 mg/kg x C/100 x Dap/100/60 = 0.1. With the above values, C is 0.63, meaning the safe level is maximally 0.63% homosalate in final product (sunscreen). Although homosalate is mainly reported to be used as a UV filter in sunscreen product, use in other cosmetic products has been reported (Manova, 2012; D; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 42...","duration":"","effect":"tomed human skin, in vitro, Finlayson (2021)]. Considering only dermal exposure the MoS for homosalate when used daily in sunscreen lotion is 6.3. For use as UV-filter in sunscreens Amount of sunscreen applied A (g/d) = 18 Concentration in the finished product C (%) = 10% Dermal Absorption Dap (%) = 5.3% Typical bodyweight of human = 60kg Systemic exposure dose (SED) A x 1000 mg/kg x C/100 x Dap/100/60 = = 1.59 mg/kg bw Lowest observed adverse effect level LOAEL = 60 mg/kg bw/d (OECD TG 422 study, oral, rat) NOAEL/LOAEL adjustment 20 mg/kg bw/d Bioavailability 50% = 10 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 6.3 In order to derive at a MoS of 100, the SED should be maximally 0.1 mg/kg bw meaning that A x 1000 mg/kg x C/100 x Dap/100/60 = 0.1. With the above values, C is 0.63, meaning the safe level is maximally 0.63% homosalate in final product (sunscreen). Although homosalate is mainly reported to be used as a UV filter in sunscreen product, use in other cosmetic products has been reported (Manova, 2012; D","endpoint":"dermal absorption","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"20","page":48,"route":"oral","species":"rat","study_id":"sccs_o_244_noael_009"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=300; DOSE=d Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (see also section 3.4.4).; EFFECT=d Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (see also section 3.4.4). Males (10/group) were treated with 0, 60, 120, 300 or 750 mg/kg bw/day of homosalate in corn oil, by gavage once daily from 14 days pre-pairing and for a total of 47 days. Females (10/group) were treated with 0, 60, 120, 300 or 750 mg/kg bw/day homosalate in corn oil as vehicle, by gavage, once daily from 14 days pre-pairing and sacrificed on day 4 post-partum. Pups were sacrificed on day 4 post-partum. A NOAEL for general toxicity was established at 300 mg/kg bw/day for both sexes based on maternal effects and developmental toxicity (adverse effects on food consumption and body weights in both sexes and mortality of females noted at higher dose). No indication of any effect on reproduction was noted at the dose levels of 60 and 120 mg/kg bw/day (changes in sperm morphology and sperm motility correlating with reduced weights of prostate and seminal vesicles and increased post-implantation loss were noted at 750 and 300 m; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"d Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (see also section 3.4.4).","duration":"Developmental","effect":"d Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (see also section 3.4.4). Males (10/group) were treated with 0, 60, 120, 300 or 750 mg/kg bw/day of homosalate in corn oil, by gavage once daily from 14 days pre-pairing and for a total of 47 days. Females (10/group) were treated with 0, 60, 120, 300 or 750 mg/kg bw/day homosalate in corn oil as vehicle, by gavage, once daily from 14 days pre-pairing and sacrificed on day 4 post-partum. Pups were sacrificed on day 4 post-partum. A NOAEL for general toxicity was established at 300 mg/kg bw/day for both sexes based on maternal effects and developmental toxicity (adverse effects on food consumption and body weights in both sexes and mortality of females noted at higher dose). No indication of any effect on reproduction was noted at the dose levels of 60 and 120 mg/kg bw/day (changes in sperm morphology and sperm motility correlating with reduced weights of prostate and seminal vesicles and increased post-implantation loss were noted at 750 and 300 m","endpoint":"developmental toxicity","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":31,"route":"oral","species":"","study_id":"sccs_o_244_noael_004"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=10; DOSE=t of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1).; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=t of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1). Since the point of departure is based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information or oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"t of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1).","duration":"Developmental","effect":"t of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1). Since the point of departure is based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information or oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day.","endpoint":"repeated dose toxicity","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/day","noael_value":"10","page":47,"route":"oral","species":"","study_id":"sccs_o_244_noael_008"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=50; DOSE=CALCULATION OF THE SYSTEMIC EXPOSURE DOSE As point of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1).; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=osmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF THE SYSTEMIC EXPOSURE DOSE As point of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1). Since the point of departure is based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information or oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"CALCULATION OF THE SYSTEMIC EXPOSURE DOSE As point of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1).","duration":"Developmental","effect":"osmetic Ingredients and their Safety Evaluation, 11th revision, adopted during the plenary meeting of 30-31 March 2021 (SCCS/1628/21). CALCULATION OF THE SYSTEMIC EXPOSURE DOSE As point of departure for risk assessment, a LOAEL of 60 mg/kg bw/d, based on a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was used (see section 3.4.4.1). Since the point of departure is based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information or oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day.","endpoint":"repeated dose toxicity","ingredient":"codes .............................................. 8","loael_value":"60 mg/kg bw/d","noael_unit":"%","noael_value":"50","page":47,"route":"oral","species":"","study_id":"sccs_o_244_noael_007"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=300; DOSE=Repeated dose toxicity The full study report of an OECD TG 422 study (1996 version) was made available to the SCCS during the commenting period.; EFFECT=itation of homosalate when used in concentrations up to 10% in sunscreen formulations. Skin sensitisation The SCCS agrees with the French RMOA (ANSES 2018) that overall, homosalate does not present any concern for skin sensitisation considering the above data. Acute toxicity Homosalate is of low acute oral and dermal toxicity. Repeated dose toxicity The full study report of an OECD TG 422 study (1996 version) was made available to the SCCS during the commenting period. Based on this study, the authors derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"Repeated dose toxicity The full study report of an OECD TG 422 study (1996 version) was made available to the SCCS during the commenting period.","duration":"","effect":"itation of homosalate when used in concentrations up to 10% in sunscreen formulations. Skin sensitisation The SCCS agrees with the French RMOA (ANSES 2018) that overall, homosalate does not present any concern for skin sensitisation considering the above data. Acute toxicity Homosalate is of low acute oral and dermal toxicity. Repeated dose toxicity The full study report of an OECD TG 422 study (1996 version) was made available to the SCCS during the commenting period. Based on this study, the authors derived a NOAEL of 300 mg/kg bw/day for general toxicity based on mortality in high dose females and decreased food consumption. However, it should be noted that at this dose, effects on kidneys, liver, thyroid and thymus had already occurred. In male animals, histopathological kidney findings which occurred from the lowest dose level were stated to be attributed to hyaline droplet nephropathy but no scientific data was provided to underline this statement. It is of note that in males, higher kidney weights were also observed fro","endpoint":"repeated dose toxicity","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":50,"route":"oral","species":"","study_id":"sccs_o_244_noael_012"}

sccs_o_244.pdf

SOURCE_SUBDIR=sccs_o_244; REPORT_TITLE=OPINION on Homosalate; OPINION_NUMBER=SCCS/1622/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2021; VALUE_TEXT=300; DOSE=(adverse effects on food consumption and body weights in both sexes and mortality of females noted at higher dose).; EFFECT=(adverse effects on food consumption and body weights in both sexes and mortality of females noted at higher dose). No indication of any effect on reproduction was noted at the dose levels of 60 and 120 mg/kg bw/day (changes in sperm morphology and sperm motility correlating with reduced weights of prostate and seminal vesicles and increased post-implantation loss were noted at 750 and 300 mg/kg/day). However, because of low numbers of pregnant females, none of these dose levels could be conclusively confirmed as NOAEL. The possible effects on fertility (increased infertility, sperm changes), development (higher post-implantation loss) and thyroid (hypertrophy of the follicular epithelium) noted in this study cannot be considered as conclusive and reliable due to a technical error that maintained the animals under a constant light. Significant changes in sperm morphology (reduced number of normal complete sperm, increased number of sperm with normal head only and detached tail and of sperm with abnormal head and normal tail) and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"(adverse effects on food consumption and body weights in both sexes and mortality of females noted at higher dose).","duration":"","effect":"(adverse effects on food consumption and body weights in both sexes and mortality of females noted at higher dose). No indication of any effect on reproduction was noted at the dose levels of 60 and 120 mg/kg bw/day (changes in sperm morphology and sperm motility correlating with reduced weights of prostate and seminal vesicles and increased post-implantation loss were noted at 750 and 300 mg/kg/day). However, because of low numbers of pregnant females, none of these dose levels could be conclusively confirmed as NOAEL. The possible effects on fertility (increased infertility, sperm changes), development (higher post-implantation loss) and thyroid (hypertrophy of the follicular epithelium) noted in this study cannot be considered as conclusive and reliable due to a technical error that maintained the animals under a constant light. Significant changes in sperm morphology (reduced number of normal complete sperm, increased number of sperm with normal head only and detached tail and of sperm with abnormal head and normal tail) and","endpoint":"reproductive toxicity","ingredient":"codes .............................................. 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":31,"route":"","species":"","study_id":"sccs_o_244_noael_005"}

sccs_o_244.pdf

{"absorption_percent":"5.3%","basis":"Ref.: ECHA 2020a, 2020b; Symrise 2002, 2004 3.2 TOXICOKINETICS Taken from SCCS/1622/20 Several in vitro dermal penetration studies using rat and human skin have been performed. For MoS calculation, the SCCS selected a new skin penetration study using human skin from which a dermal absorption of 5.3% (mean + 1SD: 3.86±1.43) was derived. Systemic bioavailability of Homosalate after dermal application was confirmed by the detection of Homosalate in plasma of volunteers after topical application of sunscreen products containing Homosalate but also by the detection of Homosalate human milk samples. Maximum plasma concentrations of Homosalate after topical application varied between 13.9 and 23.1 ng/ml and terminal half-lives varied between 46.9 and 78.4 h in an explorative study. In vitro, Homosalate was hydrolysed into salicylic acid and 3,3,5-trimethylcyclohexanol. In addition, conjugation and hydroxylation of intact Homosalate was observed.","citation":"Ref.: ECHA 2020a, 2020b","page":7,"pdf":"sccs_o_260.pdf","row_type":"dermal_absorption_study"}

sccs_o_260.pdf

{"absorption_percent":"5.3%","basis":"Ref.: ECHA 2020a, 2020b; Symrise 2002, 2004 3.2 TOXICOKINETICS Taken from SCCS/1622/20 Several in vitro dermal penetration studies using rat and human skin have been performed. For MoS calculation, the SCCS selected a new skin penetration study using human skin from which a dermal absorption of 5.3% (mean + 1SD: 3.86±1.43) was derived. Systemic bioavailability of Homosalate after dermal application was confirmed by the detection of Homosalate in plasma of volunteers after topical application of sunscreen products containing Homosalate but also by the detection of Homosalate human milk samples. Maximum plasma concentrations of Homosalate after topical application varied between 13.9 and 23.1 ng/ml and terminal half-lives varied between 46.9 and 78.4 h in an explorative study. In vitro, Homosalate was hydrolysed into salicylic acid and 3,3,5-trimethylcyclohexanol. In addition, conjugation and hydroxylation of intact Homosalate was observed.","citation":"Ref.: ECHA 2020a, 2020b","page":7,"pdf":"sccs_o_260.pdf","row_type":"dermal_absorption_study"}

sccs_o_260.pdf

{"absorption_percent":"5.3%","basis":"Ref.: ECHA 2020a, 2020b; Symrise 2002, 2004 3.2 TOXICOKINETICS Taken from SCCS/1622/20 Several in vitro dermal penetration studies using rat and human skin have been performed. For MoS calculation, the SCCS selected a new skin penetration study using human skin from which a dermal absorption of 5.3% (mean + 1SD: 3.86±1.43) was derived. Systemic bioavailability of Homosalate after dermal application was confirmed by the detection of Homosalate in plasma of volunteers after topical application of sunscreen products containing Homosalate but also by the detection of Homosalate human milk samples. Maximum plasma concentrations of Homosalate after topical application varied between 13.9 and 23.1 ng/ml and terminal half-lives varied between 46.9 and 78.4 h in an explorative study. In vitro, Homosalate was hydrolysed into salicylic acid and 3,3,5-trimethylcyclohexanol. In addition, conjugation and hydroxylation of intact Homosalate was observed.","citation":"Ref.: ECHA 2020a, 2020b","page":7,"pdf":"sccs_o_260.pdf","row_type":"dermal_absorption_study"}

sccs_o_260.pdf

{"dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"f.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this Opinion. 4. CONCLUSION 1. In light of the information provided and taking under consideration the concerns related t","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_005"}

sccs_o_260.pdf

{"dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"f.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this Opinion. 4. CONCLUSION 1. In light of the information provided and taking under consideration the concerns related t","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_005"}

sccs_o_260.pdf

{"dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"f.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this Opinion. 4. CONCLUSION 1. In light of the information provided and taking under consideration the concerns related t","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_005"}

sccs_o_260.pdf

{"dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"f.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this Opinion. 4. CONCLUSION 1. In light of the information provided and taking under consideration the concerns related t","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_005"}

sccs_o_260.pdf

{"citation":"Ref.: SCCS/1622/20 3","dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"ent to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Ref.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) o","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_004"}

sccs_o_260.pdf

{"citation":"Ref.: SCCS/1622/20 3","dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"ent to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Ref.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) o","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_004"}

sccs_o_260.pdf

{"citation":"Ref.: SCCS/1622/20 3","dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"ent to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Ref.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) o","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_004"}

sccs_o_260.pdf

{"citation":"Ref.: SCCS/1622/20 3","dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","effect":"ent to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Ref.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) o","page":10,"pdf":"sccs_o_260.pdf","row_type":"noael_study","study_id":"sccs_o_260_noael_004"}

sccs_o_260.pdf

SOURCE_SUBDIR=sccs_o_260; REPORT_TITLE=Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV-filter in cosmetic products; OPINION_NUMBER=SCCS/1638/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=10; DOSE=SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=f.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this Opinion. 4. CONCLUSION 1. In light of the information provided and taking under consideration the concerns related t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-56-9","citation":"","dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","duration":"developmental","effect":"f.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) or directly from salicylic acid itself has not been considered in this Opinion. 4. CONCLUSION 1. In light of the information provided and taking under consideration the concerns related t","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"60 mg/kg bw/d","noael_unit":"mg/kg bw/day","noael_value":"10","page":10,"route":"oral","species":"","study_id":"sccs_o_260_noael_005"}

sccs_o_260.pdf

SOURCE_SUBDIR=sccs_o_260; REPORT_TITLE=Scientific Advice Scientific Committee on Consumer Safety SCCS SCIENTIFIC ADVICE ON the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV-filter in cosmetic products; OPINION_NUMBER=SCCS/1638/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 2 December 2021; VALUE_TEXT=50; DOSE=SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.; LOAEL_VALUE=60 mg/kg bw/d; EFFECT=ent to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Ref.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) o; CITATION=Ref.: SCCS/1622/20 3; CITATION_NUMBERS=[1622,20,3]; REFERENCE=Ref.: SCCS/1622/20 3; DETAILS_JSON={"cas_number":"118-56-9","citation":"Ref.: SCCS/1622/20 3","dose":"SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used.","duration":"developmental","effect":"ent to regard it as an endocrine disrupting substance, or to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Ref.: SCCS/1622/20 3.5 SAFETY EVALUATION In SCCS/1622/20, a LOAEL of 60 mg/kg bw/d, based on a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD Guideline 422) was used. Since the point of departure was based on a LOAEL, an assessment factor of 3 was added to account for LOAEL-NOAEL extrapolation. Furthermore, due to lack of information on oral bioavailability, 50% of the administered dose was used as the default oral absorption value, resulting in an adjusted NOAEL of 10 mg/kg bw/day. Product Exposure route NOAELadj (mg/kg bw/day) SED MoS Face cream Dermal 10 0.0998 100.2 Face pump spray Dermal + inhalation 10 0.0999 100.1 NOAELadj: Adjusted NOAEL value Combined exposure to salicylic acid either formed by metabolic transformation from Homosalate, other salicylates (e.g. methylsalicylate) o","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"60 mg/kg bw/d","noael_unit":"%","noael_value":"50","page":10,"route":"oral","species":"human","study_id":"sccs_o_260_noael_004"}

sccs_o_260.pdf