NOAEL Studies
Cosmetic Ingredient
Benzethonium Chloride NOAEL Studies
INCI: BENZETHONIUM CHLORIDE
CAS: 121-54-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP_ICE_acute_oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =368 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_1660; row=10202; data_type=In Vivo; mixture=Chemical; chemical_name=Benzethonium chloride; preferred_name=Benzethonium chloride; dtxsid=DTXSID6023810; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6023810; source_file=acute_oral.xlsx |
NTP_ICE_cancer 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_cancer | Top dose | 1.5 | mg/kg | Rat | Dermal | - | In Vivo; NTP Carcinogenicity | sheet=Data; excel_row=6937; Record_ID=cancer_6137; Data_Type=In Vivo; Formulation_Name=Benzethonium Chloride; Mixture=Chemical; DTXSID=DTXSID6023810; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=1.5; Response_Unit=mg/kg; Species=Rat; Strain=F344/N; Sex=Female; Route=Dermal; Reference=TR-438; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr438/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6023810 |
NTP_ICE_eye_irritation 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 67 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1806; Record_ID=eye_irritation_160; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID6023810; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=67; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6023810 |
| NTP_ICE_eye_irritation | GHS Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1800; Record_ID=eye_irritation_37; Data_Type=In Vivo; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6023810; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=GHS Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=ICCVAM 2006; URL=https://ntp.niehs.nih.gov/sites/default/files/iccvam/docs/ocutox_docs/oteval/otevalrpt.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6023810 |
| NTP_ICE_eye_irritation | Intensity | 0.38 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1801; Record_ID=eye_irritation_1298; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6023810; Assay=Vitrigel; Endpoint=Intensity; Response=0.38; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6023810 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1805; Record_ID=eye_irritation_1298; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6023810; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6023810 |
| NTP_ICE_eye_irritation | Plateau level | 68.3 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1804; Record_ID=eye_irritation_1298; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6023810; Assay=Vitrigel; Endpoint=Plateau level; Response=68.3; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6023810; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6023810 |
SCCNFP_vision_codex 48 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =0.014 | mg/kg bw/day | rat | - | - | dermal absorption | {"dose":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. I","page":10,"pdf":"out250_en.pdf","row_type":"noael_study","study_id":"out250_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =0.014 | mg/kg bw/day | rat | - | - | dermal absorption | {"dose":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. I","page":10,"pdf":"out250_en.pdf","row_type":"noael_study","study_id":"out250_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =0.014 | mg/kg bw/day | rat | - | - | dermal absorption | {"dose":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. I","page":10,"pdf":"out250_en.pdf","row_type":"noael_study","study_id":"out250_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =0.014 | mg/kg bw/day | rat | - | - | dermal absorption | {"dose":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. I","page":10,"pdf":"out250_en.pdf","row_type":"noael_study","study_id":"out250_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | % | rat | dermal | 28-day | repeated dose toxicity | {"citation":"Ref. : 15 2","dose":"The results confirmed most of the changes seen at the top dose, including caecal enlargement.","effect":"___________________________________________________ 5 - A supplementary 28-day study in rats with the same feeding levels was conducted to verify and extend certain findings in the previous study. The results confirmed most of the changes seen at the top dose, including caecal enlargement. The latter finding was not accompanied by histopathological changes. Decreased levels of serum-P seen at the two higher levels in the previous study did not occur in the present study. Therefore, 500 ppm (or 40 mg/kg bw) was the NOAEL in the supplementary study. Ref. : 15 2.3.3. Repeated dose dermal toxicity Subacute study In a dermal application of 2 ml 0.1 % solution to the skin of rabbits daily, 5 days/week for 4 weeks no systemic effects were observed (Summary Report). In a 16-day study, F 344/N rats (5 males + 5 females/group) received topical applications of a fixed 250 ml volume of ethanol solutions corresponding to 0, 6.3, 12.5, 25, 50 or 100 mg benzethonium chloride/kg bw/day. Animals were treated 5 days per week for a total of 12 dose","page":5,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | % | rat | dermal | 28-day | repeated dose toxicity | {"citation":"Ref. : 15 2","dose":"The results confirmed most of the changes seen at the top dose, including caecal enlargement.","effect":"___________________________________________________ 5 - A supplementary 28-day study in rats with the same feeding levels was conducted to verify and extend certain findings in the previous study. The results confirmed most of the changes seen at the top dose, including caecal enlargement. The latter finding was not accompanied by histopathological changes. Decreased levels of serum-P seen at the two higher levels in the previous study did not occur in the present study. Therefore, 500 ppm (or 40 mg/kg bw) was the NOAEL in the supplementary study. Ref. : 15 2.3.3. Repeated dose dermal toxicity Subacute study In a dermal application of 2 ml 0.1 % solution to the skin of rabbits daily, 5 days/week for 4 weeks no systemic effects were observed (Summary Report). In a 16-day study, F 344/N rats (5 males + 5 females/group) received topical applications of a fixed 250 ml volume of ethanol solutions corresponding to 0, 6.3, 12.5, 25, 50 or 100 mg benzethonium chloride/kg bw/day. Animals were treated 5 days per week for a total of 12 dose","page":5,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | % | rat | dermal | 28-day | repeated dose toxicity | {"citation":"Ref. : 15 2","dose":"The results confirmed most of the changes seen at the top dose, including caecal enlargement.","effect":"___________________________________________________ 5 - A supplementary 28-day study in rats with the same feeding levels was conducted to verify and extend certain findings in the previous study. The results confirmed most of the changes seen at the top dose, including caecal enlargement. The latter finding was not accompanied by histopathological changes. Decreased levels of serum-P seen at the two higher levels in the previous study did not occur in the present study. Therefore, 500 ppm (or 40 mg/kg bw) was the NOAEL in the supplementary study. Ref. : 15 2.3.3. Repeated dose dermal toxicity Subacute study In a dermal application of 2 ml 0.1 % solution to the skin of rabbits daily, 5 days/week for 4 weeks no systemic effects were observed (Summary Report). In a 16-day study, F 344/N rats (5 males + 5 females/group) received topical applications of a fixed 250 ml volume of ethanol solutions corresponding to 0, 6.3, 12.5, 25, 50 or 100 mg benzethonium chloride/kg bw/day. Animals were treated 5 days per week for a total of 12 dose","page":5,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | % | rat | dermal | 28-day | repeated dose toxicity | {"citation":"Ref. : 15 2","dose":"The results confirmed most of the changes seen at the top dose, including caecal enlargement.","effect":"___________________________________________________ 5 - A supplementary 28-day study in rats with the same feeding levels was conducted to verify and extend certain findings in the previous study. The results confirmed most of the changes seen at the top dose, including caecal enlargement. The latter finding was not accompanied by histopathological changes. Decreased levels of serum-P seen at the two higher levels in the previous study did not occur in the present study. Therefore, 500 ppm (or 40 mg/kg bw) was the NOAEL in the supplementary study. Ref. : 15 2.3.3. Repeated dose dermal toxicity Subacute study In a dermal application of 2 ml 0.1 % solution to the skin of rabbits daily, 5 days/week for 4 weeks no systemic effects were observed (Summary Report). In a 16-day study, F 344/N rats (5 males + 5 females/group) received topical applications of a fixed 250 ml volume of ethanol solutions corresponding to 0, 6.3, 12.5, 25, 50 or 100 mg benzethonium chloride/kg bw/day. Animals were treated 5 days per week for a total of 12 dose","page":5,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =1 | mg/kg bw/day | rabbit | oral | - | reproductive toxicity | {"citation":"Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m","dose":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance.","effect":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have been observed; the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1 | mg/kg bw/day | rabbit | oral | - | reproductive toxicity | {"citation":"Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m","dose":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance.","effect":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have been observed; the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1 | mg/kg bw/day | rabbit | oral | - | reproductive toxicity | {"citation":"Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m","dose":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance.","effect":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have been observed; the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1 | mg/kg bw/day | rabbit | oral | - | reproductive toxicity | {"citation":"Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m","dose":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance.","effect":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have been observed; the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg bw/day | rat | oral | - | NOAEL study | {"citation":"Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1","dose":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day.","effect":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for maternal toxicity and embryo-toxicity in this study was 3.6 mg/kg bw/day. Ref. : 8 - In a teratogenicity study in Long Evans (20 per Group) rats with oral dosing of 1.1, 3.6 or 35.6 mg/kg bw/day on gestational days 6 to 15 the high-dose group showed decreased maternal body weight and an increased number of smaller pups. An increased incidence of skeletal variants (ossification effects) occurred in all treated groups. Skeletal malformation was increased in the high-dose group. Slight hydrocephalus was seen in o","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg BW/day | - | - | - | NOAEL study | {"dose":"3.6 mg/kg BW/day MOS :","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 15 NOAEL : 3.6 mg/kg BW/day MOS : 40 For use in all types of leave-on cosmetics, the above Margin of Safety is considered unacceptable. 2.12. Opinion The data provided in the submitted dossier does not support the requested use of Benzethonium chloride as a preservative in leave-on products. Its present use as a preservative in rinse-off products at a maximum authorised concentration of 0.1 % is considered safe. 2.13. References 1. De Flora S., Study of 106 organic and inorganic compounds in the Salmonella/microsome test.","page":15,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_014"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg bw/day | rat | oral | - | NOAEL study | {"citation":"Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1","dose":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day.","effect":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for maternal toxicity and embryo-toxicity in this study was 3.6 mg/kg bw/day. Ref. : 8 - In a teratogenicity study in Long Evans (20 per Group) rats with oral dosing of 1.1, 3.6 or 35.6 mg/kg bw/day on gestational days 6 to 15 the high-dose group showed decreased maternal body weight and an increased number of smaller pups. An increased incidence of skeletal variants (ossification effects) occurred in all treated groups. Skeletal malformation was increased in the high-dose group. Slight hydrocephalus was seen in o","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg BW/day | - | - | - | NOAEL study | {"dose":"3.6 mg/kg BW/day MOS :","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 15 NOAEL : 3.6 mg/kg BW/day MOS : 40 For use in all types of leave-on cosmetics, the above Margin of Safety is considered unacceptable. 2.12. Opinion The data provided in the submitted dossier does not support the requested use of Benzethonium chloride as a preservative in leave-on products. Its present use as a preservative in rinse-off products at a maximum authorised concentration of 0.1 % is considered safe. 2.13. References 1. De Flora S., Study of 106 organic and inorganic compounds in the Salmonella/microsome test.","page":15,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_014"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg bw/day | rat | oral | - | NOAEL study | {"citation":"Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1","dose":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day.","effect":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for maternal toxicity and embryo-toxicity in this study was 3.6 mg/kg bw/day. Ref. : 8 - In a teratogenicity study in Long Evans (20 per Group) rats with oral dosing of 1.1, 3.6 or 35.6 mg/kg bw/day on gestational days 6 to 15 the high-dose group showed decreased maternal body weight and an increased number of smaller pups. An increased incidence of skeletal variants (ossification effects) occurred in all treated groups. Skeletal malformation was increased in the high-dose group. Slight hydrocephalus was seen in o","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg BW/day | - | - | - | NOAEL study | {"dose":"3.6 mg/kg BW/day MOS :","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 15 NOAEL : 3.6 mg/kg BW/day MOS : 40 For use in all types of leave-on cosmetics, the above Margin of Safety is considered unacceptable. 2.12. Opinion The data provided in the submitted dossier does not support the requested use of Benzethonium chloride as a preservative in leave-on products. Its present use as a preservative in rinse-off products at a maximum authorised concentration of 0.1 % is considered safe. 2.13. References 1. De Flora S., Study of 106 organic and inorganic compounds in the Salmonella/microsome test.","page":15,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_014"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg bw/day | rat | oral | - | NOAEL study | {"citation":"Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1","dose":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day.","effect":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for maternal toxicity and embryo-toxicity in this study was 3.6 mg/kg bw/day. Ref. : 8 - In a teratogenicity study in Long Evans (20 per Group) rats with oral dosing of 1.1, 3.6 or 35.6 mg/kg bw/day on gestational days 6 to 15 the high-dose group showed decreased maternal body weight and an increased number of smaller pups. An increased incidence of skeletal variants (ossification effects) occurred in all treated groups. Skeletal malformation was increased in the high-dose group. Slight hydrocephalus was seen in o","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3.6 | mg/kg BW/day | - | - | - | NOAEL study | {"dose":"3.6 mg/kg BW/day MOS :","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 15 NOAEL : 3.6 mg/kg BW/day MOS : 40 For use in all types of leave-on cosmetics, the above Margin of Safety is considered unacceptable. 2.12. Opinion The data provided in the submitted dossier does not support the requested use of Benzethonium chloride as a preservative in leave-on products. Its present use as a preservative in rinse-off products at a maximum authorised concentration of 0.1 % is considered safe. 2.13. References 1. De Flora S., Study of 106 organic and inorganic compounds in the Salmonella/microsome test.","page":15,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_014"} |
| SCCNFP_vision_codex | NOAEL | =8 | mg/kg bw/day | rat | oral | Subacute | repeated dose toxicity | {"citation":"Ref. : 14","dose":"at, LD50 = 19 mg/kg 2.3.2.","effect":"at, LD50 = 19 mg/kg 2.3.2. Repeated dose oral toxicity Subacute study - In a 28-day feeding study, rats received diets with 0, 20, 100, 500 or 2500 ppm, providing intake levels of 0, 1.7, 8, 40 or 200 mg/kg bw/day. The changes in the top-dose group included growth retardation, caecum enlargement, signs of liver damage and decreased serum levels of inorganic phosphorus in males. The last finding was the only effect considered treatment-related in males fed 500 ppm. The diet with 100 ppm (8 mg/kg bw/day) was a clear NOAEL. Ref. : 14","page":4,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =8 | mg/kg bw/day | rat | oral | Subacute | repeated dose toxicity | {"citation":"Ref. : 14","dose":"at, LD50 = 19 mg/kg 2.3.2.","effect":"at, LD50 = 19 mg/kg 2.3.2. Repeated dose oral toxicity Subacute study - In a 28-day feeding study, rats received diets with 0, 20, 100, 500 or 2500 ppm, providing intake levels of 0, 1.7, 8, 40 or 200 mg/kg bw/day. The changes in the top-dose group included growth retardation, caecum enlargement, signs of liver damage and decreased serum levels of inorganic phosphorus in males. The last finding was the only effect considered treatment-related in males fed 500 ppm. The diet with 100 ppm (8 mg/kg bw/day) was a clear NOAEL. Ref. : 14","page":4,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =8 | mg/kg bw/day | rat | oral | Subacute | repeated dose toxicity | {"citation":"Ref. : 14","dose":"at, LD50 = 19 mg/kg 2.3.2.","effect":"at, LD50 = 19 mg/kg 2.3.2. Repeated dose oral toxicity Subacute study - In a 28-day feeding study, rats received diets with 0, 20, 100, 500 or 2500 ppm, providing intake levels of 0, 1.7, 8, 40 or 200 mg/kg bw/day. The changes in the top-dose group included growth retardation, caecum enlargement, signs of liver damage and decreased serum levels of inorganic phosphorus in males. The last finding was the only effect considered treatment-related in males fed 500 ppm. The diet with 100 ppm (8 mg/kg bw/day) was a clear NOAEL. Ref. : 14","page":4,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =8 | mg/kg bw/day | rat | oral | Subacute | repeated dose toxicity | {"citation":"Ref. : 14","dose":"at, LD50 = 19 mg/kg 2.3.2.","effect":"at, LD50 = 19 mg/kg 2.3.2. Repeated dose oral toxicity Subacute study - In a 28-day feeding study, rats received diets with 0, 20, 100, 500 or 2500 ppm, providing intake levels of 0, 1.7, 8, 40 or 200 mg/kg bw/day. The changes in the top-dose group included growth retardation, caecum enlargement, signs of liver damage and decreased serum levels of inorganic phosphorus in males. The last finding was the only effect considered treatment-related in males fed 500 ppm. The diet with 100 ppm (8 mg/kg bw/day) was a clear NOAEL. Ref. : 14","page":4,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =35.6 | mg/kg bw/day | rat | oral | - | reproductive toxicity | {"citation":"Ref. : 35 2","dose":"administered at 0.3% did not elicit dermal irritation and/or sensitisation.","effect":"administered at 0.3% did not elicit dermal irritation and/or sensitisation. Ref. : 35 2.6. Teratogenicity Fertility and reproductive performance were examined in rats treated orally with 1.1, 3.6 and 35.6 mg/kg bw/day prior to and during mating and during the gestation and lactation period. The high- dose produced growth depression, increased irritability, respiratory signs in the parents and decreased viability and body weight of pups at birth. Fertility and general reproductive performance were not affected. The NOAEL has to be considered higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =35.6 | mg/kg bw/day | rat | oral | - | reproductive toxicity | {"citation":"Ref. : 35 2","dose":"administered at 0.3% did not elicit dermal irritation and/or sensitisation.","effect":"administered at 0.3% did not elicit dermal irritation and/or sensitisation. Ref. : 35 2.6. Teratogenicity Fertility and reproductive performance were examined in rats treated orally with 1.1, 3.6 and 35.6 mg/kg bw/day prior to and during mating and during the gestation and lactation period. The high- dose produced growth depression, increased irritability, respiratory signs in the parents and decreased viability and body weight of pups at birth. Fertility and general reproductive performance were not affected. The NOAEL has to be considered higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =35.6 | mg/kg bw/day | rat | oral | - | reproductive toxicity | {"citation":"Ref. : 35 2","dose":"administered at 0.3% did not elicit dermal irritation and/or sensitisation.","effect":"administered at 0.3% did not elicit dermal irritation and/or sensitisation. Ref. : 35 2.6. Teratogenicity Fertility and reproductive performance were examined in rats treated orally with 1.1, 3.6 and 35.6 mg/kg bw/day prior to and during mating and during the gestation and lactation period. The high- dose produced growth depression, increased irritability, respiratory signs in the parents and decreased viability and body weight of pups at birth. Fertility and general reproductive performance were not affected. The NOAEL has to be considered higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =35.6 | mg/kg bw/day | rat | oral | - | reproductive toxicity | {"citation":"Ref. : 35 2","dose":"administered at 0.3% did not elicit dermal irritation and/or sensitisation.","effect":"administered at 0.3% did not elicit dermal irritation and/or sensitisation. Ref. : 35 2.6. Teratogenicity Fertility and reproductive performance were examined in rats treated orally with 1.1, 3.6 and 35.6 mg/kg bw/day prior to and during mating and during the gestation and lactation period. The high- dose produced growth depression, increased irritability, respiratory signs in the parents and decreased viability and body weight of pups at birth. Fertility and general reproductive performance were not affected. The NOAEL has to be considered higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have","page":8,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =36 | mg/kg bw/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1","dose":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-...","effect":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-dose group only. The last finding was considered to be within the limits for historical controls. Under the conditions of this study no teratogenic potential was found. The NOAEL for maternal toxicity and embryotoxicity was 3,6 mg/kg bw/day. Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1.1, 3.6 and 35.6 mg/kg bw/day from day 15 of gestation through day 20 of lactation. A slight decrease in foetal viability occurred in all dosed groups and in postnatal survival in the mid- and top-dose group. Those findings may be related to the maternal toxicity. Ref. : 9 An additional oral teratogenicity study has been carried out (1995). Sprague Dawley CD pregnant rats (24/","page":9,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =36 | mg/kg bw/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1","dose":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-...","effect":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-dose group only. The last finding was considered to be within the limits for historical controls. Under the conditions of this study no teratogenic potential was found. The NOAEL for maternal toxicity and embryotoxicity was 3,6 mg/kg bw/day. Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1.1, 3.6 and 35.6 mg/kg bw/day from day 15 of gestation through day 20 of lactation. A slight decrease in foetal viability occurred in all dosed groups and in postnatal survival in the mid- and top-dose group. Those findings may be related to the maternal toxicity. Ref. : 9 An additional oral teratogenicity study has been carried out (1995). Sprague Dawley CD pregnant rats (24/","page":9,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =36 | mg/kg bw/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1","dose":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-...","effect":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-dose group only. The last finding was considered to be within the limits for historical controls. Under the conditions of this study no teratogenic potential was found. The NOAEL for maternal toxicity and embryotoxicity was 3,6 mg/kg bw/day. Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1.1, 3.6 and 35.6 mg/kg bw/day from day 15 of gestation through day 20 of lactation. A slight decrease in foetal viability occurred in all dosed groups and in postnatal survival in the mid- and top-dose group. Those findings may be related to the maternal toxicity. Ref. : 9 An additional oral teratogenicity study has been carried out (1995). Sprague Dawley CD pregnant rats (24/","page":9,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =36 | mg/kg bw/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1","dose":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-...","effect":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-dose group only. The last finding was considered to be within the limits for historical controls. Under the conditions of this study no teratogenic potential was found. The NOAEL for maternal toxicity and embryotoxicity was 3,6 mg/kg bw/day. Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1.1, 3.6 and 35.6 mg/kg bw/day from day 15 of gestation through day 20 of lactation. A slight decrease in foetal viability occurred in all dosed groups and in postnatal survival in the mid- and top-dose group. Those findings may be related to the maternal toxicity. Ref. : 9 An additional oral teratogenicity study has been carried out (1995). Sprague Dawley CD pregnant rats (24/","page":9,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | chronic | NOAEL study | {"citation":"Ref. : 17 2","dose":"At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present.","effect":"the epithelium involving the underlying dermis and subcutaneous tissues. At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present. The no systemic effect level was there at least 12.5 mg/kg bw/day. Ref. : 17 2.3.5. Chronic toxicity In a one year study, groups of 3 dogs were fed 0, 5, 100 or 500 ppm (providing intake levels of 0, 0.4, 8 or 40 mg/kg bw/day) in the diet. No changes were observed in growth rate, haematology or in gross or microscopic pathology. The NOAEL can be considered greater than 40 mg/kg bw. A two-year study has been conducted with groups of 5 rats/sex, fed diets containing 0, 50, 200, 1000, 2500 or 5000 ppm (providing 0, 4, 16, 80, 200 or 400 mg/kg bw/day). The top dose induced mortality. With 2500 and 5000 ppm testicular atrophy and caecal enlargement occurred.","page":6,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adver","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_010"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | chronic | NOAEL study | {"citation":"Ref. : 17 2","dose":"At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present.","effect":"the epithelium involving the underlying dermis and subcutaneous tissues. At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present. The no systemic effect level was there at least 12.5 mg/kg bw/day. Ref. : 17 2.3.5. Chronic toxicity In a one year study, groups of 3 dogs were fed 0, 5, 100 or 500 ppm (providing intake levels of 0, 0.4, 8 or 40 mg/kg bw/day) in the diet. No changes were observed in growth rate, haematology or in gross or microscopic pathology. The NOAEL can be considered greater than 40 mg/kg bw. A two-year study has been conducted with groups of 5 rats/sex, fed diets containing 0, 50, 200, 1000, 2500 or 5000 ppm (providing 0, 4, 16, 80, 200 or 400 mg/kg bw/day). The top dose induced mortality. With 2500 and 5000 ppm testicular atrophy and caecal enlargement occurred.","page":6,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adver","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_010"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | chronic | NOAEL study | {"citation":"Ref. : 17 2","dose":"At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present.","effect":"the epithelium involving the underlying dermis and subcutaneous tissues. At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present. The no systemic effect level was there at least 12.5 mg/kg bw/day. Ref. : 17 2.3.5. Chronic toxicity In a one year study, groups of 3 dogs were fed 0, 5, 100 or 500 ppm (providing intake levels of 0, 0.4, 8 or 40 mg/kg bw/day) in the diet. No changes were observed in growth rate, haematology or in gross or microscopic pathology. The NOAEL can be considered greater than 40 mg/kg bw. A two-year study has been conducted with groups of 5 rats/sex, fed diets containing 0, 50, 200, 1000, 2500 or 5000 ppm (providing 0, 4, 16, 80, 200 or 400 mg/kg bw/day). The top dose induced mortality. With 2500 and 5000 ppm testicular atrophy and caecal enlargement occurred.","page":6,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adver","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_010"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw | rat | oral | chronic | NOAEL study | {"citation":"Ref. : 17 2","dose":"At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present.","effect":"the epithelium involving the underlying dermis and subcutaneous tissues. At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present. The no systemic effect level was there at least 12.5 mg/kg bw/day. Ref. : 17 2.3.5. Chronic toxicity In a one year study, groups of 3 dogs were fed 0, 5, 100 or 500 ppm (providing intake levels of 0, 0.4, 8 or 40 mg/kg bw/day) in the diet. No changes were observed in growth rate, haematology or in gross or microscopic pathology. The NOAEL can be considered greater than 40 mg/kg bw. A two-year study has been conducted with groups of 5 rats/sex, fed diets containing 0, 50, 200, 1000, 2500 or 5000 ppm (providing 0, 4, 16, 80, 200 or 400 mg/kg bw/day). The top dose induced mortality. With 2500 and 5000 ppm testicular atrophy and caecal enlargement occurred.","page":6,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adver","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_010"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw | rat | dermal | 5 days | irritation | {"citation":"Ref. : 31 In humans, 0","dose":"Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement.","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement. The NOAEL can be considered at least 80 mg/kg bw. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Skin irritation in rabbits did not occur when 2 ml of a 0.1 % dilution were applied daily 5 days a week for 4 weeks. Topical application of a 1% (w/v) aqueous solution of benzethonium chloride (100 \u0001l/ 10 cm2) to the dorsal skin of three male and three female rats for 5 days, only produced slight irritation (very slight to well-defined erythema and occasional very slight oedema). Ref. : 31 In humans, 0.1 ml of a 5 % aque","page":7,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, we","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw | rat | dermal | 5 days | irritation | {"citation":"Ref. : 31 In humans, 0","dose":"Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement.","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement. The NOAEL can be considered at least 80 mg/kg bw. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Skin irritation in rabbits did not occur when 2 ml of a 0.1 % dilution were applied daily 5 days a week for 4 weeks. Topical application of a 1% (w/v) aqueous solution of benzethonium chloride (100 \u0001l/ 10 cm2) to the dorsal skin of three male and three female rats for 5 days, only produced slight irritation (very slight to well-defined erythema and occasional very slight oedema). Ref. : 31 In humans, 0.1 ml of a 5 % aque","page":7,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, we","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw | rat | dermal | 5 days | irritation | {"citation":"Ref. : 31 In humans, 0","dose":"Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement.","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement. The NOAEL can be considered at least 80 mg/kg bw. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Skin irritation in rabbits did not occur when 2 ml of a 0.1 % dilution were applied daily 5 days a week for 4 weeks. Topical application of a 1% (w/v) aqueous solution of benzethonium chloride (100 \u0001l/ 10 cm2) to the dorsal skin of three male and three female rats for 5 days, only produced slight irritation (very slight to well-defined erythema and occasional very slight oedema). Ref. : 31 In humans, 0.1 ml of a 5 % aque","page":7,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, we","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw | rat | dermal | 5 days | irritation | {"citation":"Ref. : 31 In humans, 0","dose":"Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement.","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement. The NOAEL can be considered at least 80 mg/kg bw. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Skin irritation in rabbits did not occur when 2 ml of a 0.1 % dilution were applied daily 5 days a week for 4 weeks. Topical application of a 1% (w/v) aqueous solution of benzethonium chloride (100 \u0001l/ 10 cm2) to the dorsal skin of three male and three female rats for 5 days, only produced slight irritation (very slight to well-defined erythema and occasional very slight oedema). Ref. : 31 In humans, 0.1 ml of a 5 % aque","page":7,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | {"dose":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg.","effect":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, we","page":13,"pdf":"out158_en.pdf","row_type":"noael_study","study_id":"out158_en_noael_011"} |
ToxRefDB_ToxRefDB_v3_pod.csv 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =0.15 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 week to 103 week | CHR | study_id=5936; toxval_study_source_id=studyid5936_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-erythema|pathology microscopic-skin-ulcer|pathology microscopic-skin-hyperplasia; dose_level=1; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =1.56 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 week to 13 week | SUB | study_id=5927; toxval_study_source_id=studyid5927_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-inflammation|pathology microscopic-skin-hyperplasia|pathology gross-skin-thickened|pathology microscopic-skin-ulcer|pathology gross-skin-lesion(s) (nos)|pathology microscopic-skin-necrosis|organ weight-kidney-relative to body weight|organ weight-kidney-absolute; dose_level=1; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subchronic_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =6.3 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 day to 16 day | SAC | study_id=5924; toxval_study_source_id=studyid5924_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-hyperplasia|pathology microscopic-skin-inflammation|in life observation-body weight-body weight gain|organ weight-thymus-relative to body weight|organ weight-thymus-absolute|pathology gross-skin-lesion(s) (nos)|pathology gross-skin-thickened|in life observation-body weight-body weight|pathology gross-skin-[other]; dose_level=1; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =12.5 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | dermal | 0 day to 16 day | SAC | study_id=5925; toxval_study_source_id=studyid5925_Adult_F0_M_systemic; toxval_effect_list=pathology microscopic-skin-inflammation|pathology microscopic-skin-hyperplasia|pathology gross-skin-lesion(s) (nos)|in life observation-body weight-body weight gain|organ weight-heart-absolute|in life observation-mortality-mortality; dose_level=2; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =1.5 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 week to 103 week | CHR | study_id=5936; toxval_study_source_id=studyid5936_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-ulcer|pathology microscopic-skin-hyperplasia; dose_level=3; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =3.13 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 week to 13 week | SUB | study_id=5927; toxval_study_source_id=studyid5927_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-inflammation|pathology gross-skin-thickened|pathology microscopic-skin-ulcer|pathology microscopic-skin-hyperplasia; dose_level=2; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subchronic_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =25 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 day to 16 day | SAC | study_id=5924; toxval_study_source_id=studyid5924_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-hyperplasia|pathology microscopic-skin-inflammation; dose_level=3; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =50 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | dermal | 0 day to 16 day | SAC | study_id=5925; toxval_study_source_id=studyid5925_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-inflammation|pathology microscopic-skin-hyperplasia; dose_level=4; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | >0 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 day to 16 day | SAC | study_id=5924; toxval_study_source_id=studyid5924_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology gross-skin-[other]|pathology microscopic-skin-hyperplasia|pathology gross-skin-thickened|organ weight-thymus-absolute|pathology gross-skin-lesion(s) (nos)|pathology microscopic-skin-inflammation|in life observation-body weight-body weight gain|organ weight-thymus-relative to body weight; dose_level=0; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =0.5 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 week to 103 week | CHR | study_id=5936; toxval_study_source_id=studyid5936_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-skin-ulcer|in life observation-clinical signs-erythema|pathology microscopic-skin-hyperplasia; dose_level=2; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =12.5 | mg/kg bw/day | rat (fischer; Fischer 344) | dermal | 0 day to 16 day | SAC | study_id=5924; toxval_study_source_id=studyid5924_Adult_F0_F_systemic; toxval_effect_list=organ weight-thymus-relative to body weight|in life observation-body weight-body weight gain|pathology microscopic-skin-inflammation|pathology gross-skin-lesion(s) (nos)|organ weight-thymus-absolute|pathology gross-skin-thickened|pathology microscopic-skin-hyperplasia|pathology gross-skin-[other]|in life observation-body weight-body weight; dose_level=2; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =25 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | dermal | 0 day to 16 day | SAC | study_id=5925; toxval_study_source_id=studyid5925_Adult_F0_F_systemic; toxval_effect_list=organ weight-thymus-absolute|pathology microscopic-skin-inflammation|organ weight-heart-absolute|pathology microscopic-skin-hyperplasia|pathology gross-skin-lesion(s) (nos)|organ weight-heart-relative to body weight|organ weight-thymus-relative to body weight; dose_level=3; study_year=1995; study_citation=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; dsstox_substance_id=DTXSID6023810; admin_method=Topical; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
ToxValDB_ECOTOX 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =15 | mg/kg bw/day | European Rabbit | injection | acute; 0.25 days | acute | LONG_REF=Can. J. Biochem. Physiol.38:25-32 Beck,I.T., E. Pinter, R.D. McKenna, and H. Griff The Selective Proteolytic Enzyme Inhibitory Action of Benzethonium Chloride 1960; TITLE=The Selective Proteolytic Enzyme Inhibitory Action of Benzethonium Chloride; AUTHOR=Beck,I.T., E. Pinter, R.D. McKenna, and H. Griff; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=81244; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1960; ORIGINAL_YEAR=1960; TOXICOLOGICAL_EFFECT=Enzyme(s): Proteolytic activity; TOXICOLOGICAL_EFFECT_CATEGORY=enzyme activity; STUDY_GROUP=ECOTOX:15608663:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=6548f2d7fc3495e93132d90c020d7ab6 |
| ToxValDB_ECOTOX | NOEL | =0.02 | % | European Rabbit | dermal | short-term; 2.25 days | short-term | LONG_REF=J. Toxicol. Cutan. Ocul. Toxicol.8(3): 253-269 Green,K., R.E. Johnson, J.M. Chapman, E. Nelson, and L. Cheeks Surfactant Effects on the Rate of Rabbit Corneal Epithelial Healing 1989; TITLE=Surfactant Effects on the Rate of Rabbit Corneal Epithelial Healing; AUTHOR=Green,K., R.E. Johnson, J.M. Chapman, E. Nelson, and L. Cheeks; DOI=10.3109/15569528909062930; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=81107; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Immunological: Healing; STUDY_GROUP=ECOTOX:15598126:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=3bf35f80c8b5a17e3e8685a9ed47b82a |
| ToxValDB_ECOTOX | NOEL | =0.06 | mg/day | Mouse | dermal | chronic; 140 days | chronic | LONG_REF=Toxicol. Sci.49(2): 241-254 Spalding,J.W., J.E. French, R.R. Tice, M. Furedi-Machacek, J.K. Haseman, and R.W. Tennant Development of a Transgenic Mouse Model for Carcinogenesis Bioassays: Evaluation of Chemically Induced Skin Tumors in Tg.AC Mice 1999; TITLE=Development of a Transgenic Mouse Model for Carcinogenesis Bioassays: Evaluation of Chemically Induced Skin Tumors in Tg.AC Mice; AUTHOR=Spalding,J.W., J.E. French, R.R. Tice, M. Furedi-Machacek, J.K. Haseman, and R.W. Tennant; DOI=10.1093/toxsci/49.2.241; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=81173; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1999; ORIGINAL_YEAR=1999; TOXICOLOGICAL_EFFECT=Injury: Tumor induction; TOXICOLOGICAL_EFFECT_CATEGORY=cancer; STUDY_GROUP=ECOTOX:15604692:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=044aff2fb9c381d1608675680d151159 |
ToxValDB_ToxRefDB 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ToxRefDB | LEL | =0.15 | mg/kg bw/day | Rat | dermal | chronic; 103 weeks | chronic | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5936; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-erythema|systemic: pathology microscopic-skin-hyperplasia|systemic: pathology microscopic-skin-ulcer; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710224_15710225_15710226:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b92b9489ab0a0e7678a01b9deda9a821 |
| ToxValDB_ToxRefDB | LEL | =1.56 | mg/kg bw/day | Rat | dermal | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subchronic_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subchronic_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5927; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-inflammation|systemic: pathology microscopic-skin-hyperplasia|systemic: pathology gross-skin-thickened|systemic: pathology microscopic-skin-ulcer|systemic: pathology gross-skin-lesion(s) (nos)|systemic: pathology microscopic-skin-necrosis|systemic: organ weight-kidney-relative to body weight|systemic: organ weight-kidney-absolute; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710214_15710215_15710216:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a10f347c299fad6cffb3d11e74c66a67 |
| ToxValDB_ToxRefDB | LEL | =6.3 | mg/kg bw/day | Rat | dermal | short-term; 16 days | short-term | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5924; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-hyperplasia|systemic: pathology microscopic-skin-inflammation|systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain|systemic: organ weight-thymus-absolute|systemic: pathology gross-skin-[other]|systemic: pathology gross-skin-thickened|systemic: pathology gross-skin-lesion(s) (nos)|systemic: organ weight-thymus-relative to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710201_15710202_15710203:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_905bf660e3b2820a2a882ac68958cb6d |
| ToxValDB_ToxRefDB | LEL | =12.5 | mg/kg bw/day | Mouse | dermal | short-term; 16 days | short-term | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5925; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-inflammation|systemic: pathology microscopic-skin-hyperplasia|systemic: in life observation-body weight-body weight gain|systemic: pathology gross-skin-lesion(s) (nos)|systemic: in life observation-mortality-mortality|systemic: organ weight-heart-absolute; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710210_15710211_15710212_15710213:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6ff8c2f2d592cd4322d15d7437dada47 |
| ToxValDB_ToxRefDB | LOAEL | =1.5 | mg/kg bw/day | Rat | dermal | chronic; 103 weeks | chronic | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5936; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-hyperplasia|systemic: pathology microscopic-skin-ulcer; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710224_15710225_15710226:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_72fe90e654705510af7afe4fb60825f4 |
| ToxValDB_ToxRefDB | LOAEL | =3.13 | mg/kg bw/day | Rat | dermal | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subchronic_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subchronic_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5927; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-inflammation|systemic: pathology microscopic-skin-hyperplasia|systemic: pathology gross-skin-thickened|systemic: pathology microscopic-skin-ulcer; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710214_15710215_15710216:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3d071236cd30a20ab8139cdd37b9fc9a |
| ToxValDB_ToxRefDB | LOAEL | =25 | mg/kg bw/day | Rat | dermal | short-term; 16 days | short-term | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5924; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-hyperplasia|systemic: pathology microscopic-skin-inflammation; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710201_15710202_15710203:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ffae1f713c1aac864a877ca87f2f1dd2 |
| ToxValDB_ToxRefDB | LOAEL | =50 | mg/kg bw/day | Mouse | dermal | short-term; 16 days | short-term | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5925; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-inflammation|systemic: pathology microscopic-skin-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710207_15710208_15710209:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a858aeaeb98b51225119d16c0415ed23 |
| ToxValDB_ToxRefDB | NOAEL | =0.5 | mg/kg bw/day | Rat | dermal | chronic; 103 weeks | chronic | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Chronic_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5936; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-hyperplasia|systemic: pathology microscopic-skin-ulcer|systemic: in life observation-clinical signs-erythema; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710224_15710225_15710226:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5aa7a2701fe9c48aa9c969884a4d2fc5 |
| ToxValDB_ToxRefDB | NOAEL | =12.5 | mg/kg bw/day | Rat | dermal | short-term; 16 days | short-term | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5924; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-skin-hyperplasia|systemic: organ weight-thymus-relative to body weight|systemic: pathology gross-skin-lesion(s) (nos)|systemic: pathology gross-skin-thickened|systemic: pathology gross-skin-[other]|systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain|systemic: organ weight-thymus-absolute|systemic: pathology microscopic-skin-inflammation; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710201_15710202_15710203:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_84eabae9ba832a5fc66c57e8b0b58fe6 |
| ToxValDB_ToxRefDB | NOAEL | =25 | mg/kg bw/day | Mouse | dermal | short-term; 16 days | short-term | LONG_REF=NTP_1995_TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; TITLE=TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS\nSTUDIES OF BENZETHONIUM CHLORIDE (CAS NO. 121-54-0) IN F344/N RATS AND B6C3Fl MICE (DERMAL STUDIES)_Subacute_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5925; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=systemic: pathology gross-skin-lesion(s) (nos)|systemic: organ weight-heart-relative to body weight|systemic: organ weight-thymus-relative to body weight|systemic: organ weight-thymus-absolute|systemic: pathology microscopic-skin-inflammation|systemic: organ weight-heart-absolute|systemic: pathology microscopic-skin-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15710207_15710208_15710209:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_47e5a1f504dcf41cedb435ff499a13b2 |
UnifiedCodex:SCCNFP:beta.noael_studies 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 0.014 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=0.014; DOSE=Systemic exposure (SED) | 17790 x 0.001 x 0.0472/60 | = | 0.014 mg/kg bw/day; EFFECT=Visible table on page 10: Systemic exposure (SED) | 17790 x 0.001 x 0.0472/60 | = | 0.014 mg/kg bw/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"Systemic exposure (SED) | 17790 x 0.001 x 0.0472/60 | = | 0.014 mg/kg bw/day","duration":"","effect":"Visible table on page 10: Systemic exposure (SED) | 17790 x 0.001 x 0.0472/60 | = | 0.014 mg/kg bw/day","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"0.014","page":10,"route":"","species":"","study_id":"out250_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 3.6 | mg/kg bw/day | rat | oral | - | - | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=3.6; DOSE=the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day.; EFFECT=the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for maternal toxicity and embryo-toxicity in this study was 3.6 mg/kg bw/day. Ref. : 8 - In a teratogenicity study in Long Evans (20 per Group) rats with oral dosing of 1.1, 3.6 or 35.6 mg/kg bw/day on gestational days 6 to 15 the high-dose group showed decreased maternal body weight and an increased number of smaller pups. An increased incidence of skeletal variants (ossification effects) occurred in all treated groups. Skeletal malformation was increased in the high-dose group. Slight hydrocephalus was seen in o; CITATION=Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1; CITATION_NUMBERS=[3,15,27,1]; REFERENCE=Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1","dose":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day.","duration":"","effect":"the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for maternal toxicity and embryo-toxicity in this study was 3.6 mg/kg bw/day. Ref. : 8 - In a teratogenicity study in Long Evans (20 per Group) rats with oral dosing of 1.1, 3.6 or 35.6 mg/kg bw/day on gestational days 6 to 15 the high-dose group showed decreased maternal body weight and an increased number of smaller pups. An increased incidence of skeletal variants (ossification effects) occurred in all treated groups. Skeletal malformation was increased in the high-dose group. Slight hydrocephalus was seen in o","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3.6","page":8,"route":"oral","species":"rat","study_id":"out158_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 3.6 | mg/kg BW/day | - | - | - | - | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=3.6; DOSE=3.6 mg/kg BW/day MOS :; EFFECT=SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 15 NOAEL : 3.6 mg/kg BW/day MOS : 40 For use in all types of leave-on cosmetics, the above Margin of Safety is considered unacceptable. 2.12. Opinion The data provided in the submitted dossier does not support the requested use of Benzethonium chloride as a preservative in leave-on products. Its present use as a preservative in rinse-off products at a maximum authorised concentration of 0.1 % is considered safe. 2.13. References 1. De Flora S., Study of 106 organic and inorganic compounds in the Salmonella/microsome test.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"3.6 mg/kg BW/day MOS :","duration":"","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 15 NOAEL : 3.6 mg/kg BW/day MOS : 40 For use in all types of leave-on cosmetics, the above Margin of Safety is considered unacceptable. 2.12. Opinion The data provided in the submitted dossier does not support the requested use of Benzethonium chloride as a preservative in leave-on products. Its present use as a preservative in rinse-off products at a maximum authorised concentration of 0.1 % is considered safe. 2.13. References 1. De Flora S., Study of 106 organic and inorganic compounds in the Salmonella/microsome test.","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg BW/day","noael_value":"3.6","page":15,"route":"","species":"","study_id":"out158_en_noael_014"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 3.6 | mg/kg BW/day | - | - | - | - | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=3.6; DOSE=NOAEL | 3.6 mg/kg BW/day; EFFECT=Visible table on page 15: NOAEL | 3.6 mg/kg BW/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"NOAEL | 3.6 mg/kg BW/day","duration":"","effect":"Visible table on page 15: NOAEL | 3.6 mg/kg BW/day","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg BW/day","noael_value":"3.6","page":15,"route":"","species":"","study_id":"out158_en_noael_015"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 3.6 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=3.6; DOSE=NOAEL | = | 3.6 mg/kg bw/day; EFFECT=Visible table on page 10: NOAEL | = | 3.6 mg/kg bw/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"NOAEL | = | 3.6 mg/kg bw/day","duration":"","effect":"Visible table on page 10: NOAEL | = | 3.6 mg/kg bw/day","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3.6","page":10,"route":"","species":"","study_id":"out250_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 40 | mg/kg bw | rat | oral | chronic | - | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=40; DOSE=At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present.; EFFECT=the epithelium involving the underlying dermis and subcutaneous tissues. At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present. The no systemic effect level was there at least 12.5 mg/kg bw/day. Ref. : 17 2.3.5. Chronic toxicity In a one year study, groups of 3 dogs were fed 0, 5, 100 or 500 ppm (providing intake levels of 0, 0.4, 8 or 40 mg/kg bw/day) in the diet. No changes were observed in growth rate, haematology or in gross or microscopic pathology. The NOAEL can be considered greater than 40 mg/kg bw. A two-year study has been conducted with groups of 5 rats/sex, fed diets containing 0, 50, 200, 1000, 2500 or 5000 ppm (providing 0, 4, 16, 80, 200 or 400 mg/kg bw/day). The top dose induced mortality. With 2500 and 5000 ppm testicular atrophy and caecal enlargement occurred.; CITATION=Ref. : 17 2; CITATION_NUMBERS=[17,2]; REFERENCE=Ref. : 17 2; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 17 2","dose":"At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present.","duration":"chronic","effect":"the epithelium involving the underlying dermis and subcutaneous tissues. At 1.56 or 3.13 mg/kg bw/day minimal epithelial hyperplasia with or without chronic inflammation were present. The no systemic effect level was there at least 12.5 mg/kg bw/day. Ref. : 17 2.3.5. Chronic toxicity In a one year study, groups of 3 dogs were fed 0, 5, 100 or 500 ppm (providing intake levels of 0, 0.4, 8 or 40 mg/kg bw/day) in the diet. No changes were observed in growth rate, haematology or in gross or microscopic pathology. The NOAEL can be considered greater than 40 mg/kg bw. A two-year study has been conducted with groups of 5 rats/sex, fed diets containing 0, 50, 200, 1000, 2500 or 5000 ppm (providing 0, 4, 16, 80, 200 or 400 mg/kg bw/day). The top dose induced mortality. With 2500 and 5000 ppm testicular atrophy and caecal enlargement occurred.","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":6,"route":"oral","species":"rat","study_id":"out158_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =0.014 | mg/kg bw/day | rat | - | - | dermal absorption | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT== 0.014; DOSE=SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...; EFFECT=SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. I; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...","duration":"","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. I","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 0.014","page":10,"route":"","species":"rat","study_id":"out250_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =3.6 | mg/kg bw/day | rat | - | - | dermal absorption | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT== 3.6; DOSE=SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...; EFFECT=SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. Inveresk Research, Tranent EH33 2NE Scotland. Project 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Sa...","duration":"","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 10 Typical body weight = 60 kg Cumulative exposure to preservatives = 17790 mg/day Systemic exposure (SED) 17790 x 0.001 x 0.0472/60 = 0.014 mg/kg bw/day NOAEL = 3.6 mg/kg bw/day Margin of Safety NOEL / SED = 257 2.12 Conclusions For use in all types of leave-on cosmetics, the above Margin of Safety is considered acceptable. 2.13 References 32. Wilson D.M., White R.D., Gonder J., Preliminary pharmacokinetics study of dermally applied 14C-Benzethonium Chloride in rats. Baxter Lab. Report, Study 10936, 4.10.02 36. Roper C.S. The In vitro Percutaneous Absorption of [14C]-Benzethonium Chloride Through Human Skin as a 1.0% (w/v) solution in Ethanol. Inveresk Research, Tranent EH33 2NE Scotland. Project 20","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 3.6","page":10,"route":"","species":"rat","study_id":"out250_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 36 | mg/kg bw/day | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=3,6; DOSE=s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-...; EFFECT=s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-dose group only. The last finding was considered to be within the limits for historical controls. Under the conditions of this study no teratogenic potential was found. The NOAEL for maternal toxicity and embryotoxicity was 3,6 mg/kg bw/day. Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1.1, 3.6 and 35.6 mg/kg bw/day from day 15 of gestation through day 20 of lactation. A slight decrease in foetal viability occurred in all dosed groups and in postnatal survival in the mid- and top-dose group. Those findings may be related to the maternal toxicity. Ref. : 9 An additional oral teratogenicity study has been carried out (1995). Sprague Dawley CD pregnant rats (24/; CITATION=Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1; CITATION_NUMBERS=[7,1]; REFERENCE=Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1","dose":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-...","duration":"","effect":"s been renewed by the same workers in Long Evans rats (18 to 20/group) with oral dosing of 0, 0.06, 1.1, 3.6 or 35.6 mg/kg bw/day, on gestational days 6 to 15; this second teratogenicity study showed lower maternal body weights, increased variation of skeletal ossification and increased incidence of skeletal malformations (wavy ribs) in the top-dose group only. The last finding was considered to be within the limits for historical controls. Under the conditions of this study no teratogenic potential was found. The NOAEL for maternal toxicity and embryotoxicity was 3,6 mg/kg bw/day. Ref. : 7 Peri-and postnatal effects were examined in rats dosed orally with 1.1, 3.6 and 35.6 mg/kg bw/day from day 15 of gestation through day 20 of lactation. A slight decrease in foetal viability occurred in all dosed groups and in postnatal survival in the mid- and top-dose group. Those findings may be related to the maternal toxicity. Ref. : 9 An additional oral teratogenicity study has been carried out (1995). Sprague Dawley CD pregnant rats (24/","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3,6","page":9,"route":"oral","species":"rat","study_id":"out158_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 0.1 | % | rat | oral | 28 day | irritation | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=0.1; DOSE=In one study in rats, a dose-related increase in the incidence of granulomatous reactions (mainly fibrosarcomas) occurred at the injection site.; EFFECT=2.10. Special investigations Several subcutaneous injection studies have been reported in rats and mice. In one study in rats, a dose-related increase in the incidence of granulomatous reactions (mainly fibrosarcomas) occurred at the injection site. Concentrations as low as 0.002 % inhibited the motility of the isolated ileum of rats and rabbits. Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/k; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"In one study in rats, a dose-related increase in the incidence of granulomatous reactions (mainly fibrosarcomas) occurred at the injection site.","duration":"28 day","effect":"2.10. Special investigations Several subcutaneous injection studies have been reported in rats and mice. In one study in rats, a dose-related increase in the incidence of granulomatous reactions (mainly fibrosarcomas) occurred at the injection site. Concentrations as low as 0.002 % inhibited the motility of the isolated ileum of rats and rabbits. Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/k","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"0.1","page":13,"route":"oral","species":"rat","study_id":"out158_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 0.1 | % | rat | oral | 28 day | irritation | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=0.1; DOSE=The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.; EFFECT=SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 8 2.11. Safety evaluation Determination of the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.","duration":"28 day","effect":"SCCNFP/0762/03 Evaluation and opinion on Benzethonium Chloride ____________________________________________________________________________________________ 8 2.11. Safety evaluation Determination of the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"0.1","page":8,"route":"oral","species":"rat","study_id":"out250_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 80 | mg/kg bw | rat | dermal | 5 days | irritation | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=80; DOSE=Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement.; EFFECT=SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement. The NOAEL can be considered at least 80 mg/kg bw. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Skin irritation in rabbits did not occur when 2 ml of a 0.1 % dilution were applied daily 5 days a week for 4 weeks. Topical application of a 1% (w/v) aqueous solution of benzethonium chloride (100 l/ 10 cm2) to the dorsal skin of three male and three female rats for 5 days, only produced slight irritation (very slight to well-defined erythema and occasional very slight oedema). Ref. : 31 In humans, 0.1 ml of a 5 % aque; CITATION=Ref. : 31 In humans, 0; CITATION_NUMBERS=[31]; REFERENCE=Ref. : 31 In humans, 0; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 31 In humans, 0","dose":"Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement.","duration":"5 days","effect":"SCCNFP/0539/01 Evaluation and opinion on : Benzethonium Chloride ____________________________________________________________________________________________ 7 With 1000 ppm there was only caecal enlargement. The NOAEL can be considered at least 80 mg/kg bw. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Skin irritation in rabbits did not occur when 2 ml of a 0.1 % dilution were applied daily 5 days a week for 4 weeks. Topical application of a 1% (w/v) aqueous solution of benzethonium chloride (100 \u0001l/ 10 cm2) to the dorsal skin of three male and three female rats for 5 days, only produced slight irritation (very slight to well-defined erythema and occasional very slight oedema). Ref. : 31 In humans, 0.1 ml of a 5 % aque","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"80","page":7,"route":"dermal","species":"rat","study_id":"out158_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 0.1 | % | rat | dermal | 28-day | repeated dose toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=0.1; DOSE=The results confirmed most of the changes seen at the top dose, including caecal enlargement.; EFFECT=___________________________________________________ 5 - A supplementary 28-day study in rats with the same feeding levels was conducted to verify and extend certain findings in the previous study. The results confirmed most of the changes seen at the top dose, including caecal enlargement. The latter finding was not accompanied by histopathological changes. Decreased levels of serum-P seen at the two higher levels in the previous study did not occur in the present study. Therefore, 500 ppm (or 40 mg/kg bw) was the NOAEL in the supplementary study. Ref. : 15 2.3.3. Repeated dose dermal toxicity Subacute study In a dermal application of 2 ml 0.1 % solution to the skin of rabbits daily, 5 days/week for 4 weeks no systemic effects were observed (Summary Report). In a 16-day study, F 344/N rats (5 males + 5 females/group) received topical applications of a fixed 250 ml volume of ethanol solutions corresponding to 0, 6.3, 12.5, 25, 50 or 100 mg benzethonium chloride/kg bw/day. Animals were treated 5 days per week for a total of 12 dose; CITATION=Ref. : 15 2; CITATION_NUMBERS=[15,2]; REFERENCE=Ref. : 15 2; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 15 2","dose":"The results confirmed most of the changes seen at the top dose, including caecal enlargement.","duration":"28-day","effect":"___________________________________________________ 5 - A supplementary 28-day study in rats with the same feeding levels was conducted to verify and extend certain findings in the previous study. The results confirmed most of the changes seen at the top dose, including caecal enlargement. The latter finding was not accompanied by histopathological changes. Decreased levels of serum-P seen at the two higher levels in the previous study did not occur in the present study. Therefore, 500 ppm (or 40 mg/kg bw) was the NOAEL in the supplementary study. Ref. : 15 2.3.3. Repeated dose dermal toxicity Subacute study In a dermal application of 2 ml 0.1 % solution to the skin of rabbits daily, 5 days/week for 4 weeks no systemic effects were observed (Summary Report). In a 16-day study, F 344/N rats (5 males + 5 females/group) received topical applications of a fixed 250 ml volume of ethanol solutions corresponding to 0, 6.3, 12.5, 25, 50 or 100 mg benzethonium chloride/kg bw/day. Animals were treated 5 days per week for a total of 12 dose","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"0.1","page":5,"route":"dermal","species":"rat","study_id":"out158_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 3.6 | mg/kg bw/day | rat | oral | - | repeated dose toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=3.6; DOSE=Calculated safety margin According to the all given data, the NOAEL in oral repeated dose studies may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies.; EFFECT=system in an in vivo assay. - In a recent in vitro study with human and rat dermatomed skin membranes, the max penetration of 10 l/cm2 of a 1% formulation of benzethonium chloride through human skin was 0.29% (0.29 g benzethonium chloride/cm2/24h) and the total amount absorbed was 4.14% (4.14 g benzethonium chloride/cm2/24h). Competition may exist between the local reaction induced on skin by benzethonium chloride and its absorption through the skin. Calculated safety margin According to the all given data, the NOAEL in oral repeated dose studies may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies. Based on the data from a recently conducted in vitro skin penetration study the following calculations can be made. Percutaneous absorption : 0.29 g Benzethonium Chloride/cm2/day Typical body weight : 60 kg Skin area surface : 18000 cm2 Systemic exposure : 18000 cm2 x 0.29 g /cm2 = 0.09 mg/kg bw/day 60 kg x 1000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"Calculated safety margin According to the all given data, the NOAEL in oral repeated dose studies may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies.","duration":"","effect":"system in an in vivo assay. - In a recent in vitro study with human and rat dermatomed skin membranes, the max penetration of 10 \u0001l/cm2 of a 1% formulation of benzethonium chloride through human skin was 0.29% (0.29 \u0001g benzethonium chloride/cm2/24h) and the total amount absorbed was 4.14% (4.14 \u0001g benzethonium chloride/cm2/24h). Competition may exist between the local reaction induced on skin by benzethonium chloride and its absorption through the skin. Calculated safety margin According to the all given data, the NOAEL in oral repeated dose studies may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies. Based on the data from a recently conducted in vitro skin penetration study the following calculations can be made. Percutaneous absorption : 0.29 \u0001g Benzethonium Chloride/cm2/day Typical body weight : 60 kg Skin area surface : 18000 cm2 Systemic exposure : 18000 cm2 x 0.29 \u0001g /cm2 = 0.09 mg/kg bw/day 60 kg x 1000","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3.6","page":14,"route":"oral","species":"rat","study_id":"out158_en_noael_013"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 3.6 | mg/kg bw/day | rat | oral | - | repeated dose toxicity | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=3.6; DOSE=Calculation of the Margin of safety According to data present in the first submission, the NOAEL in oral repeated dose studies in rats may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies.; EFFECT=nium Chloride. Since only 5 tape strippings have been done for the measurement of the amount of test compound in the stratum corneum, it is very likely that the value measured for the epidermis, will constitute an overestimation of the actual amount. Therefore, it is acceptable to perform the calculation of the Margin of Safety with the obtained value of 4.72% dermal absorption (dermis-value is included in this figure). Calculation of the Margin of safety According to data present in the first submission, the NOAEL in oral repeated dose studies in rats may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies. Based on the data from the recently conducted in vitro skin penetration studies, the following calculations can be made. Percutaneous absorption = 4.72% Intended concentration in finished product = 0.1%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"Calculation of the Margin of safety According to data present in the first submission, the NOAEL in oral repeated dose studies in rats may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies.","duration":"","effect":"nium Chloride. Since only 5 tape strippings have been done for the measurement of the amount of test compound in the stratum corneum, it is very likely that the value measured for the epidermis, will constitute an overestimation of the actual amount. Therefore, it is acceptable to perform the calculation of the Margin of Safety with the obtained value of 4.72% dermal absorption (dermis-value is included in this figure). Calculation of the Margin of safety According to data present in the first submission, the NOAEL in oral repeated dose studies in rats may be considered as being 3.6 mg/kg bw/day which corresponds to the lowest oral dose presenting no adverse effect from all acceptable given studies. Based on the data from the recently conducted in vitro skin penetration studies, the following calculations can be made. Percutaneous absorption = 4.72% Intended concentration in finished product = 0.1%","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3.6","page":9,"route":"oral","species":"rat","study_id":"out250_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 8 | mg/kg bw/day | rat | oral | Subacute | repeated dose toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=8; DOSE=at, LD50 = 19 mg/kg 2.3.2.; EFFECT=at, LD50 = 19 mg/kg 2.3.2. Repeated dose oral toxicity Subacute study - In a 28-day feeding study, rats received diets with 0, 20, 100, 500 or 2500 ppm, providing intake levels of 0, 1.7, 8, 40 or 200 mg/kg bw/day. The changes in the top-dose group included growth retardation, caecum enlargement, signs of liver damage and decreased serum levels of inorganic phosphorus in males. The last finding was the only effect considered treatment-related in males fed 500 ppm. The diet with 100 ppm (8 mg/kg bw/day) was a clear NOAEL. Ref. : 14; CITATION=Ref. : 14; CITATION_NUMBERS=[14]; REFERENCE=Ref. : 14; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 14","dose":"at, LD50 = 19 mg/kg 2.3.2.","duration":"Subacute","effect":"at, LD50 = 19 mg/kg 2.3.2. Repeated dose oral toxicity Subacute study - In a 28-day feeding study, rats received diets with 0, 20, 100, 500 or 2500 ppm, providing intake levels of 0, 1.7, 8, 40 or 200 mg/kg bw/day. The changes in the top-dose group included growth retardation, caecum enlargement, signs of liver damage and decreased serum levels of inorganic phosphorus in males. The last finding was the only effect considered treatment-related in males fed 500 ppm. The diet with 100 ppm (8 mg/kg bw/day) was a clear NOAEL. Ref. : 14","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"8","page":4,"route":"oral","species":"rat","study_id":"out158_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=40; DOSE=Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg.; EFFECT=Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adver; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg.","duration":"28 day","effect":"Blood pressure measurements in the dog indicated nearly complete blockage of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adver","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":13,"route":"oral","species":"rat","study_id":"out158_en_noael_010"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=40; DOSE=The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.; EFFECT=tion of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, were noted. The non systemic observable effects were then respectively 50 mg/kg bw/day f; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.","duration":"28 day","effect":"tion of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, were noted. The non systemic observable effects were then respectively 50 mg/kg bw/day f","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":13,"route":"oral","species":"rat","study_id":"out158_en_noael_012"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=40; DOSE=The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.; EFFECT=enzethonium Chloride ____________________________________________________________________________________________ 8 2.11. Safety evaluation Determination of the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium Chloride was administered dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some advers; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.","duration":"28 day","effect":"enzethonium Chloride ____________________________________________________________________________________________ 8 2.11. Safety evaluation Determination of the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium Chloride was administered dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some advers","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":8,"route":"oral","species":"rat","study_id":"out250_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 40 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=40; DOSE=The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.; EFFECT=the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium Chloride was administered dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, were noted. The non systemic observable effects were then respectively 50 mg/kg bw/day fo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.","duration":"28 day","effect":"the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium Chloride was administered dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, were noted. The non systemic observable effects were then respectively 50 mg/kg bw/day fo","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":8,"route":"oral","species":"rat","study_id":"out250_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 80 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=80; DOSE=e of sympathetic ganglia at an i.v. dose of 2 mg/kg.; EFFECT=e of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, we; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg.","duration":"28 day","effect":"e of sympathetic ganglia at an i.v. dose of 2 mg/kg. 2.11. Safety evaluation Determination of the NOAEL In summary, benzethonium chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium chloride was administrated dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, we","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":13,"route":"oral","species":"rat","study_id":"out158_en_noael_011"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 80 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | SOURCE_SUBDIR=out250_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE COLIPA n° P 70; OPINION_NUMBER=SCCNFP/0762/03; COMMITTEE=SCCNFP; REPORT_DATE=9 December 2003; VALUE_TEXT=80; DOSE=The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.; EFFECT=________________________________________ 8 2.11. Safety evaluation Determination of the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum "in use" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium Chloride was administered dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, wer; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"121-54-0","citation":"","dose":"The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day.","duration":"28 day","effect":"________________________________________ 8 2.11. Safety evaluation Determination of the NOAEL [SCCNFP/0539/01] Benzethonium Chloride has moderate acute toxicity by the oral route and high toxicity following parenteral exposure. It produced very slight irritation at the maximum \"in use\" concentration (0.1 %) and significant irritation when applied at a concentration of 5 %. It was not sensitiser to guinea pig or human skin. The acceptable NOAEL in a 28 day repeated oral studies in rats was 40 mg/kg bw/day. The NOAEL in the same animal species was at least 80 mg/kg bw/day in a 2 years study. The NOAEL was 40 mg/kg bw/day in a one year toxicity study on dogs. Benzethonium Chloride was administered dermally to rats and mice in subacute (16 days), subchronic (13 weeks) and carcinogenicity studies (2 years). In all studies, the maximum applied dose was limited by local skin effects of various degrees of severity. In spite of those local reactions, some adverse effects, for which a relation to the treatments cannot be excluded, wer","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":8,"route":"oral","species":"rat","study_id":"out250_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | 1 | mg/kg bw/day | rabbit | oral | - | reproductive toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1; DOSE=ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance.; EFFECT=ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have been observed; the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for; CITATION=Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m; CITATION_NUMBERS=[5,15,1,3,10,7,19]; REFERENCE=Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 m","dose":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance.","duration":"","effect":"ed higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have been observed; the NOAEL for maternal toxicity and embryotoxicity was 1 mg/kg bw/day. Ref. : 3 In a second teratogenicity study in New Zealand white rabbits (15 to 27/group) with oral dosing of 1.1, 3.6 and 35.6 mg/kg bw/day, on gestational days 7 to 19, the high dose induced maternal and foetal mortality. A dose-related increase in foetal resorptions occurred in all treatment groups although the change was statistically significant only in the high-dose group. No substance related malformations were found at any dose level. The NOAEL for","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1","page":8,"route":"oral","species":"rabbit","study_id":"out158_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | 35.6 | mg/kg bw/day | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=out158_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZETHONIUM CHLORIDE Colipa n° P70; OPINION_NUMBER=SCCNFP/0539/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=35.6; DOSE=administered at 0.3% did not elicit dermal irritation and/or sensitisation.; EFFECT=administered at 0.3% did not elicit dermal irritation and/or sensitisation. Ref. : 35 2.6. Teratogenicity Fertility and reproductive performance were examined in rats treated orally with 1.1, 3.6 and 35.6 mg/kg bw/day prior to and during mating and during the gestation and lactation period. The high- dose produced growth depression, increased irritability, respiratory signs in the parents and decreased viability and body weight of pups at birth. Fertility and general reproductive performance were not affected. The NOAEL has to be considered higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have; CITATION=Ref. : 35 2; CITATION_NUMBERS=[35,2]; REFERENCE=Ref. : 35 2; DETAILS_JSON={"cas_number":"121-54-0","citation":"Ref. : 35 2","dose":"administered at 0.3% did not elicit dermal irritation and/or sensitisation.","duration":"","effect":"administered at 0.3% did not elicit dermal irritation and/or sensitisation. Ref. : 35 2.6. Teratogenicity Fertility and reproductive performance were examined in rats treated orally with 1.1, 3.6 and 35.6 mg/kg bw/day prior to and during mating and during the gestation and lactation period. The high- dose produced growth depression, increased irritability, respiratory signs in the parents and decreased viability and body weight of pups at birth. Fertility and general reproductive performance were not affected. The NOAEL has to be considered higher than 35.6 mg/kg bw/day for the fertility and reproductive performance. Ref. : 5 An oral teratogenicity study in New Zealand white rabbits (15/group) with 1, 3 and 10 mg/kg bw/day on gestational days 7 to 19 revealed signs of maternal toxicity with 3 and 10 mg, increased mortality of mothers and pups with 10 mg, and an increased incidence of supernumerary ribs with 3 and 10 mg. Supernumerary ribs are known to occur secondary to maternal toxicity (Khera 1985). No teratogenic effects have","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"35.6","page":8,"route":"oral","species":"rat","study_id":"out158_en_noael_005"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | PH41D05744 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H42NO2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PH41D05744"} |
| openFDA substances | FDA UNII substance identifier | PH41D05744 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H42NO2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PH41D05744"} |
| openFDA substances | FDA UNII substance identifier | PH41D05744 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H42NO2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PH41D05744"} |
| openFDA substances | FDA UNII substance identifier | PH41D05744 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H42NO2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PH41D05744"} |