NOAEL Studies Surfactant

Cetrimonium Chloride NOAEL Studies

INCI: CETRIMONIUM CHLORIDE

CAS: 112-02-7

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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NTP ICE acute oral 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 =450 mg/kg bw Rat oral acute Rat Acute Oral Toxicity OECD eChemPortal (undated); record_id=acute_oral_1152; row=10440; data_type=In Vivo; mixture=Chemical; chemical_name=Hexadecyl trimethyl ammonium chloride; preferred_name=Hexadecyl trimethyl ammonium chloride; dtxsid=DTXSID6026901; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6026901; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 =699 mg/kg bw Rat oral acute Rat Acute Oral Toxicity OECD eChemPortal (undated); record_id=acute_oral_1153; row=10439; data_type=In Vivo; mixture=Chemical; chemical_name=Hexadecyl trimethyl ammonium chloride; preferred_name=Hexadecyl trimethyl ammonium chloride; dtxsid=DTXSID6026901; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6026901; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 =861 mg/kg bw Rat oral acute Rat Acute Oral Toxicity OECD eChemPortal (undated); record_id=acute_oral_1154; row=10441; data_type=In Vivo; mixture=Chemical; chemical_name=Hexadecyl trimethyl ammonium chloride; preferred_name=Hexadecyl trimethyl ammonium chloride; dtxsid=DTXSID6026901; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6026901; source_file=acute_oral.xlsx
NTP ICE skin irritation 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin irritation TER 0.9 kiloohms - Dermal - In Vitro; TER Corrosion sheet=Data_invitro; excel_row=4232; Record_ID=skin_irritation_invitro_2474; Data_Type=In Vitro; Formulation_ID=MIX778; Formulation_Name=Arquad 16-50; Percent_Active_Ingredient=50; Mixture=Mixture; DTXSID=DTXSID6026901; Assay=TER Corrosion; Endpoint=TER; Response=0.9; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6026901
NTP ICE skin irritation TER 1.1 kiloohms - Dermal - In Vitro; TER Corrosion sheet=Data_invitro; excel_row=4227; Record_ID=skin_irritation_invitro_2473; Data_Type=In Vitro; Formulation_ID=MIX778; Formulation_Name=Arquad 16-50; Percent_Active_Ingredient=50; Mixture=Mixture; DTXSID=DTXSID6026901; Assay=TER Corrosion; Endpoint=TER; Response=1.1; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6026901
SCCS Opinion 72 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.052 mg/kg bw/day rat oral - NOAEL study {"dose":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...","effect":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opini","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_005"}
SCCS Opinion NOAEL =0.052 mg/kg bw/day rat oral - NOAEL study {"dose":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...","effect":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opini","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_005"}
SCCS Opinion NOAEL =0.052 mg/kg bw/day rat oral - NOAEL study {"dose":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...","effect":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opini","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_005"}
SCCS Opinion NOAEL =0.052 mg/kg bw/day rat oral - NOAEL study {"dose":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...","effect":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opini","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_005"}
SCCS Opinion NOAEL =0.8 mg/kg rat oral - developmental toxicity {"citation":"Ref.: 42 3","dose":"After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 34 Conclusion Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 42 3.3.9. Toxicokinetics Cetrimonium bromide Isomaa (43) reported a toxicokinetic study in rats using 14C-labeled cetrimonium bromide. After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","page":34,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_004"}
SCCS Opinion NOAEL =0.8 mg/kg rat oral - developmental toxicity {"citation":"Ref.: 42 3","dose":"After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 34 Conclusion Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 42 3.3.9. Toxicokinetics Cetrimonium bromide Isomaa (43) reported a toxicokinetic study in rats using 14C-labeled cetrimonium bromide. After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","page":34,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_004"}
SCCS Opinion NOAEL =0.8 mg/kg rat oral - developmental toxicity {"citation":"Ref.: 42 3","dose":"After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 34 Conclusion Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 42 3.3.9. Toxicokinetics Cetrimonium bromide Isomaa (43) reported a toxicokinetic study in rats using 14C-labeled cetrimonium bromide. After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","page":34,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_004"}
SCCS Opinion NOAEL =0.8 mg/kg rat oral - developmental toxicity {"citation":"Ref.: 42 3","dose":"After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 34 Conclusion Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 42 3.3.9. Toxicokinetics Cetrimonium bromide Isomaa (43) reported a toxicokinetic study in rats using 14C-labeled cetrimonium bromide. After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","page":34,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_004"}
SCCS Opinion NOAEL =2.5 % rat dermal - developmental toxicity {"citation":"Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri","dose":"Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose:","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 33 Conclusion The skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryofoetal toxicity was 40 mg cetrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose: 0.1, 0.9, 1.5 and 2.5% in distilled water at 0.5 ml/rat (approximately 4.5, 7.5, and 12.5 mg/kg bw/day), by dermal a","page":33,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_003"}
SCCS Opinion NOAEL =2.5 % rat dermal - developmental toxicity {"citation":"Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri","dose":"Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose:","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 33 Conclusion The skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryofoetal toxicity was 40 mg cetrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose: 0.1, 0.9, 1.5 and 2.5% in distilled water at 0.5 ml/rat (approximately 4.5, 7.5, and 12.5 mg/kg bw/day), by dermal a","page":33,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_003"}
SCCS Opinion NOAEL =2.5 % rat dermal - developmental toxicity {"citation":"Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri","dose":"Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose:","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 33 Conclusion The skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryofoetal toxicity was 40 mg cetrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose: 0.1, 0.9, 1.5 and 2.5% in distilled water at 0.5 ml/rat (approximately 4.5, 7.5, and 12.5 mg/kg bw/day), by dermal a","page":33,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_003"}
SCCS Opinion NOAEL =2.5 % rat dermal - developmental toxicity {"citation":"Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri","dose":"Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose:","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 33 Conclusion The skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryofoetal toxicity was 40 mg cetrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose: 0.1, 0.9, 1.5 and 2.5% in distilled water at 0.5 ml/rat (approximately 4.5, 7.5, and 12.5 mg/kg bw/day), by dermal a","page":33,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_003"}
SCCS Opinion NOAEL =3.3 - - - - NOAEL study {"effect":"Unlabeled table on page 54: 3.3.14 Discussion","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_015"}
SCCS Opinion NOAEL =3.3 - - - - NOAEL study {"effect":"Unlabeled table on page 54: 3.3.14 Discussion","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_015"}
SCCS Opinion NOAEL =3.3 - - - - NOAEL study {"effect":"Unlabeled table on page 54: 3.3.14 Discussion","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_015"}
SCCS Opinion NOAEL =3.3 - - - - NOAEL study {"effect":"Unlabeled table on page 54: 3.3.14 Discussion","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_015"}
SCCS Opinion NOAEL =9.9 % - dermal - developmental toxicity {"citation":"Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste","effect":"ere no significant differences from concurrent control values in respect of the incidence of malformed or anomalous young or of litters containing affected young. Types of malformations or anomalies observed were within the range of historical control values for this strain. Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, within the limitations of the study, no","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_004"}
SCCS Opinion NOAEL =9.9 % - dermal - developmental toxicity {"citation":"Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste","effect":"ere no significant differences from concurrent control values in respect of the incidence of malformed or anomalous young or of litters containing affected young. Types of malformations or anomalies observed were within the range of historical control values for this strain. Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, within the limitations of the study, no","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_004"}
SCCS Opinion NOAEL =9.9 % - dermal - developmental toxicity {"citation":"Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste","effect":"ere no significant differences from concurrent control values in respect of the incidence of malformed or anomalous young or of litters containing affected young. Types of malformations or anomalies observed were within the range of historical control values for this strain. Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, within the limitations of the study, no","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_004"}
SCCS Opinion NOAEL =9.9 % - dermal - developmental toxicity {"citation":"Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste","effect":"ere no significant differences from concurrent control values in respect of the incidence of malformed or anomalous young or of litters containing affected young. Types of malformations or anomalies observed were within the range of historical control values for this strain. Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, within the limitations of the study, no","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_004"}
SCCS Opinion NOAEL =10 mg/kg rat oral 1-year reproductive toxicity {"dose":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive tox","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_007"}
SCCS Opinion NOAEL =10 mg/kg bw/day - oral 28-day irritation {"citation":"Ref.: 34 (= pp","dose":"There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.","effect":"pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concludes that the toxic response only consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref.: 34 (= pp.170-171 of Ref.1) C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_002"}
SCCS Opinion NOAEL =10 mg/kg rat oral 1-year reproductive toxicity {"dose":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive tox","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_007"}
SCCS Opinion NOAEL =10 mg/kg rat oral 1-year reproductive toxicity {"dose":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive tox","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_007"}
SCCS Opinion NOAEL =10 mg/kg bw/day - oral 28-day irritation {"citation":"Ref.: 34 (= pp","dose":"There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.","effect":"pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concludes that the toxic response only consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref.: 34 (= pp.170-171 of Ref.1) C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_002"}
SCCS Opinion NOAEL =10 mg/kg bw/day - oral 28-day irritation {"citation":"Ref.: 34 (= pp","dose":"There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.","effect":"pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concludes that the toxic response only consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref.: 34 (= pp.170-171 of Ref.1) C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_002"}
SCCS Opinion NOAEL =10 mg/kg rat oral 1-year reproductive toxicity {"dose":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive tox","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_007"}
SCCS Opinion NOAEL =10 mg/kg bw/day - oral 28-day irritation {"citation":"Ref.: 34 (= pp","dose":"There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.","effect":"pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concludes that the toxic response only consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref.: 34 (= pp.170-171 of Ref.1) C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_002"}
SCCS Opinion NOAEL =12.5 mg/kg bw/day rat dermal developmental developmental toxicity {"citation":"Ref.: 41 (= pp","dose":"as observed primarily in the mid and high dose groups.","effect":"as observed primarily in the mid and high dose groups. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed in the high dose group at necropsy. The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (= pp.222-224 of Ref.1) B. Steartrimonium chloride - dermal administration, rat 20 mated female Sprague Dawley rats per group are reported to be exposed for days 6 to 15 of gestation to steartrimonium chloride at dosage levels of 4.5, 7.5 and 12.5 mg/kg bw/day. The test substance was applied with a syringe and gently massaged into the shaved area (4 x 4 cm) of skin in the scapula region for no","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_003"}
SCCS Opinion NOAEL =12.5 mg/kg bw/day rat dermal developmental developmental toxicity {"citation":"Ref.: 41 (= pp","dose":"as observed primarily in the mid and high dose groups.","effect":"as observed primarily in the mid and high dose groups. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed in the high dose group at necropsy. The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (= pp.222-224 of Ref.1) B. Steartrimonium chloride - dermal administration, rat 20 mated female Sprague Dawley rats per group are reported to be exposed for days 6 to 15 of gestation to steartrimonium chloride at dosage levels of 4.5, 7.5 and 12.5 mg/kg bw/day. The test substance was applied with a syringe and gently massaged into the shaved area (4 x 4 cm) of skin in the scapula region for no","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_003"}
SCCS Opinion NOAEL =12.5 mg/kg bw/day rat dermal developmental developmental toxicity {"citation":"Ref.: 41 (= pp","dose":"as observed primarily in the mid and high dose groups.","effect":"as observed primarily in the mid and high dose groups. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed in the high dose group at necropsy. The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (= pp.222-224 of Ref.1) B. Steartrimonium chloride - dermal administration, rat 20 mated female Sprague Dawley rats per group are reported to be exposed for days 6 to 15 of gestation to steartrimonium chloride at dosage levels of 4.5, 7.5 and 12.5 mg/kg bw/day. The test substance was applied with a syringe and gently massaged into the shaved area (4 x 4 cm) of skin in the scapula region for no","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_003"}
SCCS Opinion NOAEL =12.5 mg/kg bw/day rat dermal developmental developmental toxicity {"citation":"Ref.: 41 (= pp","dose":"as observed primarily in the mid and high dose groups.","effect":"as observed primarily in the mid and high dose groups. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed in the high dose group at necropsy. The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (= pp.222-224 of Ref.1) B. Steartrimonium chloride - dermal administration, rat 20 mated female Sprague Dawley rats per group are reported to be exposed for days 6 to 15 of gestation to steartrimonium chloride at dosage levels of 4.5, 7.5 and 12.5 mg/kg bw/day. The test substance was applied with a syringe and gently massaged into the shaved area (4 x 4 cm) of skin in the scapula region for no","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_003"}
SCCS Opinion NOAEL =24 % rabbit dermal 28-day irritation {"citation":"Ref.: 33 B","dose":"Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.","effect":"l results revealed no treatment-related changes in any group. Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of some systemic toxicity. As such, the dosage of 100 mg/kg bw/day was considered to be the no-observed-effect- level (NOEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 hours. Body hair was clipped as needed on approximately 25% of the","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_001"}
SCCS Opinion NOAEL =24 % rabbit dermal 28-day irritation {"citation":"Ref.: 33 B","dose":"Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.","effect":"l results revealed no treatment-related changes in any group. Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of some systemic toxicity. As such, the dosage of 100 mg/kg bw/day was considered to be the no-observed-effect- level (NOEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 hours. Body hair was clipped as needed on approximately 25% of the","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_001"}
SCCS Opinion NOAEL =24 % rabbit dermal 28-day irritation {"citation":"Ref.: 33 B","dose":"Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.","effect":"l results revealed no treatment-related changes in any group. Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of some systemic toxicity. As such, the dosage of 100 mg/kg bw/day was considered to be the no-observed-effect- level (NOEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 hours. Body hair was clipped as needed on approximately 25% of the","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_001"}
SCCS Opinion NOAEL =24 % rabbit dermal 28-day irritation {"citation":"Ref.: 33 B","dose":"Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.","effect":"l results revealed no treatment-related changes in any group. Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of some systemic toxicity. As such, the dosage of 100 mg/kg bw/day was considered to be the no-observed-effect- level (NOEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 hours. Body hair was clipped as needed on approximately 25% of the","page":35,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_001"}
SCCS Opinion NOAEL =40 - rat dermal Developmental developmental toxicity {"dose":"Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed.","effect":"cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_010"}
SCCS Opinion NOAEL =40 - rat dermal Developmental developmental toxicity {"dose":"Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed.","effect":"cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_010"}
SCCS Opinion NOAEL =40 - rat dermal Developmental developmental toxicity {"dose":"Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed.","effect":"cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_010"}
SCCS Opinion NOAEL =40 - rat dermal Developmental developmental toxicity {"dose":"Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed.","effect":"cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_010"}
SCCS Opinion NOAEL =41 - - - - developmental toxicity {"effect":"Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_012"}
SCCS Opinion NOAEL =41 - - - - developmental toxicity {"effect":"Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_012"}
SCCS Opinion NOAEL =41 - - - - developmental toxicity {"effect":"Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_012"}
SCCS Opinion NOAEL =41 - - - - developmental toxicity {"effect":"Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity","page":41,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_012"}
SCCS Opinion NOAEL =42 - - - - developmental toxicity {"effect":"Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_013"}
SCCS Opinion NOAEL =42 - - - - developmental toxicity {"effect":"Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_013"}
SCCS Opinion NOAEL =42 - - - - developmental toxicity {"effect":"Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_013"}
SCCS Opinion NOAEL =42 - - - - developmental toxicity {"effect":"Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was","page":42,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_013"}
SCCS Opinion NOAEL =45 mg/kg rat oral 28-day irritation {"dose":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract obser","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_006"}
SCCS Opinion NOAEL =45 mg/kg rat oral 28-day irritation {"dose":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract obser","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_006"}
SCCS Opinion NOAEL =45 mg/kg rat oral 28-day irritation {"dose":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract obser","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_006"}
SCCS Opinion NOAEL =45 mg/kg rat oral 28-day irritation {"dose":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","effect":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract obser","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_006"}
SCCS Opinion NOAEL =54 - - - - NOAEL study {"effect":"Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_014"}
SCCS Opinion NOAEL =54 - - - - NOAEL study {"effect":"Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_014"}
SCCS Opinion NOAEL =54 - - - - NOAEL study {"effect":"Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_014"}
SCCS Opinion NOAEL =54 - - - - NOAEL study {"effect":"Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192","page":54,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_014"}
SCCS Opinion NOAEL =100 mg/kg bw/day rabbit dermal Subacute repeated dose toxicity {"citation":"Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy","dose":"No macroscopic or microscopic alterations were found in the mid and low dose groups.","effect":"r organs. No macroscopic or microscopic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5","page":26,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_001"}
SCCS Opinion NOAEL =100 mg/kg rat oral 28-day irritation {"dose":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and s...","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_005"}
SCCS Opinion NOAEL =100 mg/kg/day rat oral 1-year reproductive toxicity {"dose":"In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity.","effect":"as been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive toxicity It was not possible to evaluate the studies as only summaries were provided. Skin irritation The results of available skin irritation studies in rabbits are shown in the table. Substance Expos","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_008"}
SCCS Opinion NOAEL =100 mg/kg bw/day rat oral 28-day repeated dose toxicity {"dose":"A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects.","effect":"Within three days of ingestion 92% of the radioactivity was excreted via the faeces and 1% via urine. A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects. Slight weight changes in adrenals and spleen and an increase in alanine transaminase (ALT) levels were regarded as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicat","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_007"}
SCCS Opinion NOAEL =100 mg/kg bw/day rabbit dermal Subacute repeated dose toxicity {"citation":"Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy","dose":"No macroscopic or microscopic alterations were found in the mid and low dose groups.","effect":"r organs. No macroscopic or microscopic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5","page":26,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_001"}
SCCS Opinion NOAEL =100 mg/kg rat oral 28-day irritation {"dose":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and s...","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_005"}
SCCS Opinion NOAEL =100 mg/kg/day rat oral 1-year reproductive toxicity {"dose":"In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity.","effect":"as been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive toxicity It was not possible to evaluate the studies as only summaries were provided. Skin irritation The results of available skin irritation studies in rabbits are shown in the table. Substance Expos","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_008"}
SCCS Opinion NOAEL =100 mg/kg bw/day rabbit dermal Subacute repeated dose toxicity {"citation":"Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy","dose":"No macroscopic or microscopic alterations were found in the mid and low dose groups.","effect":"r organs. No macroscopic or microscopic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5","page":26,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_001"}
SCCS Opinion NOAEL =100 mg/kg rat oral 28-day irritation {"dose":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and s...","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_005"}
SCCS Opinion NOAEL =100 mg/kg/day rat oral 1-year reproductive toxicity {"dose":"In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity.","effect":"as been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive toxicity It was not possible to evaluate the studies as only summaries were provided. Skin irritation The results of available skin irritation studies in rabbits are shown in the table. Substance Expos","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_008"}
SCCS Opinion NOAEL =100 mg/kg bw/day rat oral 28-day repeated dose toxicity {"dose":"A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects.","effect":"Within three days of ingestion 92% of the radioactivity was excreted via the faeces and 1% via urine. A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects. Slight weight changes in adrenals and spleen and an increase in alanine transaminase (ALT) levels were regarded as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicat","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_007"}
SCCS Opinion NOAEL =100 mg/kg bw/day rat oral 28-day repeated dose toxicity {"dose":"A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects.","effect":"Within three days of ingestion 92% of the radioactivity was excreted via the faeces and 1% via urine. A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects. Slight weight changes in adrenals and spleen and an increase in alanine transaminase (ALT) levels were regarded as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicat","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_007"}
SCCS Opinion NOAEL =100 mg/kg bw/day rabbit dermal Subacute repeated dose toxicity {"citation":"Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy","dose":"No macroscopic or microscopic alterations were found in the mid and low dose groups.","effect":"r organs. No macroscopic or microscopic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5","page":26,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_001"}
SCCS Opinion NOAEL =100 mg/kg rat oral 28-day irritation {"dose":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and s...","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_005"}
SCCS Opinion NOAEL =100 mg/kg/day rat oral 1-year reproductive toxicity {"dose":"In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity.","effect":"as been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive toxicity It was not possible to evaluate the studies as only summaries were provided. Skin irritation The results of available skin irritation studies in rabbits are shown in the table. Substance Expos","page":39,"pdf":"sccp_o_037.pdf","row_type":"noael_study","study_id":"sccp_o_037_noael_008"}
SCCS Opinion NOAEL =100 mg/kg bw/day rat oral 28-day repeated dose toxicity {"dose":"A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects.","effect":"Within three days of ingestion 92% of the radioactivity was excreted via the faeces and 1% via urine. A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects. Slight weight changes in adrenals and spleen and an increase in alanine transaminase (ALT) levels were regarded as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicat","page":55,"pdf":"sccp_o_096.pdf","row_type":"noael_study","study_id":"sccp_o_096_noael_007"}
ECHA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL =10 mg/kg bw/day Rabbit dermal short-term; 4 weeks short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61f08e4b096bca877c1b0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10710/7/6/4?documentUUID=df38ce97-5012-4cd1-8ee2-d5c3508f6e8b; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15826728:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ce3d3371c9c5a37d443122820255266b
ECHA NOEL ~40 mg/kg bw/day Rabbit dermal - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d18ae4b0a7c65d22f12d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10710/7/9/3?documentUUID=df38ce97-5012-4cd1-8ee2-d5c3508f6e8b; YEAR=1976; ORIGINAL_YEAR=1976; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: changes in sex ratio|fetus: fetal/pup body weight changes|fetus: changes in litter size and weights|fetus: changes in postnatal survival|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821800:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_09623835eed21ef3f8db63c3e57c20f3
ECHA NOEL ~100 mg/kg bw/day Rat oral short-term; 28 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaebde4b0a7c65d1cab82; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/14334?documentUUID=d22bd67a-3932-4249-a7a3-4f65c137d867; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15833159:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ff29f572e898dfc87d7732c40be53891
ToxValDB ECOTOX 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX LOEL =400 mg/kg bw/day Mouse oral short-term; 7 days short-term LONG_REF=EPA/OTS Doc.#88-920006818:21 p. Proctor and Gamble Co. Initial Submission: Letter from Procter & Gamble Company to U.S.EPA Submitting Information on the Enclosed Ammonium Compounds & Alkylethoxylates Report with Attachments 1992; TITLE=Initial Submission: Letter from Procter & Gamble Company to U.S.EPA Submitting Information on the Enclosed Ammonium Compounds & Alkylethoxylates Report with Attachments; AUTHOR=Proctor and Gamble Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=81224; 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=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Mortality: Mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600180_15600181_15600182:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=e503ff4fa2b6a48efda974b352c1c46b
ToxValDB ECOTOX LOEL =600 mg/kg bw/day Mouse oral short-term; 7 days short-term LONG_REF=EPA/OTS Doc.#88-920006818:21 p. Proctor and Gamble Co. Initial Submission: Letter from Procter & Gamble Company to U.S.EPA Submitting Information on the Enclosed Ammonium Compounds & Alkylethoxylates Report with Attachments 1992; TITLE=Initial Submission: Letter from Procter & Gamble Company to U.S.EPA Submitting Information on the Enclosed Ammonium Compounds & Alkylethoxylates Report with Attachments; AUTHOR=Proctor and Gamble Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=81224; 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=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Behavior: Righting response|Intoxication: Ataxia; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|neurobehavior; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600180_15600181_15600182:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b6988e034ac5aeffc90cb2868f894dde
ToxValDB ECOTOX NOEL =300 mg/kg bw/day Mouse oral short-term; 7 days short-term LONG_REF=EPA/OTS Doc.#88-920006818:21 p. Proctor and Gamble Co. Initial Submission: Letter from Procter & Gamble Company to U.S.EPA Submitting Information on the Enclosed Ammonium Compounds & Alkylethoxylates Report with Attachments 1992; TITLE=Initial Submission: Letter from Procter & Gamble Company to U.S.EPA Submitting Information on the Enclosed Ammonium Compounds & Alkylethoxylates Report with Attachments; AUTHOR=Proctor and Gamble Co.; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=81224; 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=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Behavior: Behavioral changes, general; TOXICOLOGICAL_EFFECT_CATEGORY=neurobehavior; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600180_15600181_15600182:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=c6178a23e591abe6d6fbddafcb03c87e
Regulatory source 23 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - =0.052 mg/kg bw/day rat oral - - SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.052; DOSE=SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...; EFFECT=SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opini; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...","duration":"","effect":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opini","endpoint":"","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 0.052","page":54,"route":"oral","species":"rat","study_id":"sccp_o_096_noael_005"}
Regulatory source - 3.3 - - - - - SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=3.3.14 Discussion; EFFECT=Unlabeled table on page 54: 3.3.14 Discussion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 54: 3.3.14 Discussion","endpoint":"","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"","noael_value":"3.3.14 Discussion","page":54,"route":"","species":"","study_id":"sccp_o_096_noael_015"}
Regulatory source - =10 mg/kg bw/day rat oral - - SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 10; DOSE=SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...; EFFECT=SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opinion sum; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x...","duration":"","effect":"SCCP/0000/00 Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses 54 CALCULATION OF THE MARGIN OF SAFETY Maximum amount of ingredient applied daily = 99.1 mg/day Typical human body weight = 60kg Maximum absorption through the skin = 3.15% (in vivo rat study laurtrimonium bromide) Systemic exposure dose (SED) (99.1 x 3/100) / 60 = 0.052 mg/kg bw/day No observed adverse effect level NOAEL = 10 mg/kg bw/day (12m-oral-rat) Margin of Safety NOAEL / SED = 192 3.3.14 Discussion It is the opinion of the SCCP that the submission lacks a number of data with respect to the identification, stability and physico-chemical data of the three quaternary ammonium compounds under study. The lacking data as mentioned in the present opinion as General comments on Section 3.1 are required for completion of the dossier. With regard to the toxicological properties of P72, the table in the Annex to this opinion sum","endpoint":"","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 10","page":54,"route":"oral","species":"rat","study_id":"sccp_o_096_noael_006"}
Regulatory source - 54 - - - - - SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192; EFFECT=Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192","endpoint":"","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 54: Margin of Safety NOAEL / SED = 192","page":54,"route":"","species":"","study_id":"sccp_o_096_noael_014"}
Regulatory source developmental toxicity 0.8 mg/kg rat oral - developmental toxicity SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=0.8; DOSE=After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts; EFFECT=SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 34 Conclusion Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 42 3.3.9. Toxicokinetics Cetrimonium bromide Isomaa (43) reported a toxicokinetic study in rats using 14C-labeled cetrimonium bromide. After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts; CITATION=Ref.: 42 3; CITATION_NUMBERS=[42,3]; REFERENCE=Ref.: 42 3; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 42 3","dose":"After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","duration":"","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 34 Conclusion Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 42 3.3.9. Toxicokinetics Cetrimonium bromide Isomaa (43) reported a toxicokinetic study in rats using 14C-labeled cetrimonium bromide. After administration of 0.8 mg/kg by oral gavage, about 80% of the dose of radioactivity was found in the gastrointestinal tract 8 hours after the administration, only small amounts","endpoint":"developmental toxicity","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"0.8","page":34,"route":"oral","species":"rat","study_id":"sccp_o_037_noael_004"}
Regulatory source developmental toxicity 2.5 % rat dermal - developmental toxicity SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=2.5; DOSE=Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose:; EFFECT=SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 33 Conclusion The skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryofoetal toxicity was 40 mg cetrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose: 0.1, 0.9, 1.5 and 2.5% in distilled water at 0.5 ml/rat (approximately 4.5, 7.5, and 12.5 mg/kg bw/day), by dermal a; CITATION=Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri; CITATION_NUMBERS=[41,20]; REFERENCE=Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartri","dose":"Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose:","duration":"","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 33 Conclusion The skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryofoetal toxicity was 40 mg cetrimonium chloride/kg bw/day. Comment It was not possible to evaluate the study as only a summary was provided. Ref.: 41 b) Steartrimonium chloride Guideline: / Species/strain: CFY Sprague-Dawley rat Group size: 20 mated female rats/group Test substance: Trimethylstearylammonium chloride (steartrimonium chloride) Batch: / Dose: 0.1, 0.9, 1.5 and 2.5% in distilled water at 0.5 ml/rat (approximately 4.5, 7.5, and 12.5 mg/kg bw/day), by dermal a","endpoint":"developmental toxicity","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"%","noael_value":"2.5","page":33,"route":"dermal","species":"rat","study_id":"sccp_o_037_noael_003"}
Regulatory source developmental toxicity 9.9 % - dermal - developmental toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=9.9; EFFECT=ere no significant differences from concurrent control values in respect of the incidence of malformed or anomalous young or of litters containing affected young. Types of malformations or anomalies observed were within the range of historical control values for this strain. Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, within the limitations of the study, no; CITATION=Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste; CITATION_NUMBERS=[1,1983]; REFERENCE=Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylste","dose":"","duration":"","effect":"ere no significant differences from concurrent control values in respect of the incidence of malformed or anomalous young or of litters containing affected young. Types of malformations or anomalies observed were within the range of historical control values for this strain. Skin changes at the application sites were considered to be a result of local irritation and not indicative of systemic toxicity. Under the test conditions used, steartrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was about 12.5 mg steartrimonium chloride/kg bw/day (highest concentration tested). Ref.: 1 A publication of 1983 summarizes a study in which the potential embryotoxic effects of dimethyldistearylammonium chloride, benzyldimethylstearylammonium chloride and trimethylstearylammonium chloride were investigated upon topical application of concentrations up to 9.9%, 6.6% and 2.5%, respectively. The authors conclude that, within the limitations of the study, no","endpoint":"developmental toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"%","noael_value":"9.9","page":42,"route":"dermal","species":"","study_id":"sccp_o_096_noael_004"}
Regulatory source developmental toxicity 10 mg/kg bw/day rat oral chronic developmental toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=10; DOSE=None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day, which can considered to be the NOAEL of cetrimonium bromide.; EFFECT=rimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day, which can considered to be the NOAEL of cetrimonium bromide. Genotoxicity The presented mutagenicity studies (Ames tests for the three compounds under study and a chromosome aberration test and in vitro Syrian hamster cell transformation assay for cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day, which can considered to be the NOAEL of cetrimonium bromide.","duration":"chronic","effect":"rimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day, which can considered to be the NOAEL of cetrimonium bromide. Genotoxicity The presented mutagenicity studies (Ames tests for the three compounds under study and a chromosome aberration test and in vitro Syrian hamster cell transformation assay for cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased in","endpoint":"developmental toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":55,"route":"oral","species":"rat","study_id":"sccp_o_096_noael_009"}
Regulatory source developmental toxicity 12.5 mg/kg bw/day rat dermal developmental developmental toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=12.5; DOSE=as observed primarily in the mid and high dose groups.; EFFECT=as observed primarily in the mid and high dose groups. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed in the high dose group at necropsy. The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (= pp.222-224 of Ref.1) B. Steartrimonium chloride - dermal administration, rat 20 mated female Sprague Dawley rats per group are reported to be exposed for days 6 to 15 of gestation to steartrimonium chloride at dosage levels of 4.5, 7.5 and 12.5 mg/kg bw/day. The test substance was applied with a syringe and gently massaged into the shaved area (4 x 4 cm) of skin in the scapula region for no; CITATION=Ref.: 41 (= pp; CITATION_NUMBERS=[41]; REFERENCE=Ref.: 41 (= pp; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 41 (= pp","dose":"as observed primarily in the mid and high dose groups.","duration":"developmental","effect":"as observed primarily in the mid and high dose groups. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed in the high dose group at necropsy. The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the test conditions used, cetrimonium chloride was found to be non-foetotoxic and non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day. Ref.: 41 (= pp.222-224 of Ref.1) B. Steartrimonium chloride - dermal administration, rat 20 mated female Sprague Dawley rats per group are reported to be exposed for days 6 to 15 of gestation to steartrimonium chloride at dosage levels of 4.5, 7.5 and 12.5 mg/kg bw/day. The test substance was applied with a syringe and gently massaged into the shaved area (4 x 4 cm) of skin in the scapula region for no","endpoint":"developmental toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"12.5","page":41,"route":"dermal","species":"rat","study_id":"sccp_o_096_noael_003"}
Regulatory source developmental toxicity 40 - rat dermal Developmental developmental toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo; DOSE=Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed.; EFFECT=cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed.","duration":"Developmental","effect":"cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo","endpoint":"developmental toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"","noael_value":"unclear:cetrimonium chloride only) were all negative. Testing was limited to low concentrations due to the high cytotoxicity. Developmental toxicity Finally, dermal developmental toxicity studies with cetrimonium chloride in the rabbit and the rat revealed dose-dependent irritative effects, though no increased incidence of foetal malformations nor developmental variations in the treated groups compared to controls were observed. Cetrimonium chloride was found to be non-foetotoxic and non-teratogenic in both species. The NOEL for maternal systemic toxicity and embryo-foetal toxicity appeared to be 40 mg cetrimonium chloride/kg bw/day for the rabbit and 12.5 mg cetrimonium chloride/kg bw/day for the rat. Local toxicity As is the case for the majority of quaternary ammonium compounds, concentrated cetrimonium chloride, steartrimonium chloride and behentrimonium chloride are corrosive to skin and eyes. This is confirmed by the presented skin and eye irritation studies on rabbits with different formulations containing the quaternary ammo","page":55,"route":"dermal","species":"rat","study_id":"sccp_o_096_noael_010"}
Regulatory source developmental toxicity 41 - - - - developmental toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity; EFFECT=Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity","endpoint":"developmental toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 41: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity","page":41,"route":"","species":"","study_id":"sccp_o_096_noael_012"}
Regulatory source developmental toxicity 42 - - - - developmental toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was; EFFECT=Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was","endpoint":"developmental toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 42: non-teratogenic. The NOEL for maternal systemic toxicity and embryo-foetal toxicity was","page":42,"route":"","species":"","study_id":"sccp_o_096_noael_013"}
Regulatory source irritation 10 mg/kg bw/day - oral 28-day irritation SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=10; DOSE=There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.; EFFECT=pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concludes that the toxic response only consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref.: 34 (= pp.170-171 of Ref.1) C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted; CITATION=Ref.: 34 (= pp; CITATION_NUMBERS=[34]; REFERENCE=Ref.: 34 (= pp; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 34 (= pp","dose":"There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate.","duration":"28-day","effect":"pically disappeared by the end of the study. There were no treatment-related effects on body weight, haematology, organ weight, gross necropsy findings or histopathology, except for treated areas of the skin that showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. The US National Toxicology Programme report concludes that the toxic response only consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic effects. Ref.: 34 (= pp.170-171 of Ref.1) C. Steartrimonium chloride - 28-day oral/dermal administration No data submitted","endpoint":"irritation","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":35,"route":"oral","species":"","study_id":"sccp_o_096_noael_002"}
Regulatory source irritation 10 mg/kg bw/day - - - irritation SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=10; DOSE=Unlabeled table on page 35: consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic; EFFECT=Unlabeled table on page 35: consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"Unlabeled table on page 35: consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic","duration":"","effect":"Unlabeled table on page 35: consists of skin irritation, and proposes a NOAEL value of 10 mg/kg bw/day for systemic","endpoint":"irritation","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":35,"route":"","species":"","study_id":"sccp_o_096_noael_011"}
Regulatory source irritation 24 % rabbit dermal 28-day irritation SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=24-26; DOSE=Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.; EFFECT=l results revealed no treatment-related changes in any group. Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of some systemic toxicity. As such, the dosage of 100 mg/kg bw/day was considered to be the no-observed-effect- level (NOEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 hours. Body hair was clipped as needed on approximately 25% of the; CITATION=Ref.: 33 B; CITATION_NUMBERS=[33]; REFERENCE=Ref.: 33 B; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 33 B","dose":"Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity.","duration":"28-day","effect":"l results revealed no treatment-related changes in any group. Conclusion The study authors conclude that the forestomach and stomach changes observed at 300 mg/kg bw/day can be considered to be a result of local irritation and therefore are not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of some systemic toxicity. As such, the dosage of 100 mg/kg bw/day was considered to be the no-observed-effect- level (NOEL) of Dehyquart A-CA (24-26% cetrimonium chloride in water) in this study. Ref.: 33 B. Cetrimonium chloride - 28-day dermal administration in the rabbit In a study from 1978, 5 New Zealand albino rabbits/sex/group were treated cutaneously with the test substance for 5 days/week for 4 weeks at a dose of 0 or 10 mg/kg bw/day (0 or 0.5% aqueous solutions, respectively). The dosage volume was 2.0 ml/kg bw with an approximate exposure period of 6.5 to 7 hours. Body hair was clipped as needed on approximately 25% of the","endpoint":"irritation","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"%","noael_value":"24-26","page":35,"route":"dermal","species":"rabbit","study_id":"sccp_o_096_noael_001"}
Regulatory source irritation 45 mg/kg rat oral 28-day irritation SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=45; DOSE=__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.; EFFECT=__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract obser; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","duration":"28-day","effect":"__________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract obser","endpoint":"irritation","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"45","page":39,"route":"oral","species":"rat","study_id":"sccp_o_037_noael_006"}
Regulatory source irritation 100 mg/kg rat oral 28-day irritation SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=100; DOSE=SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and s...; EFFECT=SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and s...","duration":"28-day","effect":"SCCP/0917/05 Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride for other uses than as a preservative ____________________________________________________________________________________________ 39 Repeated-dose toxicity In the 28-day oral gavage study in rats using cetrimonium chloride, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of","endpoint":"irritation","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":39,"route":"oral","species":"rat","study_id":"sccp_o_037_noael_005"}
Regulatory source repeated dose toxicity 10 mg/kg bw/day rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=10; DOSE=as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day).; EFFECT=as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day, whic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day).","duration":"28-day","effect":"as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicated that the test compound may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or by interfering with the absorption of nutritional substances and reduced skeletal growth. The males displayed a reduced relative liver weight. None of these effects was observed at the lowest tested dosage level of 10 mg/kg bw/day, whic","endpoint":"repeated dose toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":55,"route":"oral","species":"rat","study_id":"sccp_o_096_noael_008"}
Regulatory source repeated dose toxicity 100 mg/kg bw/day rabbit dermal Subacute repeated dose toxicity SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=100; DOSE=No macroscopic or microscopic alterations were found in the mid and low dose groups.; EFFECT=r organs. No macroscopic or microscopic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5; CITATION=Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy; CITATION_NUMBERS=[33,5]; REFERENCE=Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy","dose":"No macroscopic or microscopic alterations were found in the mid and low dose groups.","duration":"Subacute","effect":"r organs. No macroscopic or microscopic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5","endpoint":"repeated dose toxicity","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":26,"route":"dermal","species":"rabbit","study_id":"sccp_o_037_noael_001"}
Regulatory source repeated dose toxicity 100 mg/kg bw/day rabbit dermal Subacute repeated dose toxicity SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=100; DOSE=copic alterations were found in the mid and low dose groups.; EFFECT=copic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5 days/w; CITATION=Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy; CITATION_NUMBERS=[33,5]; REFERENCE=Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy; DETAILS_JSON={"cas_number":"112-02-7","citation":"Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethy","dose":"copic alterations were found in the mid and low dose groups.","duration":"Subacute","effect":"copic alterations were found in the mid and low dose groups. All treatment-related changes were shown to be reversible following the recovery period. Conclusion The forestomach and stomach changes are considered to be a result of local irritation and not indicative of systemic toxicity. The slight weight changes of spleen and adrenals and the increase in serum ALT activity were regarded as a possible sign of minimal systemic toxicity. As such, the dose of 100 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) in this study. Ref.: 33 Subacute dermal toxicity in rabbits Guideline: / Species/strain: New Zealand White rabbits Group size: 5 males and 5 females per dose Test substance: Ammonium, hexadecyltrimethyl-, chloride 54.5% in aqueous isopropanol Batch: not stated Dose: 0 and 0.5 % w/v: 2 ml/kg (10 mg cetrimonium chloride/kg bw/day) in distilled water for 6.5-7 hours/day, 5 days/week by dermal application Exposure: 4 weeks GLP: / Five rabbits/sex/group were treated cutaneously with the test substance for 5 days/w","endpoint":"repeated dose toxicity","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":26,"route":"dermal","species":"rabbit","study_id":"sccp_o_037_noael_002"}
Regulatory source repeated dose toxicity 100 mg/kg bw/day rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_096; REPORT_TITLE=OPINION ON ALKYL (C16, C18, C22) TRIMETHYLAMMONIUM CHLORIDE For other uses than as a preservative COLIPA n° P72; OPINION_NUMBER=SCCP/0000/00; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects.; EFFECT=Within three days of ingestion 92% of the radioactivity was excreted via the faeces and 1% via urine. A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects. Slight weight changes in adrenals and spleen and an increase in alanine transaminase (ALT) levels were regarded as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects.","duration":"28-day","effect":"Within three days of ingestion 92% of the radioactivity was excreted via the faeces and 1% via urine. A 28-day oral repeated dose toxicity study revealed cetrimonium chloride to cause significant forestomach and stomach changes caused by its irritative effects. Slight weight changes in adrenals and spleen and an increase in alanine transaminase (ALT) levels were regarded as possible signs of systemic toxicity and occurred at the highest dosage level tested (300 mg/kg bw/day). 100 mg/kg bw/day was regarded as the NOEL value for Dehyquart A-CA, corresponding to 24-26 mg cetrimonium chloride/kg bw/day. A 28-day dermal repeated dose toxicity study revealed that the only tested dosage of 10 mg cetrimonium chloride/kg bw/day caused no systemic toxicity, but it did cause a number of local effects on the skin at the only tested dose of 0.5%. 10 mg/kg bw/day was thus determined to be the NOAEL (28-dermal-rabbit) for cetrimonium chloride for systemic effects. A chronic (12 months) oral study with cetrimonium bromide in the rat indicat","endpoint":"repeated dose toxicity","ingredient":"s indicated by (+) in Annex VI, when incorporated into cosmetic formulations for","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":55,"route":"oral","species":"rat","study_id":"sccp_o_096_noael_007"}
Regulatory source reproductive toxicity 10 mg/kg rat oral 1-year reproductive toxicity SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=10; DOSE=ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.; EFFECT=ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive tox; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day.","duration":"1-year","effect":"ide, local effects in the gastrointestinal tract and slight effects on organ weights without histopathological correlates were observed at a dose of 300 mg/kg b.w./day. A dose of 100 mg/kg b.w./day has been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive tox","endpoint":"reproductive toxicity","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg","noael_value":"10","page":39,"route":"oral","species":"rat","study_id":"sccp_o_037_noael_007"}
Regulatory source reproductive toxicity 100 mg/kg/day rat oral 1-year reproductive toxicity SOURCE_SUBDIR=sccp_o_037; REPORT_TITLE=Opinion on Alkyl (C16, C18, C22) trimethylammonium chloride For other uses than as a preservative; OPINION_NUMBER=SCCP/0917/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=17 March 2006; VALUE_TEXT=100; DOSE=In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity.; EFFECT=as been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive toxicity It was not possible to evaluate the studies as only summaries were provided. Skin irritation The results of available skin irritation studies in rabbits are shown in the table. Substance Expos; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-02-7","citation":"","dose":"In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity.","duration":"1-year","effect":"as been considered as the NOEL. In the 1-year chronic study in rats receiving cetrimonium bromide in the drinking water, the highest dose of 45 mg/kg b.w./day was a NOAEL for systemic toxicity. However, this dose produced local effects in the gastrointestinal tract secondary to the irritant nature of the substance. The NOEL in this study was 10 mg/kg b.w./day. A dose of 10 mg/kg/day was also tested in a 28-day repeated dermal toxicity study in rabbits and produced no systemic toxicity. For the MOS calculation, the NOAEL for systemic effects of 100 mg/kg/day from the 28-day study or 45 mg/kg/day from the 1-year study may be used, since the effects on the gastrointestinal tract observed in the studies are considered to be related to the oral exposure route and irrelevant for the risk assessment of topical application. Reproductive toxicity It was not possible to evaluate the studies as only summaries were provided. Skin irritation The results of available skin irritation studies in rabbits are shown in the table. Substance Expos","endpoint":"reproductive toxicity","ingredient":"a) cetrimonium chloride","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":39,"route":"oral","species":"rat","study_id":"sccp_o_037_noael_008"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier UC9PE95IBP UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H42N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UC9PE95IBP"}
openFDA substances FDA UNII substance identifier UC9PE95IBP UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H42N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UC9PE95IBP"}
openFDA substances FDA UNII substance identifier UC9PE95IBP UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H42N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UC9PE95IBP"}
openFDA substances FDA UNII substance identifier UC9PE95IBP UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H42N.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"UC9PE95IBP"}