NOAEL Studies Cosmetic Ingredient

Bishydroxyethyl Biscetyl Malonamide NOAEL Studies

INCI: BISHYDROXYETHYL BISCETYL MALONAMIDE

CAS: 149591-38-8

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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COSMOS DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 150 mg/kg bw/day rat oral 28 day Short Term Toxicity SCCP; Lea L & Spurgeon M (1994) Pseudoceramide H: 28-Day Subacute Oral Toxicity Study inRats, Project No. GF930518, EnvironmentalSafety Laboratory, Unilever Research,Bedford, England
COSMOS DB NOAEL 15 mg/kg bw/day rat oral 28 day Short Term Toxicity SCCP; Lea L & Spurgeon M (1994) Pseudoceramide H: 28-Day Subacute Oral Toxicity Study inRats, Project No. GF930518, EnvironmentalSafety Laboratory, Unilever Research,Bedford, England
SCCS Opinion 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =15 mg/kg/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 8 3","dose":"Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus.","effect":"male animal were considered to be consistent with this microscopic finding. Genital tract and liver changes similar to those seen after treatment with bishydroxyethyl biscetyl malonamide can occur in control animals. It was considered to be possible that a chance imbalanced incidence of these background findings resulted in an apparently treatment-related distribution, a problem exacerbated by the small group size and known to occur in tissues such as the genital tract, which undergo cyclic changes. Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus. Ref.: 8 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Salmonella typhimurium Reverse Mutation Assay Guideline : / Substance : Questamide H sample no S1999201, purity > 99% Test fo","page":11,"pdf":"sccp_o_021.pdf","row_type":"noael_study","study_id":"sccp_o_021_noael_001"}
SCCS Opinion NOAEL =15 mg/kg/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 8 3","dose":"Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus.","effect":"male animal were considered to be consistent with this microscopic finding. Genital tract and liver changes similar to those seen after treatment with bishydroxyethyl biscetyl malonamide can occur in control animals. It was considered to be possible that a chance imbalanced incidence of these background findings resulted in an apparently treatment-related distribution, a problem exacerbated by the small group size and known to occur in tissues such as the genital tract, which undergo cyclic changes. Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus. Ref.: 8 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Salmonella typhimurium Reverse Mutation Assay Guideline : / Substance : Questamide H sample no S1999201, purity > 99% Test fo","page":11,"pdf":"sccp_o_021.pdf","row_type":"noael_study","study_id":"sccp_o_021_noael_001"}
SCCS Opinion NOAEL =15 mg/kg/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 8 3","dose":"Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus.","effect":"male animal were considered to be consistent with this microscopic finding. Genital tract and liver changes similar to those seen after treatment with bishydroxyethyl biscetyl malonamide can occur in control animals. It was considered to be possible that a chance imbalanced incidence of these background findings resulted in an apparently treatment-related distribution, a problem exacerbated by the small group size and known to occur in tissues such as the genital tract, which undergo cyclic changes. Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus. Ref.: 8 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Salmonella typhimurium Reverse Mutation Assay Guideline : / Substance : Questamide H sample no S1999201, purity > 99% Test fo","page":11,"pdf":"sccp_o_021.pdf","row_type":"noael_study","study_id":"sccp_o_021_noael_001"}
SCCS Opinion NOAEL =15 mg/kg/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 8 3","dose":"Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus.","effect":"male animal were considered to be consistent with this microscopic finding. Genital tract and liver changes similar to those seen after treatment with bishydroxyethyl biscetyl malonamide can occur in control animals. It was considered to be possible that a chance imbalanced incidence of these background findings resulted in an apparently treatment-related distribution, a problem exacerbated by the small group size and known to occur in tissues such as the genital tract, which undergo cyclic changes. Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus. Ref.: 8 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Salmonella typhimurium Reverse Mutation Assay Guideline : / Substance : Questamide H sample no S1999201, purity > 99% Test fo","page":11,"pdf":"sccp_o_021.pdf","row_type":"noael_study","study_id":"sccp_o_021_noael_001"}
Regulatory source 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source repeated dose toxicity 15 mg/kg/day - oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_021; REPORT_TITLE=Opinion on Bishydroxyethyl Biscetyl Malonamide (Questamide H); OPINION_NUMBER=SCCP/0852/04; COMMITTEE=SCCP; REPORT_DATE=7 December 2004; VALUE_TEXT=15; DOSE=Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus.; EFFECT=male animal were considered to be consistent with this microscopic finding. Genital tract and liver changes similar to those seen after treatment with bishydroxyethyl biscetyl malonamide can occur in control animals. It was considered to be possible that a chance imbalanced incidence of these background findings resulted in an apparently treatment-related distribution, a problem exacerbated by the small group size and known to occur in tissues such as the genital tract, which undergo cyclic changes. Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus. Ref.: 8 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Salmonella typhimurium Reverse Mutation Assay Guideline : / Substance : Questamide H sample no S1999201, purity > 99% Test fo; CITATION=Ref.: 8 3; CITATION_NUMBERS=[8,3]; REFERENCE=Ref.: 8 3; DETAILS_JSON={"cas_number":"149591-38-8","citation":"Ref.: 8 3","dose":"Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus.","duration":"Sub-chronic","effect":"male animal were considered to be consistent with this microscopic finding. Genital tract and liver changes similar to those seen after treatment with bishydroxyethyl biscetyl malonamide can occur in control animals. It was considered to be possible that a chance imbalanced incidence of these background findings resulted in an apparently treatment-related distribution, a problem exacerbated by the small group size and known to occur in tissues such as the genital tract, which undergo cyclic changes. Results The NOEL for the notified chemical was judged to be 15 mg/kg/day with target organs being the ovary, uterus, liver and mesenteric lymph node; effects at 150 mg/kg/day were limited to the ovary and uterus. Ref.: 8 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity No data submitted. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity Salmonella typhimurium Reverse Mutation Assay Guideline : / Substance : Questamide H sample no S1999201, purity > 99% Test fo","endpoint":"repeated dose toxicity","ingredient":"Bishydroxyethyl biscetyl malonamide","loael_value":"","noael_unit":"mg/kg/day","noael_value":"15","page":11,"route":"oral","species":"","study_id":"sccp_o_021_noael_001"}
Regulatory source repeated dose toxicity 15 mg/kg/day rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_021; REPORT_TITLE=Opinion on Bishydroxyethyl Biscetyl Malonamide (Questamide H); OPINION_NUMBER=SCCP/0852/04; COMMITTEE=SCCP; REPORT_DATE=7 December 2004; VALUE_TEXT=15; DOSE=A 28-day oral (gavage) repeated dose study with bishydroxyethyl biscetyl malonamide revealed that target organs were the ovary, uterus, liver and mesenteric lymph node.; EFFECT=SCCP/0852/04 Opinion on bishydroxyethyl biscetyl malonamide (Questamide H) 20 skin sensitiser in guinea pigs. In an eye irritation study in rabbits, bishydroxyethyl biscetyl malonamide was moderately irritating, with iris effects observed in all animals and the substance is labeled “Irritating to eyes” in EU. A 28-day oral (gavage) repeated dose study with bishydroxyethyl biscetyl malonamide revealed that target organs were the ovary, uterus, liver and mesenteric lymph node. The NOAEL was 15 mg/kg/day, based on fluid distension of the uterus and microscopic changes in the ovaries and uterus at the 150 and 1000 mg/kg/d. It was estimated that 2 – 3% was absorbed from the gastrointestinal tract. Bishydroxyethyl biscetyl malonamide was shown to be absorbed slowly across human, rat and pig skin. In human skin, penetration was shown to be a maximum of 0.04% of the absorbed dose. Following deposition of bishydroxyethyl biscetyl malonamide on skin in a rinse-off cosmetic product, low levels remained b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149591-38-8","citation":"","dose":"A 28-day oral (gavage) repeated dose study with bishydroxyethyl biscetyl malonamide revealed that target organs were the ovary, uterus, liver and mesenteric lymph node.","duration":"28-day","effect":"SCCP/0852/04 Opinion on bishydroxyethyl biscetyl malonamide (Questamide H) 20 skin sensitiser in guinea pigs. In an eye irritation study in rabbits, bishydroxyethyl biscetyl malonamide was moderately irritating, with iris effects observed in all animals and the substance is labeled “Irritating to eyes” in EU. A 28-day oral (gavage) repeated dose study with bishydroxyethyl biscetyl malonamide revealed that target organs were the ovary, uterus, liver and mesenteric lymph node. The NOAEL was 15 mg/kg/day, based on fluid distension of the uterus and microscopic changes in the ovaries and uterus at the 150 and 1000 mg/kg/d. It was estimated that 2 – 3% was absorbed from the gastrointestinal tract. Bishydroxyethyl biscetyl malonamide was shown to be absorbed slowly across human, rat and pig skin. In human skin, penetration was shown to be a maximum of 0.04% of the absorbed dose. Following deposition of bishydroxyethyl biscetyl malonamide on skin in a rinse-off cosmetic product, low levels remained b","endpoint":"repeated dose toxicity","ingredient":"Bishydroxyethyl biscetyl malonamide","loael_value":"","noael_unit":"mg/kg/day","noael_value":"15","page":20,"route":"oral","species":"rat","study_id":"sccp_o_021_noael_002"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 913CU8H33E UNII - - - chemical {"approval_status":null,"molecular_formula":"C39H78N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"913CU8H33E"}
openFDA substances FDA UNII substance identifier 913CU8H33E UNII - - - chemical {"approval_status":null,"molecular_formula":"C39H78N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"913CU8H33E"}
openFDA substances FDA UNII substance identifier 913CU8H33E UNII - - - chemical {"approval_status":null,"molecular_formula":"C39H78N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"913CU8H33E"}
openFDA substances FDA UNII substance identifier 913CU8H33E UNII - - - chemical {"approval_status":null,"molecular_formula":"C39H78N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"913CU8H33E"}