NOAEL Studies Cosmetic Ingredient

Stearalkonium Bentonite NOAEL Studies

INCI: STEARALKONIUM BENTONITE

CAS: 130501-87-0

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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CIR Safety Assessment 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =1000 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"1; 10; 28","dose":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified.","effect":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified. Repeated Dose Toxicity Dermal Data on the repeated dose dermal toxicity of the alkonium clays in this safety assessment were not found in the published literature and no unpublished data were provided. Oral – Non-Human STEARALKONIUM BENTONITE In a 28-day oral toxicity test of stearalkonium bentonite (100, 316, and 1000 mg/kg in 0.1% aqueous solution of Na-carboxymethylcellulose) in Fischer CDF(F344)/CRLBR, SPF rats (n=5/sex), the no-observed-effect-level (NOEL) was 1000 mg/kg/d when administered by gavage, based on the absence of test substance-related toxicological effects at any of the doses administered.25 The test was conducted according to OECD TG 407. Clinical signs were similar in the treatment and control groups. Chromodakryorrhoea was observed occasionally in both the control and treatment groups. There were no differences in feed consumption or body weight gain in males. Decreased body weights were recorded for females in the high dose recovery group (duration of recovery period not specif...","page":6,"pdf":"FR698.pdf","row_type":"noael_study","study_id":"FR698_noael_001"}
CIR Safety Assessment NOAEL =1000 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"1; 10; 28","dose":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified.","effect":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified. Repeated Dose Toxicity Dermal Data on the repeated dose dermal toxicity of the alkonium clays in this safety assessment were not found in the published literature and no unpublished data were provided. Oral – Non-Human STEARALKONIUM BENTONITE In a 28-day oral toxicity test of stearalkonium bentonite (100, 316, and 1000 mg/kg in 0.1% aqueous solution of Na-carboxymethylcellulose) in Fischer CDF(F344)/CRLBR, SPF rats (n=5/sex), the no-observed-effect-level (NOEL) was 1000 mg/kg/d when administered by gavage, based on the absence of test substance-related toxicological effects at any of the doses administered.25 The test was conducted according to OECD TG 407. Clinical signs were similar in the treatment and control groups. Chromodakryorrhoea was observed occasionally in both the control and treatment groups. There were no differences in feed consumption or body weight gain in males. Decreased body weights were recorded for females in the high dose recovery group (duration of recovery period not specif...","page":6,"pdf":"FR698.pdf","row_type":"noael_study","study_id":"FR698_noael_001"}
CIR Safety Assessment NOAEL =1000 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"1; 10; 28","dose":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified.","effect":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified. Repeated Dose Toxicity Dermal Data on the repeated dose dermal toxicity of the alkonium clays in this safety assessment were not found in the published literature and no unpublished data were provided. Oral – Non-Human STEARALKONIUM BENTONITE In a 28-day oral toxicity test of stearalkonium bentonite (100, 316, and 1000 mg/kg in 0.1% aqueous solution of Na-carboxymethylcellulose) in Fischer CDF(F344)/CRLBR, SPF rats (n=5/sex), the no-observed-effect-level (NOEL) was 1000 mg/kg/d when administered by gavage, based on the absence of test substance-related toxicological effects at any of the doses administered.25 The test was conducted according to OECD TG 407. Clinical signs were similar in the treatment and control groups. Chromodakryorrhoea was observed occasionally in both the control and treatment groups. There were no differences in feed consumption or body weight gain in males. Decreased body weights were recorded for females in the high dose recovery group (duration of recovery period not specif...","page":6,"pdf":"FR698.pdf","row_type":"noael_study","study_id":"FR698_noael_001"}
CIR Safety Assessment NOAEL =1000 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"1; 10; 28","dose":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified.","effect":"ey rats (n not specified) were exposed for 1 h.10 Particle size was not specified. Repeated Dose Toxicity Dermal Data on the repeated dose dermal toxicity of the alkonium clays in this safety assessment were not found in the published literature and no unpublished data were provided. Oral – Non-Human STEARALKONIUM BENTONITE In a 28-day oral toxicity test of stearalkonium bentonite (100, 316, and 1000 mg/kg in 0.1% aqueous solution of Na-carboxymethylcellulose) in Fischer CDF(F344)/CRLBR, SPF rats (n=5/sex), the no-observed-effect-level (NOEL) was 1000 mg/kg/d when administered by gavage, based on the absence of test substance-related toxicological effects at any of the doses administered.25 The test was conducted according to OECD TG 407. Clinical signs were similar in the treatment and control groups. Chromodakryorrhoea was observed occasionally in both the control and treatment groups. There were no differences in feed consumption or body weight gain in males. Decreased body weights were recorded for females in the high dose recovery group (duration of recovery period not specif...","page":6,"pdf":"FR698.pdf","row_type":"noael_study","study_id":"FR698_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier AH5EVE6GTY UNII - - - chemical {"approval_status":null,"molecular_formula":"C27H50N.2Al.Cl.3O.4O2Si.H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AH5EVE6GTY"}
openFDA substances FDA UNII substance identifier AH5EVE6GTY UNII - - - chemical {"approval_status":null,"molecular_formula":"C27H50N.2Al.Cl.3O.4O2Si.H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AH5EVE6GTY"}
openFDA substances FDA UNII substance identifier AH5EVE6GTY UNII - - - chemical {"approval_status":null,"molecular_formula":"C27H50N.2Al.Cl.3O.4O2Si.H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AH5EVE6GTY"}
openFDA substances FDA UNII substance identifier AH5EVE6GTY UNII - - - chemical {"approval_status":null,"molecular_formula":"C27H50N.2Al.Cl.3O.4O2Si.H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AH5EVE6GTY"}