Registration Dossier
Registration Dossier
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EC number: 287-636-4 | CAS number: 85566-26-3
Endpoint summary
Administrative data
Description of key information
OECD 422, rat: NOAEL = 1000 mg/kg bw/d of the read across substance methyl laurate.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 740 mg/kg bw/day
Additional information
The read across substance Methyl dodecanoate (CAS# 111 -82 -0) was studied for oral toxicity in rats in an OECD 422 combined repeat dose and reproductive/developmental toxicity screening test (Key JECDB). 12 male and female Crj:CD (SD) rats per dose were administered doses of 0, 250, 500 and 1000 mg/kg/day by gavage. The animals were mated. The test material was administered to females from 14 days before mating until day 3 of lactation and to males for 45 days. Terminal kill was on day 45 for males and on day 4 of lactation for females.
The test substance showed no general toxicological effects in either sex. There were no clinical observations attributable to the administration of test substance and there was no mortality in any of the groups. No effects were observed in terms of body weights, food consumption, hematology, blood chemistry, organ weight, necropsy or histopathological findings.
Therefore, under the experimental conditions of the study the NO(A)EL for methyl dodecanoate for repeated dose toxicity after oral administration is 1000 mg/kg bw/day in both sexes.
Based on the molecular weight ratio this refers to a equimolar NO(A)EL for Fatty acids, C8-10, Me esters of 740 mg/kg bw/d.
Smallest MW of Fatty acids, C8-10, Me esters: 158.2
MW of methyl laurate: 214.35
molar ratio factor = 0.74 (158.2/214.35)
Justification for classification or non-classification
According to DSD (67/548/EEC) or CLP (1272/2008/EC) and based on the available data, the test material does not fulfill the requirements bo be classified for repeated dose toxicity.
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