Registration Dossier
Registration Dossier
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EC number: 222-981-6 | CAS number: 3687-46-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 972 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).
Though the carbon chain length of the alcoholic component is shorter for methyl laurate (one carbon atom) than for the substances within the LCAE category (ten to eighteen carbon atoms), methyl laurate is considered to represent a suitable read across substance for the following reasons: As the toxic effects of primary aliphatic alcohols in general increase with decreasing carbon chain length, methanol is considered to represent the most critical metabolite of the alcoholic component which can result from hydrolysis of a fatty acid ester.
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.
There were no effects of the test substance on the estrous cycle, copulation index, fertility index, gestation length, number of corpora lutea or implantations, implantation index, delivery index or parturition.
The NO(A)ELs for reproductive performance of males and females, as well as pup development are considered to be 1000 mg/kg/day in each case.
Based on the molecular weight ratio this refers to an equimolar NAEL for 9-Octadecenoic acid (9Z)-, decyl ester of 1972.19 mg/kg bw/d.
MW of 9-Octadecenoic acid (9Z)-, decyl ester: 422.74
MW of methyl laurate: 214.35
molar ratio factor = (422.74/214.35) = 1.97
Short description of key information:
OECD 422, rat: NAEL (fertility F0) = 1972 mg/kg bw/d (RA-S CAS No. 111-82-0)
Effects on developmental toxicity
Description of key information
OECD 422, rat: NAEL (pup development F1) = 1972 mg/kg bw/d (RA-S CAS No. 111-82-0)
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 972 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.
No effects attributable to the test substance were revealed in terms of the number of pups born, numbers of live pups on Days 0 or 4 of lactation, number of dead pups, live birth index, sex ratio, viability index and body weights of live pups of both sexes in any treated group.
The NO(A)ELs for reproductive performance of males and females, as well as pup development are considered to be 1000 mg/kg/day in each case.
Based on the molecular weight ratio this refers to an equimolar NAEL for9-Octadecenoic acid (9Z)-, decyl ester of 1972.19 mg/kg bw/d.
MW of9-Octadecenoic acid (9Z)-, decyl ester: 422.74
MW of methyl laurate: 214.35
molar ratio factor = (422.74/214.35) = 1.97
Justification for classification or non-classification
According to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for reproductive toxicity, no classification is required.
Additional information
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