Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 130 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.

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 a equimolar NO(A)EL for methyl myristate of 1130 mg/kg bw/d.

MW of methyl myristate: 242.4

MW of methyl laurate: 214.35

molar ratio factor = 1.13 (242.4/214.35)


Short description of key information:
OECD 422, rat: NOAEL (fertility F0) = 1000 mg/kg bw/d of the read across substance methyl laurate (CAS No. 111-82-0).

Effects on developmental toxicity

Description of key information
OECD 422, rat: NOAEL (pup development F1) = 1000 mg/kg bw/d of the read across substance methyl laurate (CAS No. 111-82-0).
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 130 mg/kg bw/day
Additional information

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 a equimolar NO(A)EL for methyl myristate of 1130 mg/kg bw/d.

MW of methyl myristate: 242.4

MW of methyl laurate: 214.35

molar ratio factor = 1.13 (242.4/214.35)

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 reproductive/developmental toxicity.