Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

A reproductive/developmental screening study was conducted with the test substance via oral gavage. The result of the study was:

OECD 421 (Oral): NOAEL = 700 mg/kg/day

The objective of this study was to provide data on the potential effects of MTDID 44430 on reproductive performance, pup development, and general toxicity of rats by oral exposure. The study was conducted according to OECD 421 under OECD GLP conditions.  Four groups of rats (n= 10/sex) received 0 (control), 40, 150, and 700 mg/kg MTDID 44430 in corn oil as a single daily oral gavage dose. Males were dosed for 14 days prior to mating and continuing through mating, for a minimum of 28 days, until 1 day prior to euthanasia. Females were dosed for 14 days prior to mating and continuing through lactations Day 12. All animals were dosed at approximately the same time each day. The following parameters and endpoints were evaluated in this study: clinical signs, body weights, food consumption, estrous cycles, reproductive performance, parturition, litter viability and survival, anogenital distance, areolae/nipple anlagen, thyroid hormones, gross necropsy findings, organ weights, and histopathology. At necropsy, the adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries (with oviducts), pituitary gland, prostate gland, seminal vesicle (with coagulating gland and fluid), spleen, testes, thymus gland, and thyroid were weighed. Tissue samples of the brain, coagulating gland, kidneys, liver, mammary glands, ovaries with oviducts, pituitary gland, prostate gland, seminal vesicles (2), testes with epididymides (2), vas deferens, thyroid with parathydroids (2), uterus with cervix and vagina, and gross lesions were collected at necropsy from all animals. Histopathological examination was performed on the tissue samples collected (except the liver, kidney, and thyroid) from animals in the control and high-dose groups and gross lesions were examined from all groups. 1 pup/sex/litter was subjected to a complete necropsy examination, with emphasis on developmental morphology and organs of the reproductive system. RESULTS: All F0 animals survived to the scheduled necropsy. No test substance-related clinical findings were noted. There were no statistically significant changes in mean body weight, mean food consumption, reproductive performance, parturition, thyroid hormones, anogenital distance, areolate/nipple anlagen, litter viability and survival. There were no test substance-related changes in organ weight, gross pathology, and histopathology. No internal findings were noted at the necropsy of euthanized pups. Under the conditions of this study, due to the absence of adverse effects at any dosage level, a dosage level of 700 mg/kg/day was considered to be the no-observed-adverse-effect level (NOAEL) for F0 systemic toxicity, F0 reproductive toxicity, and F1 neonatal toxicity of MTDID 44430 when administered orally by oral gavage to rats.

Justification for classification or non-classification

Based on the result of the study, the test substance is not classified for reproductive or developmental toxicity according to GHS.