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

Endpoint summary

Description of key information

The acute lethality of the test article was evaluated in two acute studies and a repeated dose study. The results of the studies are:

The acute inhalation LC50 when tested according to OECD 403: > 5.4 mg/L (aerosol)

The acute dermal LD50 when tested according to OECD 402: > 5,000 mg/kg

The NOAEL in an oral reproductive/developmental screening study (OECD 421) was 700 mg/kg/d. Professional judgment was used to conclude that this substance should not be classified for acute oral lethality.

The acute inhalation lethality potential of the test article was evaluated in male and female Sprague Dawley rats. The study was conducted according to OECD 403 (2009) in compliance with OECD GLP regulations. Rats (5/sex) were nose-only exposed 5.4 mg/L of an aerosol of the test article for 4 -hours. Mortality, clinical observations, body weights, and body weight changes were evaluated over a 14-day post-exposure observation period. Necropsies were conducted on all animals. Total mortality was 1/10 animals (1 female mortality) with all animals losing weight from Day 0 to Day1. Two males and 3 females lost 2 to 44 grams from Day 3 to Day 7. One female was 33 grams less than the initial (Day 0) body weight by Day 14. All other surviving animals surpassed their initial body weight by Day 14. No other clinical signs of toxicity were observed. Based on the results of the study, the LC50 of the test article is greater than 5.4 mg/L (aerosol).

The acute dermal lethality of the test article was evaluated in male and female Sprague Dawley rats. The study was conducted according to OECD 402 (1987) in compliance with OECD GLP regulations. The test article (5,000 mg/kg body weight) was administered once dermally under semi-occlusive dressing for 24 hours to clipped, unabraded dorsal skin of 5 male and 5 female rats. Mortality, clinical observations, dermal findings, and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy. There were no deaths, remarkable body weight changes, or test substance-related clinical findings or gross necropsy findings. Based on the results of the study, the dermal LD50 of the test article is greater than 5,000 mg/kg body weight.

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. 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 results of the studies, the test article is not classified for acute lethality via inhalation, dermal exposure or ingestion.