4-hydroxymethyl-1,3-dioxolan-2-one

Endpoint summary

Description of key information

Acute toxicity: oral:
A K2 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Mallory VT, 1993). 
Acute toxicity: inhalation
A K1 acute inhalation toxicity test was performed in male and female Sprague Dawley rats according to OECD Guideline 403 and US EPA OPPTS Guideline 870.1300 (Weinberg, 2014). 
Acute toxicity: dermal
A K2 acute dermal toxicity test was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402 (Mallory VT, 1993).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity: In a dose-range-finding study, the test article was orally administrated to three groups of two rats (one male and one female per group) at dose levels of 500, 2500 and 5000 mg/kg (Mallory VT, 1993). No clinical signs were observed in any animals during the study. None of the animals died at the 500, 2500 or 5000 mg/kg dose levels. Based upon these results, a limit test was performed.

In a limit test, the test article was orally administrated to one group of ten rats (five males and five females), at a dose level of 5000 mg/kg. No clinical signs were observed in any animal during the study. There was an apparent increase in body weight for all animals during the study. None of the animals died at the 5000 mg/kg dose level. No visible lesions were observed in any of the animals at terminal necroscopy.

Based on the results from the acute oral toxicity study in rats, the estimated acute oral LD50 (combined sexes) for glycerine carbonate was determined to be greater than 5000 mg/kg.

Acute inhalation toxicity: The acute inhalation toxicity of glycerine carbonate was evaluated in a 4 -hour, single-exposure study in rats (Weinberg, 2014). A range-finding exposure was conducted using 1 rat/sex at a concentration of 5.4 mg/L to determine tolerability prior to the definitive exposure. For the definitive study, the test substance was administered to 1 group of 5 male and 5 female rats via nose-only inhalation exposure as a liquid droplet aerosol at a concentration of 5.6 mg/L. The aerosol exposure atmosphere was characterized by a mean particle size of 2.4 ± 1.92 µm (MMAD ± GSD).

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.

Mortality for the range finding exposure was 0/2 animals. Mortality for the 56 mg/L definitive exposure was 0/10 animals. There were no significant clinical observations noted immediately following exposure or at the 1 -2 hour post-exposure observation period for any animal. During the 14 -day post-exposure observation period, dried red material on the dorsal neck was observed for 2 females and swollen facial area was observed for 1 male. All animals were considered clinically normal by study day 2. Four males and 2 females in the 5.6 mg/L group lost weight from study day 0 to 1. All animals surpassed their initial body weight by study day 14. The only macroscopic finding noted at the scheduled necropsy was clear fluid contents in the uterus for 1 female.

Based on the results of this study, the LC50 of glycerine carbonate was > 5.6 mg/L when male and female rats were exposed to an aerosol of the substance as a single 4 -hour, nose only exposure.

Acute dermal toxicity: In a dermal limit test, one group of ten rabbits (5 males/5 females) was exposed to glycerine carbonate, directly applied onto the exposed skin at 3000 mg/kg (Mallory VT, 1993). No clinical signs were observed in any animal at any observation period. There was an apparent increase in mean body weight during the study. None of the animals died during the study. No visible lesions were observed in any animals at terminal necroscopy.

Based on the observations made in the acute exposure dermal toxicity study in rabbits, the estimated acute dermal LD50 (combined sexes) for glycerine carbonate was determined to be greater than 3000 mg/kg.

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – inhalation endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Based on the available data and the criteria of the DSD and CLP Regulation, glycerine carbonate should not be classified as acute toxic via the oral, dermal or inhalation route.