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

Endpoint summary

Description of key information

Skin irritation: Mallory VT (1993) performed a K2 primary dermal irritation study to assess the skin irritation potential of glycerine carbonate in New Zealand White rabbits according to a method equivalent to OECD Guideline 404. Glycerine carbonate was not observed to be irritating to the skin. This study was selected as key study.
Eye irritation:
Based on the data of a study performed similar to OECD Guideline 405 study, glycerine carbonate was shown not to be irritating to the eyes (Mallory VT, 1993).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a primary dermal irritation study in rabbits, glycerine carbonate was applied to five sites on the dorsal trunk of six rabbits (3 males/3 females) at 0.5 mg/site. The exposure periods for the two intact upper dorsal sites were 3 and 60 minutes, respectively. The exposure period for the one intact mid dorsal site was 4 hours. The exposure period for the two lower sites (one intact and one abraded) was 24 hours. All sites were scored immediately and at 21, 48 and 72 hours after unwrapping.

No signs of erythema, edema or necrosis were observed at any observation period at the 3 and 60 minute, 4 and 24 hour (intact and abrased) exposure sites. The study was terminated following the 72 -hour observation period.

The test article was considered to be a non-irritant at both 4 and 24 hour exposure.

Eye irritation

In the key study by Pharmakon Research (1993), 6 rabbits were instilled 0.1 ml of undiluted test substance in one eye, while the other eye served as control. The eyes were examined at 1, 24, 48 and 72 hours after treatment. Positive ocular responses were observed at 1, 24, 48 and 72 hours. A Maximum mean total score (MMTS) of 6.3 was recorded after 1 hour but was fully reversible, and given the low scores regarding the cornea (0 of 4), iris (0 of 4) and conjunctivae (<1 of 3) at the 24,48 and 72 h, no adverse effect on eyes were observed. All ocular scores returned to normal at 72 hours and the study was terminated. Based upon the observations made in the primary eye irritation study, the test article was determined not to be an eye irritant. Hence, according to the criteria of the DSD and CLP Regulation the substance should not be classified as irritating to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation 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 a skin irritant.

According to the results of the eye irritation study and the criteria of the DSD and CLP Regulation, glycerine carbonate should not be classified as an eye irritant.