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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation:

The sensitisation potential of glycerine carbonate was assessed using a method based on the maximisation test described by Magnusson and Kligman (1970). The study involved the treatment of guinea pigs using two procedures: the potential induction of an immune response and a challenge of that response. The sensitisation response of the animals was determined 1 and 2 days after challenge by assessing the degree of erythema.

Challenge of previously-induced guinea pigs with the undiluted test substance elicited a mild sensitisation response.

Challenge of previously-induced guinea pigs with a 75 % w/v preparation of the test substance in deionised water elicited an equal response in test and control animals.

Re-challenge with 50% and 25% w/v preparations of the test substance in deionised water elicited a response which was greater in the control animals than in the test animals. A positive control study using hexylcinnamaldehyde demonstrated the sensitivity of the test system.

Undiluted glycerine carbonate elicited a mild skin response in test animals, however, lower concentrations elicited some irritation in both test and control animals. This inconsistent response renders the result inconclusive. Therefore, this study is assigned as supporting study.

In addition, a Buehler test was performed to determine if glycerine carbonate elicits a delayed dermal contact hypersensitivity response in guinea pigs by the measurement of skin reactivity. Initially, a dose range was performed in four naïve animals with the test article, JEFFSOL GC (Glycerine carbonate), at 10%, 25%, 50% and 100% (as received). Based on these results, an induction dose and challenge dose of 100% (as received) was chosen for this study.

For the induction phase of this study, twenty guinea pigs (10/sex) in the test article group were induced with three six-hour occluded dermal applications of glycerine carbonate as received. A vehicle group of ten animals (5/sex) was induced in the same manner with distilled water. A positive control group of six animals (3/sex) was induced with known dermal sensitizer: 1 -chloro-2,4 -dinitrobenzene (DNCB) (0.3% in 80% Ethanol).

Fifteen days after the last induction, all animals were dermally challenged with occluded applications at naïve test sites. Animals in the test article group were challenged with glycerine carbonate (as received). Animals in the vehicle control group were challenged with glycerine carbonate as received and distilled water. Animals in the positive control group were challenged with DNCB (0.2% in acetone). On the day following the challenge, animals were scored for dermal irritation (24 hour). Scoring was repeated at 48 hours.

Under the conditions of this study, induction with glycerine carbonate as received did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged as received.

This study was assigned as key study.

Migrated from Short description of key information:
Skin sensitisation:
The skin sensitisation potential of glycerine carbonate was evaluated using the Buehler method (study performed according OECD Guideline 406 and US EPA OPPTS 870.2600). Under the conditions of the study, induction with glycerine carbonate as received did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged. This study was assigned as key study.

A Guinea pig maximisation test (GPMT) was performed before the Buehler test, following a method similar to the OECD guideline 406 and EU Method B.6. The result of this test (Johnson 2002) was declared inconclusive. Therefore the study does not allow to conclude on the skin sensitisation potential of the substance and the Buehler test was performed.

Justification for selection of skin sensitisation endpoint:
The Buehler test was considered the most reliable one. The GPMT test gave ambiguous results.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available information of the Buehler test and the criteria of the DSD and CLP Regulation the substance is considered not to be a skin sensitiser.