Registration Dossier

Administrative data

Description of key information

The test substance is not irritating to the skin (OECD TG 404, GLP).
The test substance is irritating to the eye (OECD TG 405, GLP).

Key value for chemical safety assessment

Additional information

Skin irritation:

A GLP guideline study (OECD TG 404) study for assessment of skin irritation of Dimethylmalonate is available. Three rabbits (Small white russian, Chbb: HM, SPF) were treated with the undiluted test substance for 4 h under semiocclusive conditions. Slight erythema (grade 1) was observed in all 3 animals 30 to 60 min after removal of the patch. These findings were fully reversible within 24 hours. The mean values (24, 48, and 72h) of erythema and edema were 0 for all animals. Thus, the test substance is not irritating to the skin.

Eye irritation:

A GLP guideline study (OECD TG 405) study for assessment of eye irritation of Dimethylmalonate is available. Three rabbits (Small white russian, Chbb: HM, SPF) were treated with 0.1 mL of the undiluted test substance for 24 h. Then the test substance was washed out. Corneal opacity was observed in all 3 animals (mean score 24, 48, 72 h: 1, 1.33, 1.67), but was fully reversible within 6 days. Iris mean score (24, 48, 72 h) was 1, 0.33, 0.67. Iris score was also fully reversible within 6 days. Conjunctivae mean score (24, 48, 72 h) was 2 for all animals, and was fully reversible within 8 days. Also chemosis scores were fully reversible within 8 days (mean scores 24, 48 , 72 h: 1.33, 1.33, 1.67). Thus, the test substance is irritating to the eye.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

- No classification required for skin and eye irritation.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008 (last amended by EC/286/2008 (2011-03-10)):

- No classification required for skin irritation.

- The test substance is classified as an eye irritant, Cat. 2.