1-(2-hydroxyethyl)imidazolidin-2-one

Endpoint summary

Description of key information

1-(2-hydroxyethyl) imidazolidin-2-one is not irritating to the skin of rabbits and considered not irritating to the rabbit eye. There are no data available concerning respiratory irritation.

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)

Additional information

The primary skin irritation of 1-(2-hydroxyethyl) imidazolidin-2-one was tested in White Vienna rabbits in an OECD guideline 404 study (BASF AG, 1988).The substance (0.5 ml, undiluted) was applied to the skin for 4 hours (3 animals) under semi-occlusive conditions. Animals were observed at 1, 24, 48 and 72 hours after removal of the substance.

One hour after removal of the substance very slight erythema (score 1) was observed in all animals, which was no longer visible in two animals at 24 hours after exposure and in one animal 48 hours after exposure. The mean (24, 48, 72 hours) erythema and edema score were both 0. The substance was judged to be not irritating to the skin.

 

In a second GLP compliant OECD guideline 404 study, three rabbits were exposed to 0.5 ml of undiluted 1-(2-hydroxyethyl) imidazolidin-2-one, applied onto shaved skin for 4 hours using a semi-occlusive dressing (Akzo Nobel/NOTOX, 1995). Observations were made 1, 24, 48 and 72 hours after exposure. Exposure to 1-(2-hydroxyethyl) imidazolidin-2-one resulted in very slight erythema in the treated skin-areas of the rabbits, which had resolved within 24 hours. No signs of systemic intoxication were observed during the study period. The mean (24, 48, 72 hours) erythema and edema score were both 0. The substance was judged to be not irritating to the skin.

The ocular irritancy of 1-(2-hydroxyethyl) imidazolidin-2-one was tested in the rabbit eye in a study according to OECD guideline 405 (BASF AG, 1988).

0.1 ml of the test substance was instilled in the lower conjunctival sac of 3 Whiterabbits (no washing was performed). Animals were observed 1, 24, 48 and 72 hours after test item instillation. Chemosis (score 1) was observed in two animals 1 hour after application. Conjunctivae discharge (score 2) was observed in all animals 1 after application. The mean (24, 48, 72 hours) cornea, iris and chemosis score were all 0. Regarding the conjunctivae score, the mean (24, 48, 72 hours) score was 0.9 (the effect was fully reversible within 72 hours). The substance was judged to be not irritating to the eyes.

 

In a second OECD guideline 405 study, single samples of 0.1 ml of 1-(2-hydroxyethyl) imidazolidin-2-one were instilled into one eye of each of three New Zealand White rabbits (Akzo Nobel/NOTOX, 1995, GLP compliant). Observations were made 1, 24, 48 and 72 hours and 7 days after instillation.

Instillation of the substance into one eye of each of the animals resulted in effects on the conjunctivae. The irritation of the conjunctivae consisted of redness, chemosis and discharge, which had resolved within 7 days after instillation. Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals. The mean (24, 48, 72 hours) cornea and iris score were both 0. Regarding the conjunctivae score, the mean (24, 48, 72 hours) score was 1.1 (the effect was fully reversible within 7 days). Regarding the chemosis score, the mean (24, 48, 72 hours) score was 0.3 (the effect was fully reversible within 7 days). The substance was judged to be not irritating to the eyes.

 

Justification for classification or non-classification

Based on the available data, the substance does need not to be classified for skin and eye irritation according to Directive 67/548/EEC and according EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.