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Description of key information

A LD50 value of >5000 mg/kg bw  was observed for rats after acute oral and dermal exposure. There are no data available concerning acute inhalation toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Value:
mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Value:
mg/kg bw

Additional information

In two acute oral toxicity studies performed according to a protocol comparable to OECD guideline 401, 1-(2-hydroxyethyl) imidazolidin-2-one was tested in Wistar rats, 5 males and 5 females, by single oral gavage of 2000 mg/kg bw after which the animals were observed for 14 days (BASF AG, May 1988 and June 1988). In both studies no mortalities, body weight effects or clinical signs of toxicity were observed. Necropsy revealed no gross changes. The acute oral LD50 for 1-(2-hydroxyethyl) imidazolidin-2-one in male and female rats was greater than 2000 mg/kg bw.

 

In another study, the acute oral toxicity of 1-(2-hydroxyethyl) imidazolidin-2-one was assessed in Crl:CD® BR rats in a GLP compliant OECD guideline 401 study (Rohm and Haas, 2002). The test substance was identified as a clear liquid containing 75% active ingredient in water. Five male and five female rats were gavaged once with the undiluted test substance at 5000 mg/kg bw after which the animals were observed for 14 days. There were no mortalities, body weight effects, or clinical signs of toxicity. Necropsy revealed no gross changes. The acute oral LD50 for the substance in male and female rats was greater than 5000 mg/kg bw.

 

In a fourth study, the substance was also administered once by oral gavage to five rats of each sex at 2000 mg/kg bw in a GLP compliant OECD guideline 401 study (Akzo Nobel/NOTOX, 1995). The animals were observed for 14 days.

No mortality occurred. Hunched pasture and/or piloerection were observed in one male and one female on day 1. Body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found in the animals at macroscopic post mortem examination. The oral LD50 value of 1-(2-hydroxyethyl) imidazolidin-2-one in rats was established as exceeding 2000 mg/kg bw.

 

The acute dermal toxicity of the substance was assessed in Crl:CD®BR rats in a GLP compliant OECD guideline 402 study (Rohm and Haas, 2002).The test substance was identified as a clear liquid containing 75% active ingredient in water.The test substance was applied to the shaved intact skin of five male and five female rats at 5000 mg/kg bw. The application sites were occluded for 24 hours. After the 24 hour exposure, the application sites were wiped with paper towels saturated with tap water and blotted dry with paper towels. The animals were observed for 14 days.

There were no mortalities, clinical signs of systemic toxicity, or body weight effects.

No skin irritation effects were observed. Necropsy revealed no gross changes. The acute dermal LD50 for the substance was greater than 5000 mg/kg bw in male and female rats.

Justification for classification or non-classification

Based on the results of the acute oral and dermal toxicity studies, 1-(2-hydroxyethyl) imidazolidin-2-one needs not to be classified according to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

 

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