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Description of key information

Acute oral toxicity: The LD50 after oral application to male rats is 1,030 mg/kg bw and the kidney is the potential target organ. Acute inhalation toxicity: The LC 50 after inhalation was determined in male rats (LC50 1.07-5.01 mg/l) and in female rats (LC 50 > 5.01 mg/l) resulting in a LC50 of >5.01 mg/l for both sexes. Acute dermal toxicity: The LD 50 after dermal exposure is > 2000 mg/kg bw in  rats.

Key value for chemical safety assessment

Additional information

Studies in animals:

Oral acute toxicity

Cited from SIAR for SIAM 18 (Paris, April 2004):

"The oral LD50in male Sprague-Dawley rats was determined to be 1,030 mg/kg b.w. (Klimmer,

1965). Doses of 0.5, 1.0, 1.5, 2.0, or 2.5 ml/kg bw of a 50 % v/v solution in water were applied by

gavage followed by a post dose observation period of 14 days. Clinical signs observed from 1 hour

after dosing were restlessness, thirst, rough fur and tiredness. At necropsy, irritation of the intestinal

mucosa was observed. A few animals (no further data) showed a slight increase in kidney weight

and protein in the urine, which may indicate that the kidney is a target organ."

Acute inhalation toxicity

A study was conducted to determine the acute toxicity of Isophorone diamine in rats following a single 4 hour inhalation exposure. Surviving animals were retained for a 14 day post exposure observation period. Three groups of rats (5male and 5 female per group) were exposed to 0.5, 1.0 and 5.0 mg/L areosol of Isophorone diamine once for 4 hours.

In conclusion, the 4 hour inhalation exposure to a mist (aerosol) of Isophorone diamine at 5.01 mg/L, resulted in respiratory difficulties for all animals with the death of one male during exposure and 2 males during the post dose observation period. For males the LC50 is estimated to be between 1.07 and 5.01 mg/L and for the females the LC50 could not be established but was considered to be in excess of 5.01 mg/L. The overall LC50 (for the sexes combined) could also not be established but was considered to be in excess of 5.01 mg/L.

Acute dermal toxicity

A study was conducted to assess the potential toxicity of the test substance isophorone diamine, following a single dermal treatment to Sprague-Dawley rats.

All animals at 2,000 mg/kg treatment survived the duration of the study.

Discoloration of skin and crust formation from Days 1 to 14 after dosing and scar from Days 11 to 14 were observed on the treated sites of all animals at 2,000 mg/kg treatment. These were considered to be test substance-related effects. No test substance-realted affected on body weights were observed.

In necropsy findings, crust was observed on the treated sites of all animals at 2,000 mg/kg treatment. In histopatholocical findings, scar as mild to moderate was observed on the treated sites of all animals. These were considered to be skin wounds caused by the test substance.

Based on the results of this study, Acute toxicity of isophorone diamine, the dermal LD50 was > 2,000 mg/kg in male and female rats.

Justification for classification or non-classification

Because of acute oral toxicity the substance isophorone diamine is classified as Xn (R22; Harmful if swallowed) according 67/548/EEC and Category 4, (H302: Harmful if swallowed)according CLP regulation (1272/2008, self classification).