Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

In accordance with column 2 of REACH Annex IX, reproductive toxicity testing does not need to be conducted as the substance is known to be a genotoxic carcinogen.


Short description of key information:
Reproductive toxicity testing does not need to be conducted as the substance is known to be a genotoxic carcinogen.

Effects on developmental toxicity

Description of key information
Based upon the findings in a developmental/teratogenicity study in rats, ethylenimine did not show teratogenic properties.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1.03 mg/kg bw/day
Additional information

In a teratogenicity study, 1.24 or 3.1 µL/kg bw (corresponding to approx. 1.03 and 2.57 mg/kg bw) of the test substance were given to rats (17-34 rats per group) by gavage on days 6 to 15 of pregnancy (BASF, 1975). For each concentration one group of rats was left untreated as control. On day 20 post coitum all females were sacrificed. 847 living fetuses were isolated and examined.

 

A dose of 2.57 mg/kg bw had a toxic effect on the rats and consequently an embryolethal and fetotoxic effect. The developmental toxic effects were also due to the toxic effect on the pregnant rats. A dose of 1.03 mg/kg bw of the test substance did not cause any clinical symptoms. No embryolethal, fetotoxic or teratogenic effects were observed at this dose level.

Justification for classification or non-classification

According to Annex I of Directive 67/548/EEC, classificationfor reproductive toxicity is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.