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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

In the key study (BASF AG, 2009); the fertility parameters measured in the 90-days repeated dose study were used to assess the reproduction toxicity of the test substance. The substance was administered to groups of 10 male and 10 female Wistar rats at concentrations in the diet of 0 (vehicle control), 250 and 1250 ppm in animals of either sex as well as at concentrations of 5000 ppm in males and 2500 ppm in females over a period of 3 months. Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. Vaginal smears for cycle determination were prepared from day 60 to the end of the administration period. Sperm analyses were performed towards the end of the administration period. Signs of general toxicity were observed only in male animals of the 5000 ppm group as indicated by a reduced body weight and body weight gain. There were no treatment-related changes in the sperm or estrus cycle parameters measured. Thus, no observed adverse effects levels (NOAEL) on the fertility parameters in both males and females were considered to be 326.3 and 191.3 mg/kg bw/d, respectively. 


Short description of key information:
Based on the results, the test substance does not need any classification for toxicity to reproduction (fertility) according to EU and GHS standards. No study is available for developmental toxicity.

Effects on developmental toxicity

Additional information

No study available.

Justification for classification or non-classification

Additional information