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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effect on fertility: via oral route
Dose descriptor:
NOAEL
10 mg/kg bw/day
Additional information

No relevant data are available for reproductive performance itself. However, the results of the 28 -day oral toxicity study can be used to set an indicative NOAEL based on the severe morphological changes in the reproductive organs of both sexes. The 10mg/kg NOAEL obtained from the 28-day repeated dose toxicity study is selected for toxicity to reproduction. It unlikely that any further information obtained about the possible toxicity to reproduction (fertility or development) by requiring additional testing would enhance the possible risk reduction measures needed by a genotoxic carcinogen.


Short description of key information:
No specific studies for reproductive toxicity are available for EPTAC. However, the key repeated dose toxicity study in rats via the oral route (see Section 7.5.1) showed serious adverse effects on the reproductive organs of both sexes at dose levels of 31.6 and 100 mg/kg/d. Changes in males were not reversed in a four-week recovery period for the high dose group. The NOAEL for reproductive effects was therefore judged to be 10 mg/kg/day.

Effects on developmental toxicity

Description of key information
No developmental toxicity data are available. 

Justification for classification or non-classification

Additional information