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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

The oral administration of test material to rats for a period of forty-two days for males and up to fifty-four days for females (including two weeks pre-mating, gestation and early lactation period) at dose levels of up to 1000 mg/kg/day, and no treatment-related effects in the reproductive parameters were observed. All treated and control females showed comparable number of litters at termination on Day 5 postpartum and no treatment-related effects were observed for offspring growth or development. Therefore, a NOEL for reproductive toxicity was considered to be 1000 mg/kg/day.


Short description of key information:
OECD 422:
The test material was orally administered to rats for a period of forty-two days for males and up to fifty-four days for females at dose levels of up to 1000 mg/kg/day. No treatment-related effects in the reproductive parameters were observed, and a NOEL for reproductive toxicity was considered to be 1000 mg/kg/day.

Effects on developmental toxicity

Description of key information
OECD 422:
The test material was orally administered to rats for a period of forty-two days for males and up to fifty-four days for females at dose levels of up to 1000 mg/kg/day. No treatment-related effects in the reproductive parameters were observed, and a NOEL for reproductive/developmental toxicity was considered to be 1000 mg/kg/day.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

The oral administration of test material to rats for a period of forty-two days for males and up to fifty-four days for females (including two weeks pre-mating, gestation and early lactation period) at dose levels of up to 1000 mg/kg/day, and no treatment-related effects in the reproductive/developmental parameters were observed. All treated and control females showed comparable number of litters at termination on Day 5postpartumand no treatment-related effects were observed for offspring growth or development. Therefore, a NOEL for reproductive/developmental toxicity was considered to be 1000 mg/kg/day..

Justification for classification or non-classification

There are conclusive and sufficient data for classification of the registered substance with regard to reproduction toxicity.

This substance is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008.

Additional information