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Key value for chemical safety assessment

Effects on fertility

Description of key information

Based on the findings in the screening study a study on developmental toxicity according OECD 414 is proposed.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
60 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One screening study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Short description of key information:
The parental NOAEL of reproductive toxicity was considered to be 60 mg/kg/day for male and female rats. No higher doses were tested.

Justification for selection of Effect on fertility via oral route:
Only one study available

Effects on developmental toxicity

Description of key information
The parental NOAEL of reproductive toxicity was considered to be 60 mg/kg/day for male and female rats. No higher doses were tested
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
60 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
one screening study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available

Justification for classification or non-classification

The presented data for toxicity to reproduction is reliable and an adequate guideline study. The observations within the study are conclusive but not sufficient for a classification according to Regulation (EC) No. 1272/2008.

Additional information