Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

In a reproductive and developmental toxicity screening study (OECD 421) the substance was administered to rats (12/sex/dose) by oral gavage at dose levels of 0, 30, 300 or 1000 mg/kg bw/day. No adverse effects were reported on reproductive parameters and the NOEL is 1000 mg/kg bw/day, this being the highest dose tested.

There are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity. Therefore the conduct of an EOGRTS is not justified.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Sufficient to address requirements.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

In a reproductive and developmental toxicity screening study (OECD 421) the substance was administered to rats (12/sex/dose) by oral gavage at dose levels of 0, 30, 300 or 1000 mg/kg bw/day. No adverse effects were reported on developmental parameters and the NOEL is 1000 mg/kg bw/day, this being the highest dose tested. Since the supply volume has now exceeded 100tpa, a testing proposal has been submitted to ECHA for a new developmental toxicity study in the rat (OECD 414).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Sufficient to address requirements.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings of a reliable reproductive and developmental toxicity screening study (OECD 421), classification of the substance is not justified.