Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

A screening study is available for the read-across substance.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
A good quality guideline- and GLP-compliant study is available for the read-across substance.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No effects on fertility or reproduction were seen at the highest dose level of 300 mg/kg bw/d with the read-across substance.

Effects on developmental toxicity

Description of key information

A testing proposal is included for the read-across substance, this has alsoready been approved by EFSA.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no 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

Justification for classification or non-classification

No classification for reproductive toxicity is proposed in the absence of any effects on fertility or development in the screening study with the read-across substance.