Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
OECD Guideline, GLP study
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In an OECD 422, 28-day and 1-generation oral gavage screening study in rats there were no test substance-related effects on reproductive performance or effects on offspring at any concentration tested. Under the conditions of this study, the test substance was not a selective reproductive toxicant. The NOAEL for reproductive toxicity and effects on offspring was 200 mg/kg/day, the highest concentration tested.


Short description of key information:
Oral: OECD 407 and OECD 422; 28-day and 1-Gen Screen gavage, rats. NOAEL (reproductive effects) = 200 mg/kg (highest dose tested). Reliability = 1

Justification for selection of Effect on fertility via oral route:
OECD Guideline, GLP study

Effects on developmental toxicity

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

The test substance did not adversely affect reproductive function. The substance does not need to be classified for reproductive toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.