Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

A study conducted with a TDI polyurea grease thickener is read across to members of the polyurea MDI category.

An oral reproductive toxicity screening study in rats conducted according to OECD 422 concluded that no adverse effect was seen in any of the reproductive parameters examined at any dose.


Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A study conducted with a TDI polyurea grease thickener is read across to members of the polyurea MDI category.

A key subacute toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on Diurea 8 in a base grease via daily oral gavage administration in MOL WO M 46 Medicinal white oil. Diurea 8 was administered at dose levels of 0, 375, 750 and 1500 mg/kg bw/day nominal, equating to 64.8, 130 and 259 mg/kg bw/day Active Ingredient. There were no treatment-related effects at any dose level on any of the reproductive parameters evaluated in this study, or in any of the developmental parameters evaluated. Based on these data, the NOAEL for reproductive and developmental toxicity was 1500 mg/kg bw/day, equivalent to 259 mg/kg bw/day Active Ingredient.

Effects on developmental toxicity

Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

MDI category members are not classified as no adverse reproductive or developmental toxicity effects observed in the study conducted with the structural analogue substance.