Animal studies with respect to reproductive, developmental or chronic toxicity

However, testing for developmental toxicity must be considered.

The lowest dose level should aim to not produce any evidence of either maternal or developmental toxicity including neurotoxicity.

Developmental toxicity studies shall always be carried out.

Developmental Neurotoxicity and developmental immunotoxicity are regarded as important and relevant developmental toxicity endpoints, which could be further investigated.

Animal studies with respect to reproductive, developmental or chronic toxicity

Developmental toxicity shall be determined for rat and rabbit by the oral route

developmental toxicity screening study in the rat.

These are genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation.

A developmental toxicity test in the rat is required.

These are genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation endpoints.

Maternal toxicity occurred at doses similar to those eliciting developmental toxicity.

Test No. 414: Prenatal development toxicity study.

Developmental toxicity must be determined both to rat and rabbit by the oral route.

A developmental toxicity test in the rat is required.