Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Toxicity to soil organisms:

2-Pyrrolidone is not supposed to be directly applied to soil. Furthermore, the test substance is readily biodegradable and hence, in case of indirect exposure of soil, 2-pyrrolidone is expected to rapidly degrade. Therefore soil is not expected to be a compartment of concern. The risk to soil organisms is negligible. Hence the soil toxicity endpoints can be waived.

Toxicity to birds:

In Annex X of the Regulation (EC) No 1907/2006, it is suggested, that in case of long term toxicity testing to birds "any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level." Furthermore, ECHA (2008) states in the "Guidance on information requirements and chemical safety assessment Chapter R.7c" that "given that mammalian toxicity is considered in detail for human health protection, the need for additional data for birds must be considered very carefully – new tests are a last resort in the data collection process." As the substance is not bioaccumulative and because of reasons of animal welfare, no study on toxicity in birds is performed.