Registration Dossier

Ecotoxicological information

Toxicity to birds

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to birds: reproduction test
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

Key value for chemical safety assessment

Additional information

Information about toxicity to birds is not required under Regulation (EC) No 1907/2006 within this tonnage band but to complete the data set additional information are provided.

 

According to chapter R16 of the Guidance on information requirements and chemical safety assessment published by ECHA (2016), a substance can be assessed in a first step based on classification on the basis of mammalian toxicity data whether it has a potential to cause toxic effects if accumulated in higher organisms. For substances that are classified as Very Toxic (T+) or Toxic (T) or harmful (Xn) with at least one of the risk phrases R48, R60, R61, R62, R63 or R64, secondary poisoning is a relevant route of exposure. As the substance is not classified as toxic or harmful, the substance is not considered to cause toxic effects in predators. Additionally, the predicted log Kow (< 3) indicates only low potential for bioaccumulation. In conclusion, the substance is considered to cause low hazard to predators. Thus, a study with birds is not needed due to animal welfare reasons and the PNEC oral is not derived.