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
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Key value for chemical safety assessment

Additional information

Waived per Annex X; Column 1, Paragraph 9.6.1: Long-term or reproductive toxicity to birds; Column 2; Paragraph 9.6.1 - "Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level."

Based on the available test data for the registration substance, which includes sub-chronic repeated dose toxicity testing, pre-natal development testing and two-generation reproductive toxicity, it is evident that it is of low toxicological concern. There is also negligible release to environmental compartments, with RCRs <0.02 for all exposure scenarios. Although it is acknowledged that mammalian testing is not necessarily predictive of avian toxicity, the negligible releases to the environment and absence of inherent toxicity of the registration substance are seen as sufficient grounds to waive any further requirements for Avian toxicity testing.