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Ecotoxicological information

Toxicity to birds

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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

Endpoint waived due to the low bioaccumulation potential of the substance in aquatic organisms and absence of toxicity in mammalian dataset.

Key value for chemical safety assessment

Additional information

According to Regulation (EC) No. 1907/2006, Annex X, Section 9.6.1 Column 2: Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.

This assessment criteria are expanded in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c: Endpoint specific guidance, Version 3.0, June 2017, Section R.7.10.21.2 Preliminary considerations.  This section lists conditions where No avian toxicity data are available that could lead to avian studies being required:

1) Potential to contaminate food chains: Bioaccumulation potential of the substance is however very low.   A bioaccumulation study has shown the mean BCF to be 9. The substance was shown not to significantly accumulate in fish tissue and was observed to be eliminated from the fish tissues over a 25 day depuration period. Based on this information the biological half-life of the test item is considered to be between 6 to 25 days.  

2) Evidence of toxicity in mammalian repeat dose or reproductive toxicity studies: The substance has a large mammalian toxicity dataset showing low toxicity and no triggering any hazard classifications.  

In conclusion, due to the low bioaccumulation potential of the substance in aquatic organisms secondary poisoning is not considered to be a route of exposure that has to be further assessed for this substance. Furthermore, the substance has a large mammalian dataset already, showing low toxicity. Therefore the long-term or reproductive toxicity to birds endpoint is waived.