Registration Dossier
Registration Dossier
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EC number: 283-829-2 | CAS number: 84731-70-4
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to birds
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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