Registration Dossier
Registration Dossier
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EC number: 203-571-6 | CAS number: 108-31-6
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
Long-term toxicity testing on birds is scientifically unjustified.
Key value for chemical safety assessment
Additional information
In Annex X of Regulation (EC) No 1907/2006, it is stipulated that in the 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 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". Specifically, maleic anhydride is not bioaccumulative hence secondary poisoning is of no concern. Therefore, and for reasons of animal welfare, a study on bird long-term toxicity is not considered to be required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
