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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.
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.
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