Registration Dossier
Registration Dossier
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EC number: 416-600-4 | CAS number: -
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:
- Justification for type of information:
- The performance of a test for toxicity to birds is scientifically not justified. REACh Regulation (EC) No 1907/2006, Annex X, Sect. 9.6.1, Col. 2, states as follows:
“Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.”
Direct and indirect exposure of soil and soil macroorganisms is practically negligible, as:
1) HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of soil and soil macroorganisms during manufacturing and formulation is practically negligible.
2) Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure of soil and soil macroorganisms. During use HAT-ISO is included in three-dimensional matrices of polymeric, resinous material and completely retained.
Therefore, the direct and indirect release of HAT-ISO to soil and terrestrial organisms is practically negligible. Therefore, direct and indirect exposure of HAT-ISO to soil is highly unlikely and performance of a test for toxicity to terrestrial organisms is scientifically not justified. The Chemical Safety Assessment does not indicate the need to investigate toxicity to terrestrial organisms further. Moreover, there is comprehensive data on vertebrate toxicity available with the registered substance. Therefore, further testing would not be in line with animal welfare reasons. For more details on exposure assessment see risk assessment report in section 13.
Reference
Description of key information
The performance of a test for toxicity to birds is scientifically not justified.
Key value for chemical safety assessment
Additional information
The performance of a test for toxicity to birds is scientifically not justified.
REACh Regulation (EC) No 1907/2006, Annex X, Sect. 9.6.1, Col. 2, states as follows:
“Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.”
Direct and indirect exposure of soil and soil macroorganisms is practically negligible, as:
1) HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of soil and soil macroorganisms during manufacturing and formulation is practically negligible.
2) Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure of soil and soil macroorganisms. During use HAT-ISO is included in three-dimensional matrices of polymeric, resinous material and completely retained.
Therefore, the direct and indirect release of HAT-ISO to soil and terrestrial organisms is practically negligible. Therefore, direct and indirect exposure of HAT-ISO to soil is highly unlikely and performance of a test for toxicity to terrestrial organisms is scientifically not justified. The Chemical Safety Assessment does not indicate the need to investigate toxicity to terrestrial organisms further. Moreover, there is comprehensive data on vertebrate toxicity available with the registered substance. Therefore, further testing would not be in line with animal welfare reasons. For more details on exposure assessment see risk assessment report in section 13.
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.
