Registration Dossier
Registration Dossier
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EC number: 416-600-4 | CAS number: -
Sediment toxicity
Administrative data
Link to relevant study record(s)
- Endpoint:
- sediment toxicity: long-term
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- The performance of a test for long-term toxicity on sediment organisms is scientifically unjustified. REACh Regulation (EC) No 1907/2006, Annex X, Sect. 9.5.1, Col. 2, states as follows:
“9.5.1: Long-term toxicity shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further effects of the substance and/or relevant degradation products on sediment organisms. The choice of appropriate test(s) depends on the results of the chemical safety assessment.”
Direct and indirect exposure of sediment is practically negligible, as: 1) HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of sediment during manufacturing and formulation is practically negligible. 2) Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure to sediment. 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 sediment is practically negligible. Thus, direct and indirect exposure of sediment is practically negligible and long-term toxicological testing on sediment organisms is scientifically not justified. For more details on exposure assessment see the CSR in section 13.
Reference
Description of key information
The performance of a test for long-term toxicity on sediment organisms is scientifically unjustified.
Key value for chemical safety assessment
Additional information
The performance of a test for long-term toxicity on sediment organisms is scientifically unjustified.
REACh Regulation (EC) No 1907/2006, Annex X, Sect. 9.5.1, Col. 2, states as follows:
“9.5.1: Long-term toxicity shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further effects of the substance and/or relevant degradation products on sediment organisms. The choice of appropriate test(s) depends on the results of the chemical safety assessment.”
Direct and indirect exposure of sediment is practically negligible, as:
1) HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of sediment during manufacturing and formulation is practically negligible.
2) Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure to sediment. 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 sediment is practically negligible. Thus, direct and indirect exposure of sediment is practically negligible and long-term toxicological testing on sediment organisms is scientifically not justified. For more details on exposure assessment see the CSR 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.
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