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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.
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