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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Sediment toxicity

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Administrative data

Link to relevant study record(s)

Reference
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.

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.