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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing in daphnia shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on daphnia. Safe use was shown in the CSR for all uses and environmental compartments. In addition, it is not expected from the nature of the substance that long-term effects will lead to more severe effects as compared with the acute results. In a biodegradation study (MITI, 2011), the test substance Sika Hardener LH was completely hydrolyzed to 2,2-dimethyl-3-oxopropyl dodecanoate and hexamethylenediamine. These converted products were biodegraded. The percentage (average) of biodegradation by BOD was 91 % after 28 days. Therefore, the test substance is considered to be readily biodegradable. In addition, the very low water solubility of SIKA Hardener LH will not lead to a high exposure of the aquatic compartment. Therefore and for reasons of animal welfare a long-term toxicity testing in daphnia is not provided.

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