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Ecotoxicological information

Long-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance column 2 of REACH Annex IX, the long-term testing on fish study (required in section 9.1.6) does not need to be conducted as the hazard assessment performed during the chemical safety assessment concludes that the substance is classified for the highest environmental hazard - for both acute and chronic environmental toxicity (category 1). Hence, the performance of additional environmental toxicity tests will not impact on the hazard classification, or resultant risk management measures (which will already be very stringent), and will therefore not provide any additional benefit regarding the safe use of this chemical.
In summary, the available data are adequate for classification and labelling purposes and for PBT assessment and provision of additional environmental information will not further the safe use of this substance.
Furthermore, the experience gained with acute ecotoxicity tests allows to conclude that fish is not the most sensitive species when exposed to MOT(EHMA). Therefore for ethical reasons, the notifier considers that long-term fish test is not relevant.

Description of key information

In accordance column 2 of REACH Annex IX, the long-term testing on fish study (required in section 9.1.6) does not need to be conducted as the hazard assessment performed during the chemical safety assessment concludes that the substance is classified for the highest environmental hazard - for both acute and chronic environmental toxicity (category 1). Hence, the performance of additional environmental toxicity tests will not impact on the hazard classification, or resultant risk management measures (which will already be very stringent), and will therefore not provide any additional benefit regarding the safe use of this chemical.

In summary, the available data are adequate for classification and labelling purposes and for PBT assessment and provision of additional environmental information will not further the safe use of this substance.

Furthermore, the experience gained with acute ecotoxicity tests allows to conclude that fish is not the most sensitive species when exposed to MOT(EHMA). Therefore for ethical reasons, the notifier considers that long-term fish test is not relevant.

Key value for chemical safety assessment

Additional information