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Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Description of key information

Studies on long-term toxicity in fish are not available.


Existing hazard information and results from a Risk Assessment of the substance are considered sufficient to cover the endpoint.


 

Key value for chemical safety assessment

Additional information

According to paragraph 3.1 (Substance-tailored exposure-driven testing) of Section 1, Annex XI of Regulation (EC) No 1907/2006 (REACH), testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report.


A PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement (i.e. higher safety factors in the derivation of the PNEC), and the PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes.


The comparison of the derived PNEC with the results of the exposure assessment, covering all relevant exposures throughout the life cycle of the substance, shows that exposures are always below the derived DNEL or PNEC, i.e. RCRs below 1.


The safe use of the substance throughout its entire life cycle is demonstrated by this risk assessment. Accordingly, further testing is not warranted.


Furthermore, according to REACH Article 25(1), animal testing should be used as a last resort. The available information on the registration item is sufficient to clearly demonstrate the safe use of the substance throughout its life cycle. Further testing may possibly refine the Assessment, but will not change its main conclusions. Therefore, additional testing on vertebrates would violate the requirements of animal welfare.