Registration Dossier
Registration Dossier
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EC number: 701-237-9 | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Data waived on the basis that the substance is highly soluble in water, there was no short-term toxicity to fish below 100 mg/l, long-term toxicity to invertebrate data are available and the RCRs are <1.
Key value for chemical safety assessment
Additional information
A 14 d NOEC value of 60 mg/L (as active acid) has been determined for the effects of HEDP-H on the altered behaviour and loss of equilibrium of the freshwater fish Salmo Gairdneri (now known as Onychorhynchus mykiss).
A 14 day LC50 of 180 mg/L (as active acid) has also been determined based on mortality. For details on the study refer to KEY (r-a) 14 d Short-term toxicity to fish, ABC 1979. It is possible to read across these values to HEDP (1-2Na) based on the information reported in the Short-term toxicity to fish Endpoint Summary.
A longer toxicity testing with fish is not considered necessary because:
In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio (PEC/PNEC) is below 1, and therefore the risk is already adequately controlled and further testing is not justifiable. The substance is highly water-soluble and not bioaccumulative, there are short-term fish toxicity data on 7 species which show effects at concentrations >100 mg/l, and long-term aquatic invertebrate toxicity data available with this substance does not suggest unpredictable long-term toxicity and suggest a simple acute:chronic relationship. Therefore, the occurrence of toxic effects that were not expressed in the existing short-term aquatic studies (conducted at concentrations up to 18 g/L) would be considered unlikely. A PNEC has been derived for the purpose of chemical safety assessment and overall it is concluded that the risk characterisation conclusion is sufficiently conservative and therefore further in vivo testing is not considered necessary/justified on ethical grounds. Details on how the PNEC and the risk characterisation ratios have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.
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