Registration Dossier
Registration Dossier
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EC number: 605-140-1 | CAS number: 158237-07-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
Based on the acute effect concentrations, fish cannot be identified by far as the most sensitive organism and it is not expected that a chronic study will result in even lower effect concentrations compared to algae.
Key value for chemical safety assessment
Additional information
According to Regulation (EC) No 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
In acute aquatic toxicity tests algae (ErC50 (72 h) = 6.04 µg/L, NOErC (72 h) = 0.49 µg/L, initial measured) demonstrated being by far the most sensitive organisms, resulting in T (toxic) for PBT assessment. The difference between sensitivity demonstrated in fish (LC50 (96 h) = 1300 µg/L, nominal) and algae is factor 215. Therefore, it is neither to be expected that a chronic fish or aquatic invertebrates study will yield even lower effect values nor will it contribute to a more stricter toxicity (T) assessment. The substance is classified as Aquatic Chronic 1 (H410) and Aquatic Acute 1 (H400) according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs) which is the highest aquatic toxicity classification. According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), long-term testing with fish should only be conducted if it represents the most sensitive taxonomic group. Thus, and for reasons of animal welfare, long-term testing on fish is not proposed.
In addition, the environmental exposure assessment for the test substance according to Annex XI, Section 3 of Regulation (EC) No 1907/2006 indicates no risk for the aquatic compartment (all RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). Thus, a long-term test with fish is not deemed necessary. Since, the substance is a herbicide which implicates plants to be the most sensitive organism group with the highest expected toxicity. Thus, no higher toxicity is expected for fish than for algae and no chronic test is proposed for fish.
Hence, based on the acute effect concentrations, fish cannot be identified by far as the most sensitive organism and it is not expected that a chronic study will result in even lower effect concentrations compared to algae. Thus, due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish was proposed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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