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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

Based on the acute effect concentrations, aquatic invertebrates cannot be identified 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, 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 aquatic invertebrates (EC50 (48 h) = 100 µg/L, nominal) and algae is around factor 16. According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), there are no further requirements for invertebrate testing if there is compelling evidence to suggest that the invertebrate value is likely to be at least a factor of about 10 less sensitive than algae or fish. Therefore, it is neither to be expected that a chronic aquatic invertebrate study will yield even lower effect values nor will it contribute to a more stricter toxicity (T) assessment compared to algae. 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.

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 aquatic invertebrates 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, aquatic invertebrates cannot be identified 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, no further long-term test with aquatic invertebrates was proposed.