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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 9.1, Col. 2, states as follows:
“9.1.: 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. The choice of the appropriate tests(s) depends on the results of the chemical safety assessment."
The chemical safety assessment does not indicate the need to further investigate effects on aquatic organisms as outlined in the following. This is also in line with the rule of information requirement adaptation due to no scientific necessity as stated in Annex XI section 1.
The substance was investigated in OECD and GLP compliant studies for its acute toxicity to algae, daphnia, and fish, respectively. The test item is practically insoluble in aquatic media, therefore, supersaturated solutions of the test item were prepared for each test and the biological effects are based on loading rates. In all three trophic level tests, the test item showed no effects up to the water solubility. The E(L)C50 values were determined to be for all three species above 1000 mg/L (loading rate). The NOECs for all performed aquatic studies was determined to be ≥1000 mg/L (loading rate).
Taken together, the test item did not induce any effects in fish, daphnia and algae up to the water solubility. This is also assumed for long-term toxicity. NOEC values for a long-term Daphnia test are expected to be well above the water solubility of the test item. Therefore, long-term toxicity studies on Daphnia are not expected to provide more relevant information in regards to hazard conclusion and would therefore not improve chemical safety assessment.
Furthermore, based on the chemical safety assessment the environmental risk is considered to be adequately controlled. There are no concerns regarding the safe use of the substance. For the aquatic environment RCR values are beyond the threshold of 1.
Taking together the points outlined above, it is concluded that the criteria of Annex IX Section 9.1, column 2 are fulfilled justifying the adaptation of the information requirements, accordingly. Therefore, further studies on long-term toxicity to daphnia are neither scientifically nor from a regulatory point of view justified.
This is also in line with the rule of information requirement adaptation as stated in Annex XI section 1. Further testing does not appear to be scientifically necessary.

Description of key information

REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 9.1, Col. 2, states as follows: 9.1.:

"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. The choice of the appropriate tests(s) depends on the results of the chemical safety assessment."

A study assessing the long-term toxicity of the test item 1,1'-(1,1,2,2-tetramethylethylene)dibenzene towards aquatic invertebrates (Daphnia sp.) according to OECD 211 guideline is currently not available. The studies assessing the short-term toxicity of the test item towards fish, aquatic invertebrates (Daphnia sp.) and algae clearly show no adverse effects up to the test item's water solubility.

No adverse effects in long-term studies are expected. Ad additional study would thus not improve the environmental risk assessment.

Key value for chemical safety assessment

Additional information