Registration Dossier
Registration Dossier
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EC number: 203-988-3 | CAS number: 112-59-4
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Long-term toxicity to fish is not to be expected.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- NOEC
- Remarks:
- Chronic Value
- Effect concentration:
- 63 mg/L
Additional information
The long-term toxicity to fish was determined using a valid QSAR model (ECOSAR v2.0; BASF SE, 2022). The model predicts the chronic value ChV, which is defined as the geometric mean of the no-observed-effect concentration (NOEC) and the lowest-observed-effect concentration (LOEC). The ChV for the substance was predicted to be 63 mg/L. The substance is within the applicability domain of the model. The chronic value is clearly greater than 1 mg/L with regard to classification limits and also greater than 10 mg/L, which the limit concentration in long-term toxicity testing; therefore, long-term effects on fish are not to be expected.
This value is in agreement with the expectation that fish is not the most sensitive trophic level based on the available data.
In Annex IX, Section 9.1.6, Column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as hazardous according to CLP-Regulation (EC) No 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB.
The Substance is readily biodegradable (see IUCLID Ch. 5.2.1); therefore, it is not P/vP. The Substance has a low log Kow (see IUCLID Ch. 4.7); therefore, it is not B/vB. The available toxicity data do not support that the Substance could be T. Therefore, it can be concluded that the Substance is not PBT/vPvB. The hazard assessment of the Substance does not reveal a need to classify the substance as hazardous to the environment according to Regulation EC 1272/2008 and its second adaptation 286/2011.
In Annex XI, Section 3, it is laid down that testing in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10).
In addition, an expert judgement (BASF SE, 2022) has been provided which demonstrates that the Substance does not have a specific mode of action or produces alerts for protein binding. The available experimental data on toxicity to aquatic organisms together with a valid QSAR result for long-term toxicity on fish shows that fish are not expected to have a higher sensitivity than the other trophic levels. Therefore, further testing would not lead to a different assessment of the environmental impact.
Therefore, and for reasons of animal welfare, a long-term toxicity test on fish is not provided.
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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