Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The derived NOEC of > 1 mg/L indicates that long-term effects on fish are not to be expected.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
Effect concentration:
> 1 mg/L

Additional information

The information requirements will be fulfilled using a weight-of-evidence approach based on the scheme provided in REACH Guidance Document R.7b (v4.0, ECHA, 2017: Figure R.7.8-2) and in accordance with Annex XI Section 1.2.
Step 1: The structure as well as the physico-chemical properties of the Substance are clearly identified. Despite the Substance was found to be readily biodegradable in screening tests, the Registrant provided additional information for the calculated biodegradation metabolites of the substance (CATALOGIC 301C v.11.16, BASF SE, 2020). This QSAR estimation model identified 2 metabolites as relevant degradation products in terms of PBT/vPvB assessment, with an estimated quantity of ≥ 0.1% (for details see ‘Attached background material’ of the respective Endpoint Study Record, IUCLID, Ch. 5.2.1). All relevant metabolites were calculated to be readily biodegradable (≥ 60% after 28 days, based on BOD), therefore it can be concluded that the degradation products of the Substance are not P/vP. Moreover, all metabolites have a log Kow ≤ 3, thereby not fulfilling the screening criteria for bioaccumulation (B/vB) as laid down in Section 3.1 of REACH Annex XIII. Based on modeled data relevant degradation products do neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB).
Step 2: The substance does not produce an alert for protein binding in the schemes by OECD and OASIS (BASF SE, 2021) which is an indication of the absence of elevated toxicity. According to the mode of action by OASIS (BASF SE, 2020), the substance is a narcotic amine. The modified classification scheme of Verhaar is not suitable to classify the Substance. It can be concluded that critical long-term effects are not to be expected.
Step 3 and 4: No experimental data are available on the long-term toxicity to fish for the Substance.
Step 4a/b: Reliable QSAR predictions or in-vitro results for long-term toxicity to fish are not available.
Step 5: Acute and long-term toxicity for the aquatic environment have been assessed by experimental data for the Substance itself. Information on the long-term toxicity to fish are not available.
Fish are not the most sensitive aquatic trophic level (96-h LC50 > 100 mg/L). The Substance is neither acutely nor chronically hazardous to the aquatic environment according to the CLP-Regulation (EC) No 1272/2008.
The long-term toxicity to fish is derived using the Acute-to-Chronic (ACR) approach. The detailed description as well as the result of the ACR approach is in the update of the IUCLID as part of IUCLID Chapter 6.1.2. The ACR approach is an important method to predict acceptable no-effect values (NOEC) from acute toxicity data (LC50, EC50). The method is valuable for the risk assessment of chemical substances, which has been successfully assessed for several chemicals, including organic substances (including alkylamines) with a narcotic mode of action to which the Substance belongs (May et al., 2016; Kienzler et al., 2016; ECETOC, 2003). Based on these three publications, a conservative ACR of 100 was selected which covers at least 90% of all organic chemicals; therefore, the derived NOEC can be regarded as reliable and sufficiently protective.
Based on the available 96-h LC50 > 100 mg/L (NITE, 2003) a NOEC for the long-term toxicity to fish was estimated to be > 1 mg/L. The available short-term as well as the long-term toxicity data do not lead to a classification of the Substance as chronically hazardous to the aquatic environment following the CLP-Regulation (EC) No 1272/2008.
With regard to the PBT assessment, further testing is also not required as the Substance is neither bioaccumulative (B) nor very bioaccumulative (vB) based on the experimentally determined BCF (BCF < 3.9 L/kg; MITI, 1979) supported with the estimated BCF value (3 – 9.3 L/kg, OASIS Catalogic v., BASF SE, 2020). The substance is within the applicability domain of the QSAR estimation model. As the Substance does not fulfil the P/vP and B/vB criteria at the same time, it is concluded that the Substance is not considered as a PBT/vPvB substance. The available short-term as well as the long-term toxicity data for the three trophic levels (fish, aquatic invertebrates and algae) do not indicate a concern for a high sensitivity of aquatic organisms. Therefore, further testing does not seem justified and long-term toxicity testing on fish should therefore not be carried out to avoid unnecessary testing on vertebrate animals.
Avoiding unnecessary testing of vertebrate animals is also in line with the REACH regulation, which states in §25 that testing on vertebrate animal shall be undertaken as a last resort. This is further supported by the EU Directive on the protection of animals used for scientific purposes (EU, 2010) and the EURL ECVAM strategy to replace, reduce and refine the use of fish in aquatic toxicity and bioaccumulation testing (EURL ECVAM, 2014).
Step 6: The intrinsic properties of the Substance indicate that significant and relevant long-term effects on fish will not occur. The Substance has no specific mode of action and does not produce structural alerts for relevant effects. The derived NOEC of > 1 mg/L indicates that long-term effects on fish are not to be expected.
Therefore, and in accordance with REACH Regulation 1907/2006, Annex XI, Section 1.2, further testing on vertebrate animals will be omitted for reasons of animal welfare, no long-term toxicity tests on fish will be performed.