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EC number: 270-451-8 | CAS number: 68440-34-6
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility
Key value for chemical safety assessment
Additional information
No studies are available on the short-term toxicity of Fatty acids, tallow, zinc salts to fish. In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, a read across to the structural analogue Fatty acids, C16-18, zinc salts (CAS No. 91051-01-3) was conducted. Based on similar structure, physico-chemical properties and zinc content, the ecotoxicological profile of the two substances is expected to be comparable. Further justification is given within the endpoint summary 6.1 and the read-across justification. The data available for Fatty acids, C16-18, zinc salts and the supporting data available for inorganic zinc substances are discussed below.
Fatty acids, C16 -18, zinc salts:
Fish toxicity data on Fatty acids, C16 -18, zinc salts are available from a study performed according to EU Method C.1 (Acute Toxicity for Fish) in the former version of 1992 (Henkel KGaA, 1995), from a study performed according to OECD Guideline 203 (Fish, Acute Toxicity Test) but reported only in a short study report (TÜV Bayern, 1992) and from an old publication (Dowden and Bennett, 1965). None of the studies do fully comply with the requirements of the recent guidelines regarding performance and/or documentation. They are thereforecombined in a Weight of Evidence (WoE) approach, which is in accordance to the REACh Regulation (EC) No 1907/2006, Annex XI, 1.2, to adapt the data requirements of Regulation (EC) No 1907/2006 Annex VII - X (ECHA guidance section R.7.11.5.3).
In the most reliable study (Henkel KGaA, 1995), the acute toxicity of fatty acids, C16 -18, zinc salts to fish was investigated according to EU Method C.1 (Acute Toxicity for Fish) in the former version of 1992. Fish (Danio rerio) were exposed for 96 hours to nominal concentrations of 0 (control), 1000, 3000 and 10000 mg/L under semi-static conditions. Up to and including the highest nominal test concentration neither behavioural abnormalities nor mortality occurred. The test was conducted at nominal concentrations far exceeding the water solubility by 3 to 4 orders of magnitude. Measures to disperse the test substance in the test water were used. The actual test concentrations were below the detection limit (1 mg/L) of the analytical method used. Therefore, a numeric value for the actually test concentrations cannot be given. However, due to the very high level of nominal test concentrations and the measures used to disperse the test substance in the test medium, it is very likely that the actual test concentrations included the water solubility limit which is in the range of 1 mg/l (c.f. EU risk assessment zinc distearate carried out within the framework of EU Existing Chemicals Regulation (EEC) No 793/93 (Final report R074_0805_env, May 2008). No effects were observed at nominal fatty acids, C16 -18, zinc salts concentrations up to the water solubility limit in the two further studies either. In accordance to the evaluation given in the EU Risk assessment, from the results of these tests it is concluded, that the toxicity of the substance fatty acids, C16 -18, zinc salts to fish is (far) above the water solubility limit.
The test results are not suitable to derive a PNEC, since no measured value on actually tested concentrations can be given. However, a PNEC for aquatic fish toxicity is not necessary either as up to and including the water solubility limit, the test substance has proved to be nontoxic to fish.
ZINC:
Good quality and relevant data for 5 species. Tests were done according to standard protocol or equivalent.
Data are grouped per species according to
-pH: low (6 -<7) - neutral/high (7 -8.5)
-and hardness: low/medium (< 100mg CaCO3/L) and medium/high (>100 mg CaCO3/L).
Fish are generally less sensitive than invertebrates and algae. For a comprehensive overview of the acute toxicity of (soluble) zinc to fish,see Chemical Safety Assessment of "Zinc" within the framework of Regulation (EC) No 1907/2006 in the technical dossier (IUCLID section 13).
CONCLUSION:
Based on the study conducted with the structural analogue Fatty acids, C16 -18, zinc salts, the substance Fatty acids, tallow, zinc salts is not expected to have short-term effects on fish up to its limit of water solubility. The data for soluble zinc salts shows that fish are generally less sensitive than invertebrates and algae.
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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