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Long-term toxicity to aquatic invertebrates

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Description of key information

NOELR (21 d) ≥ 100.0 mg/L (nominal, OECD 211, D. magna)

Key value for chemical safety assessment

Additional information

As no valid study is available for the long-term toxicity of Alcohols, lanolin, distn. residues (CAS No. 90622-40-5) to aquatic invertebrates, a read-across to the structurally related substance Alcohols, lanolin (CAS 8027-33-6) was conducted in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances. The read across is justified on the basis of the structural and physico-chemical similarity of the two substances, as well as their comparable environmental fate/ecotoxicological and toxicological behavior. A detailed analogue approach justification is provided in IUCLID section 13.

The available study with the source substance Alcohols, lanolin (CAS No. 8027-33-6) assessed the long-term toxicity to Daphnia magna according to the OECD guideline 211 and GLP. This study was performed as a reproduction test exposing D. magna to a single, nominal loading rate of 100 mg/L for 21 d under semi-static conditions. The test solution was prepared as water-accommodated fraction (WAF) and the concentration and stability of the test item in the test preparations was verified by GC-FID on days 0, 5, 14, 16, and 19 (fresh media) and on days 2, 7, 16, 19, and 21 (old media).

The measured concentrations in the fresh media ranged from 0.018 to 0.054 mg/L. A decline in the measured concentrations was observed in the corresponding old media to below the limit of quantification of the method at 0.0098 and 0.017 mg/L. Since the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on the nominal loading rate only.

After 21 d, no significant mortalities (immobilization) in the parental generation (P1) and no significant differences (p ≥ 0.05) in terms of number of live offspring produced per adult were observed when compared to the control. The derived No Observed Effect Loading Rate (NOELR) was ≥ 100 mg/L.

This result also applies to Alcohols, lanolin, distn. residues (CAS No. 90622-40-5), due to the structural and physico-chemical similarity to the analogue substance, Alcohols, lanolin (CAS 8027-33-6). Therefore, no long-term effects on aquatic organisms are expected up to the limit of water solubility of Alcohols, lanolin, distn. residues.