Fatty acids, C16-18 (even numbered), ammonium salts

Endpoint summary

Description of key information

Short-term toxicity to fish: Data waiving (study scientifically not necessary): In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since there are mitigating factors indicating that aquatic toxicity is unlikely to occur. The substance is highly insoluble in water.

Long-term toxicity to fish: Data waiving (study scientifically not necessary): According to the communication number CCH-D-2114328744-46-01/F, and according to ECHA Guidance on information requirements and chemical safety assessment (version 3.0, February 2016), Chapter R7b (Section R.7.8.5., including Figure R.7.8-4), if based on acute aquatic toxicity data neither fish nor invertebrates are shown to be substantially more sensitive, long-term studies may be required on both. In such case, according to the integrated testing strategy, the Daphnia study is to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.

The long-term Daphnia test concluded that the Test item did not affect the reproduction of Daphnia magna at a loading rate of 1.0 mg a.i./L after 21 days of exposure (saturation concentration), being the NOAEL equal to 1.0 mg a.i./L and EL50 greater than 1.0 mg a.i./L. Based on these results, the substance is not classified for aquatic toxicity according to CLP Regulation and  no risk assessment is necessary to be performed according to REACH Regulation. Therefore, it is concluded that the long-term fish testing is not scientifically justified.

Short-term toxicity to aquatic invertebrates: Data waiving (study scientifically not necessary): In accordance with column 2 of REACH Annex VII, the study does not need to be conducted since there are mitigating factors indicating that aquatic toxicity is unlikely to occur. The substance is highly insoluble in water.

Long-term toxicity to aquatic invertebrates: Key study: OECD Guideline 211. GLP study. Test item did not affect the reproduction of Daphnia magna at a loading rate of 1.0 mg a.i./L after 21 days of exposure, being the NOAEL equal to 1.0 mg a.i./L and EL50 greater than 1.0 mg a.i./L.

Toxicity to aquatic algae and cyanobacteria: Data waiving (study scientifically not necessary): In accordance with column 2 of REACH Annex VII, the study does not need to be conducted since there are mitigating factors indicating that aquatic toxicity is unlikely to occur. The substance is highly insoluble in water.

Toxicity to microorganisms: Weight of evidence: Based on the experimental results obtained with the analogue substance, the weight of evidence approach was applied and the NOEC for microorganism toxicity for the substance Fatty acids, C16-18 (even numbered), ammonium salts was determined to be 100 mg/L (worst case assumption).