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Toxicity to terrestrial arthropods

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In addition to REACH Annex IX, section 9.4 column 2, the Guidance on information requirements and chemical safety assessment, Chapter R.7C: Endpoint specific guidance (June 2017), section R., Table R.7.11-2, page 158, specifies the information needed to waive the terrestrial studies based on soil hazard categories.  Fatty acids, C12-14, α-sulfo, disodium salts is readily biodegradable and the log Kow is <3. Therefore, accumulation and persistence of Fatty acids, C12-14, α-sulfo, disodium salts in soil and organisms is very unlikely. Furthermore, the registered substance is only moderately toxic to pelagic aquatic organisms. In addition, a PNEC soil of 1 mg /kg soil dw was determined from a study with soil microorganisms (OECD 216) with the registered substance itself. Based on an EC10 of 1000 mg/kg dw the PNEC of 1 mg/L soil dw was deviated resulting in a PEC/PNEC ratio of < 1 for the soil compartment.

Further argumentation for the waiving of the terrestrial arthropods study: In acute aquatic tests, daphnids were quite insensitive (acute Daphnia EC50: 93 mg/L). This observation is further supported by chronic data for daphnia (OECD 211; EC10 daphnia: >10 mg/L). Based on the results, aquatic invertebrates are considered not to be the relevant species for the aquatic risk assessment. Therefore, taking into account the results from the aquatic environment, it can also be assumed that the terrestrial arthropods have a limited sensitivity towards the registered substance. Consequently, testing of terrestrial arthropods would not contribute to a higher margin of safety. In contrast, an additional terrestrial arthropods test would decrease the applied safety factor resulting in a higher PNEC.

Based on the characteristics of Fatty acids, C12-14, α-sulfo, disodium is not expected to cause adverse effects on terrestrial arthropods and consequently additional terrestrial toxicity tests are not needed.

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