Fatty acids, C12-14, .alpha.-sulfo, disodium salts

Toxicity to terrestrial plants

Description of key information

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. 7.11.6.3, 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 plant study: In acute aquatic tests, fish and daphnids were more sensitive (fish factor 20) than aquatic algae (fish LC50: 5.72 mg/L, acute Daphnia EC50: 93 mg/L, algae ErC50 116 mg/L). This observation is also valid when chronic data (EC10 daphnia: >10 mg/L, algae: ErC10: 67 mg/L) were compared. Based on the results, aquatic algae 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 plants are less sensitive compared to terrestrial invertebrates. In this case, testing of terrestrial plants would not contribute to a higher margin of safety. In contrast, an additional plant 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 plants and consequently terrestrial plant toxicity tests are not needed.

Additional information

The Guidance on information requirements and chemical safety assessment, Chapter R.7C: Endpoint specific guidance (June 2017), section R. 7.11.6.3, 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 ready biodegradable. The log Pow of Fatty acids, C12-14, α-sulfo, disodium salts 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. Moreover, 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 the 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 plant study: In acute aquatic tests, fish and daphnids were more sensitive (fish factor 20) than aquatic algae (fish LC50: 5.72 mg/L, acute Daphnia EC50: 93 mg/L, algae ErC50 116 mg/L). This observation is also valid when chronic data (EC10 daphnia: >10 mg/L, algae: ErC10: 67 mg/L) were compared. Based on the results, aquatic algae 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 plants are less sensitive compared to terrestrial invertebrates. In this case testing of terrestrial plants would not contribute to a higher margin of safety. In contrast, an additional plant 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 plants and consequently terrestrial toxicity tests are not needed.