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EC number: 942-523-5
CAS number: 2156594-77-1
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. 184.108.40.206, 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. 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
Further argumentation for the waiving of the Soil macroorganisms
except 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 soil macroorganisms except arthropods have a
limited sensitivity towards the registered substance. Consequently,
testing of soil macroorganisms except arthropods would not contribute to
a higher margin of safety. In contrast, an additional soil
macroorganisms except 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 Soil
macroorganisms except arthropods and consequently additional terrestrial
toxicity tests are not needed.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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