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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. 22.214.171.124, 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
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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