Registration Dossier
Registration Dossier
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EC number: 262-992-3 | CAS number: 61788-64-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Annex VII of the REACH Regulation includes a requirement for in chemico/in vitro tests as a first step for addressing skin sensitisation (section 8.3.1). Only in the case that the in chemico/in vitro methods are not applicable for the substance, or the results are not adequate for classification and risk assessment, can an in vivo skin sensitisation study (preferably Local Lymph Node Assay, EU B.42 / OECD TG 429) be performed (section 8.3.2).
Fish oil sulfated sodium salt is a complex UVCB substance which shows very low water solubility and has logKow (estimated) > 12, which are parameters that set the substance out of the applicability domains of the in-place validated in vitro testing. Consequently, a trigger for an in vivo testing needs to be considered. However, certain steps need to take place before any testing (in vitro or in vivo) is conducted as described in the introductory paragraph to Annex VII, i.e. assessment of all available information, which among other suggest to consider data from structurally related substances (read-across approach).
FLL samples were therefore establish to be appropriate for read across strategy and used to assess the skin sensitization potential. The substances were tested in an OECD 406 (GPMT in 2013) and under the experimental conditions are not considered skin sensitizers.
Two sulphited analogous, FLL sample 3 (fish oil derivative) and FLL sample 4 (rape oil derivative), for which the Robust Study Summary have been reported are therefore considered. For this endpoint sulphited are considered a conservative case, because of their higher absorption and lower degradation.
Also alkyl sulfates were not sensitizing in various studies, including adjuvant (guinea pig maximizatio tests) and non-adjuvant (Buehler test) protocols in accordance with OECD TG 406. Alkyl sulphated results are used as a demonstration that the sulphatation functionality doesn't influence this endpoint.[1]
[1] SIDS Initial Assessment Report for SIAM 25, 16 -19 October 2007, Helsinki, Category of Alkyl sulfates, Alkane sulfonates and α - Olefin sulfonates
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is not classified for skin sensitisation according to CLP criteria set out in the EC 1272/2008 Regulation
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.
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