Registration Dossier
Registration Dossier
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EC number: 269-124-2 | CAS number: 68187-77-9
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:
See attached file
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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).
Castor oil sulfated ammonium 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 werr 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.
Based on the read across considerations same results apply to the target substance
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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