Registration Dossier

Diss Factsheets

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