Registration Dossier

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).

Castor 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.

 

For completeness, the following data on a similar castor oil salt has been reported as further conservative example, due to the presence of Zinc: International Bio-Research, Inc (1977a)[1] conducted a skin sensitization study on Grillocin HY 77 (now TEGODEO HY77) using 30 white guinea pigs (average weight = 300 g).

TEGODEO HY 77 (trade name mixture for Zinc Ricinoleate) has the following composition: Zinc Ricinoleate (more than 50%), triethanolamine (10% to 25%), dipropylene glycol (1% to 5%), and lactic acid (1% to 5%) (Degussa 2001). Test and control groups consisted of 20 and 10 guinea pigs, respectively. A closed patch containing the trade mixture (0.5 ml, undiluted) was placed on the left shoulder, clipped free of hair, of each animal and remained in place for 6 h. Treatments were repeated once weekly for 3 weeks.

At two weeks after the last exposure, test and control guinea pigs were challenged (same procedure, right side) with duplicate closed patches. At 24 h post removal of the patches, the test site on each animal was treated with a depilatory. Sites were then rinsed and reactions were graded 2, 24, and 48 h later according to the method of Draize. Clinical observations were normal throughout the study. Erythema and eschar formation were graded according to the following scale: 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). The following scale for edema formation was used: 0 (no edema) to 4 (severe edema [raised more than 1 mm and extending beyond area of exposure]). A score of 0 (erythema and edema) was reported for each test and control animal during each of the three grading periods. Grillocyn HY 77 did not produce a positive reaction in any of the test animals.

 

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.[2]

 

[1 ] International Bio-Research, Inc. 1977a. Delayed contact sensitization (guinea pigs). Compound: “Grillocin HY 77” (undiluted) (Translation). Unpublished data submitted by CTFA. 18 pages

[2] SIDS Initial Assessment Report for SIAM 25, 16 -19 October 2007, Helsinki, Category of Alkyl sulfates, Alkane sulfonates and α - Olefin sulfonates

 Migrated from Short description of key information: No data are available for the sulphated substance. Read across from similar substances (sulfited fat liquors EC 307-037-4 fish oil and EC 281-975-1 rape oil) indicate the substances are not sensitizing. Justification for selection of skin sensitisation endpoint: FFL sample 3 , fish oil sulphited derivative sodium salt and FFL sample 4, rape oil, sulphited sodium salt, have been considered in a Weight of Evidence

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