Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

For this endpoint, the read across between PWH/ammonium and PWH/sodium salt is valid, because this toxicological property is defined by the main component. The read across justification that takes into account the ammonium ion properties is attached on section 13 of the dossier.

The potential of the test item, Paraffin waxes and hydrocarbon waxes, chloro, sulfochlorinated saponified (C18-C30) SSP-SAMPLE 3, to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the methods of Buehler.

At challenge, response was observed in a total of 6/20 animals of the test group (30%) following treatment with the test item at 20% concentration in acetone. No reaction was observed in the control group animals at sites treated with the test item at the same concentration or in any animal at sites treated with the vehicle alone (acetone).

The validity of the test system was verified with periodic testing of the positive control.

These results indicate that the test item, Paraffin waxes and hydrocarbon waxes, chloro, sulfochlorinated saponified (C18-C30) SSP-SAMPLE 3, may elicit a sensitisation response in the guinea pig, since there was evidence of response at challenge following a period of induction exposure to the test item.

A LLNA study has also been performed on the similar substance "Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified" on a dose-range where the irritating effect seems not being interfering with the test result, and the same elicitation potential has been found


Migrated from Short description of key information:
The substance elicit sensitizing potential on a buhler test

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the reported test results, the European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:

Classification           Category 1B

Signal word               Warning

Hazard statement    H317: may cause an allergic skin reaction

Criteria for category IB Buhler test have been set in the II amendment, Regulation 286/2011:

Buehler assay Category IB:

≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or

≥ 15 % responding at > 20 % topical induction dose