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:

In a GLP and OECD guideline 406 study Daltolac XR 159 was evaluated in the Magnusson-Kligman guinea pig maximization model of delayed hypersensitivity. Prior to experimental initiation of the induction, the irritation potential of the test article was determined with a dose range-finding studies (intradermal and topical) utilizing 8 naïve guinea pigs. Based upon these results, the intradermal dose utilized was 5%, the topical induction dose was 100% and the challenge dose utilized was 100% in the main study.

 

The main study was conducted with 10 animals for the test article group and five animals for the vehicle control group. 

No mortality was observed in any vehicle control or test article group animals in the study. No clinical signs were observed in any vehicle control group animals in the study. Decreased body tone was observed in one test article treated female on Day 21 through 25 of the study. No other clinical signs were noted in the test article treated group during the study.

Under the conditions of this study, an intradermal induction of Daltolac XR 159 at 5% with a topical induction at 100%, followed by a topical challenge at 100% to guinea pigs did elicit a dermal sensitization response at 24 and 48 hours post treatment. Therefore, Daltolac XR 159 is considered to be a contact sensitizer in Guinea Pigs.


Migrated from Short description of key information:
Based on a GLP and OECD guideline 406 study, Daltolac R 159 was considered to be sensitising.

Justification for classification or non-classification

Based on the results of the skin sensitizing test in Guinea pigs, Daltolac XR 159 is considered to be a contact sensitizer.

Classification and labelling of the substance according to Directive 67/548/EEC: R43

According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification is skin sen 1B, H317.