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:

Procedure and observations

The dermal sensitization potential of the test substance (TS) was evaluated in two studies.

In the first study, ten male and ten female Hartley-derived albino guinea pigs received intradermal injections of 1.0% w/v TS in polyethylene glycol 400 (PEG 400) along with injections of FCA and TS in FCA. One week later, the test animals received a topical application of 100% TS. Challenge and rechallenge control animals received similar intradermal and topical treatments except PEG 400 was used in place of the test article. Following a two-week rest period, a challenge was performed whereby the twenty test and ten challenge control guinea pigs were topically treated with 100% w/v TS. Challenge responses in the test animals were compared with those of the challenge control animals. Following challenge with 100% TS, dermal scores of 0 were noted in all test animals, while dermal scores of 0 were noted in all challenge control animals. Group mean dermal scores in the test animals were comparable to the challenge control animals.

In a second irritation study, the test material was administered as 1% w/v mixtures in mineral oil and Freund's Complete Adjuvant (FCA) for the intradermal injection phase and as a 50% w/w mixture in petrolatum for both the topical induction and challenge applications in the definitive study. A definitive sensitization test according to the method of Magnusson and Kligman was then conducted. None of the animals in the test or irritation control groups exhibited a dermal reaction to the challenge application of the test or control materials.

 

Discussion

In two sensitisation studies, the test substance did not cause any allergic reaction. Therefore, the substance is considered to be not sensitizing to skin.

 

 

 


Migrated from Short description of key information:
The allergic potential of the test substance was evaluated in two independent studies with guinea pigs (according GLP and OECD guideline 406). In none of the studies the substance revealed any allergic reaction to skin and is therefore not consideredto be sensitizing.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No experimental data is available regarding respiratory sensitisation. The particle size of the test substance is 1-2 mm and, therefore, not inhalble. Moreover, the test material did not reveal allergic potential in skin sensitisation tests, whereby respiratory sensititsation is not expected.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC,as amended for the 30th time in Directive 2008/58/EC.

                               

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).