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

 

To assess the allergenic potential of the test article in albino guinea pigs (10/sex/dose) the Maximization-Test (OECD guideline 406) was used. After intradermal and epicutaneous induction, the animals were challenged epicutaneous with a 10% solution of the substance in vaseline. Evaluation and scoring of the reactions followed after 24h and 48h. The sensitivity of the strain was checked every six months with Paraphenylene-diamine or Potassium-dichromate. None of the animals showed erythema or oedema after treatment with the test article. Neither toxic symptoms nor deaths occurred in the control and test groups.

 

Discussion

Multiple application of the test substance onto skin did not cause an allergic reaction. Therefore, the test substance is considered to be a non-sensitizer.


Migrated from Short description of key information:
To assess the allergenic potential of the test article in albino guinea pigs the Maximization-Test (OECD guideline 406) was used. None of the animals showed erythema or oedema after treatment with the test article. Therefore, the test substance is considered to be a non-sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
The substance is solid and has a particle size of app. 153 µm. Thus, the test item is not inhalable.

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 or respiratory sensitisation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, 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 as a sensitizer for skin or respiratory system under Regulation (EC) No. 1272/2008.