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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:

The Key study was performed on an analog substance according to Magnusson-Kligman Maximization Assay,

Induction phase

The assays are run by applying a minimally irritating dose of the test compound (5% propylene glycol and freund's adjuvant) the to the shaved flanks of Dunkin-Hartley guinea pigs for approximately 3 weeks.

Challenge phase

About 1x week after the last application, the undiluted chemical or 50% in petrolatum is re-applied to the animals.

Scoring of erythema and edema (24 and 48 hours) is accomplished by adding up all the animals that responded in a group of ten and expressing it as a percentage (incidence) and determined the intensity of teach response on a scale of 0-4.

Result

Scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the guinea pig.


Migrated from Short description of key information:
The Key study was performed on an analog substance according to Magnusson-Kligman Maximization Assay. Scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the guinea pig.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin sensitisation.