Registration Dossier
Registration Dossier
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EC number: 211-317-0 | CAS number: 638-07-3
Endpoint summary
Administrative data
Description of key information
The test material was examined for possible sensitizing properties by a maximization test in guinea pigs according to OECD no. 406 using 10 test animals and 6 controls.
Test animals were treated as follows:
a) induction: treatment by intradermal injections of Freund's Complete Adjuvant (FCA) 1:1 diluted with isotonic saline, a 0.03% test dilution of test item in maize oil, and a 0.03% test dilution in FCA/diluent 1:1, followed one week later by topical application of a 3% dilution of test item in maize oil
b) challenge: treatment, 14 days after the last induction, by topical application of a 0.3% dilution of terst item in maize oil and with the vehicle alone,
Controls were treated as follows:
a) induction treatment by intradermal injections of FCA,/saline 1:1, maize oil alone, and FCA/diluent 1:1, followed one week later by topical application of the vehicle alone, and
b) challenge treatment, 14 days after the last induction, by topical application of a 0.3% dilution of test item in maize oil and with the vehicle alone.
The challenge treatment with P0026 caused signs of sensitization in six out of ten test animals. On the basis of the results obtained under the conditions of this study and according to the EC-standards, it was concluded that the test substance is a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the two studies, the test item needs to be classified as follows:
Skin sensitization cat.1 - H317: May cause an allergic skin reaction
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