Registration Dossier
Registration Dossier
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EC number: 221-220-5 | CAS number: 3033-62-3
Endpoint summary
Administrative data
Description of key information
The test item was found to be non-sensitising in two Guinea pig maximization studies (1 key study, 1 supporting study) and a Local Lymph Node Assay in mice. No in vitro studies were performed with this test substance.
No data are available on the respiratory sensitization endpoint for this material.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation - in vivo:
A reliable, GLP-compliant study was conducted in guinea pigs according to OECD Guideline 406 (K1; Pharmakon research International, Inc., 1992). Based upon the observations made in the assay, the test substance induced at 4%, challenged at 2% and rechallenged at 1% did not cause delayed contact hypersensitivity in guinea pigs (n=20, 10 male/10 female). One vehicle control animal died during the study but the death was determined to be due to non-test related factors. Additionally, no sensitization was observed in two supporting, reliable studies (a Local Lymph Node Assay in Balb/c mice and a Guinea pig maximization test).
Skin sensitisation - in vitro:
An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study, initiated before 11 October 2016 are available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data are available on the respiratory sensitization endpoint for this material.
Justification for classification or non-classification
Based on reliable in vivo skin sensitization test results, the test substance does not meet the criteria for classification as a skin sensitizer according to CLP Regulation 1272/2008.
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