Registration Dossier
Registration Dossier
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EC number: 237-537-7 | CAS number: 13827-02-6
Endpoint summary
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:
In a GLP-compliant OECD Guideline 429 study, skin sensitisation properties of KZnF3 were studied in mice. Three test groups of 4 female mice each were treated with 2.5, 5 and 10% KZnF3 by means of open application of 25 μL to the dorsum of each ear for three consecutive days. Three days after the last treatment, all animals received an intravenous injection of 3H-thymidine. Five hours later, the 3H-thymidine incorporation in the draining auricular lymph nodes was determined. The results were compared with those of a negative control group which was treated with the vehicle (acetone/olive oil, 4:1 v/v). Group mean 3H-thymidine incorporations of 1810, 1118 and 1641 DPM were found in the auricular lymph nodes of animals treated with respectively 2.5%, 5% and 10% KZnF3 formulations. The group mean value in the vehicle control animals was 919 DPM. The calculated stimulation indices (SI), representative of the change in 3H-thymidine incorporation in Nocoloc Zn Flux treated animals compared to controls, were 1.97, 1.22 and 1.78 for the tested doses of 2.5%, 5% and 10% KZnF3, respectively. Since the SI was < 3, the limiting value required for classification as a skin sensitiser, in response to all concentrations of KZnF3 tested and no dose response relationship was apparent it was concluded that KZnF3 did not have a skin sensitising potential when applied up to the maximum technically attainable concentration of 10%.
Migrated from Short description of key information:
Under the experimental conditions of this study, no evidence was obtained that KZnF3 has a skin sensitising potential when applied up to the maximum, technically attainable concentration of 10%.
Justification for selection of skin sensitisation endpoint:
Only study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the findings in the skin sensitisation study, the substance does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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