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:

Skin sensitisation properties of KBF4 were studied in a GLP-compliant OECD Guideline 429 study with mice (TNO Triskelion BV, 2012). Three test groups of 4 female mice each were treated with 10, 25 and 50% KBF4 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 1356, 1346 and 1235 DPM were found in the auricular lymph nodes of animals treated with respectively 10%, 25% and 50% KBF4 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 KBF4 treated animals compared to controls, were 1.47, 1.46 and 1.34 for the tested doses of 10%, 25% and 50% KBF4, respectively. Since the SI was < 3, the limiting value required for classification as a skin sensitiser, in response to all concentrations of KBF4 tested and no dose response relationship was apparent it was concluded that KBF4 did not have a skin sensitising potential when applied up to concentrations of 50%.

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 the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.