Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

A guinea pig maximization test was performed comparable to OECD guideline 406 and according to GLP requirements (BASF AG 1991). 10 Dunkin Hartley guinea pigs were used in the treatment group and 5 test animals were used in the control groups (a second control group for a second challenge was not needed due to unambiguous results of the first challenge). Based on a pretest, following concentrations for induction and the challenge were selected:

Intradermal induction: 5% in olive oil DAB 9 or FCA

Percutaneous induction: 50% in olive oil DAB 9

Percutaneous Challenge: 25% in olive oil DAB 9

Following effects were observed: After intradermal induction well-defined erythema and slight edema were observed at the injection sites of the control and test animals, at which only Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) was applied. Injection of the test substance in olive oil DAB 9 resp. in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) caused well-defined derythema and slight edema in the test animals. The control animals injected with olive oil DAB 9 (vehicle) showed well-defined erythema. After percutaneous induction incrustation partially open (caused by the intradermal induction) in addition to well-defined erythema and slight edema were observed in the test and control animals.

After the challenge with the 25% test substance preparation in olive oil DAB 9 six out of nine test animals showed very slight erythema. The animals of control group 1 did not show any skin reactions. Olive oil DAB 9 applied as a vehicle did not cause any skin reactions neither in the test animals nor in the animals of control groups 1 and 2. Keroflux ES 3241 has therefore to be considered as skin sensitiser.


Migrated from Short description of key information:
Guinea Pig Maximization Test: sensitising (GLP, comp. to OECD 406; BASF AG 1991)

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data


Migrated from Short description of key information:
no data

Justification for classification or non-classification

Following the conditions and results of the available test, Keroflux Es 3241 has to be classified with R43 and skin sensitising Cat. 1 according to EEC/67/548 and UN-GHS requirements, respectively.