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:

As key study, a guinea pig maximisation test according to OECD TG 406 and GLP was conducted with Uvinul A Plus in olive oil using female Dunkin-Hartley guinea pigs (BASFAG30H0408/992238).

Skin irritation findings were observed in animals of the test groups and the control groups at the injection site following intradermal induction (5% test substance) and later at the same site in the animals of the same groups after the epicutaneous induction (25% test substance). The challenge exposure (24 hours with 25% test substance in olive oil) caused no skin reactions in any of the study animals (test group animals and control group) when evaluated 24 and 48 hours after removal of the patch.

Therefore the test substance Uvinul A Plus was found to have no sensitizing potential.



Migrated from Short description of key information:
A skin sensitization study was conducted (Guinea Pig Maximization Test) with Uvinul A Plus according to the OECD TG 406. The test substance Uvinul A Plus showed no dermal sensitizing effect. No skin reactions were observed in any of the animals of the test group and control group after the challenge treatment with 25% of the test substance in olive oil.

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data available


Migrated from Short description of key information:
no data available

Justification for classification or non-classification

The present data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted.