Registration Dossier

Administrative data

Description of key information

No skin sensitising effects were observed in a Buehler test according to OECD guideline 406 (BASG SE, 32H0567/14X342, 2015).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The dermal sensitizing potential of the test substance was investigated on the basis of the methods of the OECD Guideline 406 (1992), the council regulation (EC) No 440/2008 part B.6. (2008) and the U.S. EPA guideline OPPTS 870.2600 (2003) (BASF SE, 32H0567/14X342, 2015). The test developed by Buehler (1965) and known as Buehler test was used.

The main study was performed on 30 guinea pigs in total. A control group of 10 animals and a test group of 20 animals were formed. The test concentrations for the main study were selected based on the results of a preliminary investigation.

The main study started with an induction phase including an occlusive patch topical application for 6 hours once a week for three consecutive weeks. The animals of the test group (group 2) were induced with the 50 % (w/w) test item in 1 % (w/w) carboxymethylcellulose sodium salt (CMC), whereas the animals of the control group (group 1) were induced with 1 % (w/w) CMC only.

None of the animals of the control group and the test group showed signs of skin irritation during the induction phase.

Four weeks after the first induction, the 6-hour challenge procedure followed by an occlusive topical application of the test item on the right flank of all animals. The skin reactions were evaluated 24 hours and 48 hours after the challenge application. For the challenge, the test item was used in a concentration of 50 % (w/w) in 1 % CMC (w/w). None of the animals of the test group and the control group responded with skin reactions to the challenge treatment with the test item and the vehicle.

Due to the absence of positive skin reactions in the test group (0 %, 0/20) compared to the control group being free of any reactions, a sensitization potential of the test item has not been shown in the challenge. A rechallenge was not required by the sponsor.

Under the experimental conditions described in this report, the test item did not supply evidences for delayed contact hypersensitivity. Based on the results of the non-adjuvant sensitization study described in this final report, the test item did not show a skin sensitizing potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study data and taking into account the provisions laid down in Regulation (EC) No 1272/2008 as amended for the ninth time in Regulation (EU) No 2016/1179, the test substance does not need to be classified as skin sensitising.