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:

The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Hsd Win:NMRI in 6 animals per test item group and 6 control animals to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item. The study was conducted according to OECD guidelienes No. 429 and 406, EC Guideline 96/54/EC, test method B.42, and OPPTS 870.2600 (EPA).

The following test concentrations were applied: 0 (vehicle control), 2, 10, and 50 %. The test item was formulated in dimethylformamide (DMF) to yield a solution.

Compared to vehicle-treated animals, none of the parameters masured in the substance-treated groups, i.e. cell counts and weights of the draining lymph nodes, ear weights and ear swelling, reached or exceeded the "positive levels" defined for this assay. These results show that there is no indication for a skin sensitizing effect after administration of a concentration up to and including 50 % of the test item in this system.

In conclusion, these results show that the test item has no sensitizing potential in mice after dermal application of up to and including a 50 % concentration. No pronounced indication for a non-specific (Irritant) activation was detected, too. Therefore, the concentration of 50 % turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.


Migrated from Short description of key information:
The test item has no sensitizing potential in mice after dermal application of up to and including a 50 % concentration.

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.