Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitising potential of the test substance was assessed in a GLP compliant study according to OECD guideline 429 and EU method B.42 (BASF, 58V0495/14X434, 2016). Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, three experimental groups of five female CBA/J mice were treated with test substance concentrations of 0.1, 0.5 or 2 % w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (DMF).

Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. The animals showed neither signs of systemic toxicity nor mortality during the course of the study. Redness of the ear skin could not be assessed due to the colour of the test item. A statistically significant or biologically relevant increase in ear weights was not observed in any treated group in comparison to the vehicle control group. Furthermore, for BALB/c mice, a cut-off value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation. None of the indices determined for the test item treated groups reached or exceeded this threshold.

In this study, Stimulation Indices (S.I.) of 1.05, 4.14, and 7.62 were determined with the test item at concentrations of 0.1, 0.5, and 2 % (w/w) in DMF, respectively. A clear dose response was observed.

A statistically significant and biologically relevant increase was observed in DPM value and also in lymph node weight and -cell count in the mid and high dose group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was exceeded in the mid and high dose group (indices of 1.72 and 2.48, respectively).

The test item was found to be a skin sensitizer and an EC3 value of 0.4 % (w/w) was derived.


Migrated from Short description of key information:
The test substance was found to be a skin sensitiser in the LLNA assay with mice (BASF, 58V0495/14X434, 2016).

Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study report.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as skin sensitisating cat. 1A, H317 (may cause an allergic skin reaction) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.