Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In a study performed on the substance under registration the test item suspended in dimethylformamide was assessed for its possible contact allergenic potential, according to the OECD Guideline 429 Skin Sensitisation: Local Lymph Node Assay (adopted 24 April 2002).

For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25 %.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

In this study Stimulation Indices (S.I.) of 0.64, 1.25, and 0.86 were determined with the test item at concentrations of 5, 10, and 25 % in dimethylformamide, respectively. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.


Migrated from Short description of key information:
Not skin sensitising.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact. The criteria to classify a substance as skin sensitizer, on the basis of results from test animals, are reported into the second adaptation to technical progress*: a substance in considered a skin sensitizer when:

- an adjuvant type test method for skin sensitisation is used and a response of at least 30 % of the animals is considered as positive;

- for a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive;

- a stimulation index of three or more is considered a positive response in the local lymph node assay.

In this study Stimulation Indices (S.I.) of 0.64, 1.25, and 0.86 were determined with the test item at concentrations of 5, 10, and 25 % in dimethylformamide, respectively. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.

In conclusion, according to the CLP Regulation (EC 1272/2008), the test substance is classified as not skin sensitizing.

*Commission Regulation (EU) No 286/2011 of 10 March 2011, amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.