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:

Introduction: The study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The method was designed to meet the requirements of the following:

-       OECD Guidelines for the testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17th of July 1992)

-       Method B6 Acute Toxicity (Skin Sensitisation) of Commission Directive 96/54/EC

Method: Ten test and five control animals were used for the main study. Two phases were involved in the main test; an induction of a response by intradermal injection and a topical challenge of that response.

Based on the results of sighting tests, the concentrations of test material for the topical induction and topical challenge phases were selected as:

Intradermal Induction:       100%

Topical Induction:        100%

Topical challenge:        12.5% and 6.25% in liquid paraffin

Conclusion: Under the conditions of the test, the test material produced a 0% sensitisation rate and was classified as a non sensitiser to the guinea pig skin . The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrases are required.


Migrated from Short description of key information:
The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrases are required.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
Study not required

Justification for classification or non-classification

The substance Enordet 0241 does not meet the classification criteria according to DSD or the CLP regulations for skin sensitisation and is therefore not classified.