Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.