Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 OECD Guideline No. 406 "Skin Sensitisation" and Method B6 Acute Toxicity (Skin sensitisation) of Commission Directive 96/54/EC.

The concentrations of test material for the topical induction and topical challenge phases were selected as:

Intradermal Induction: 100%

Topical Induction: 100%

Topical Challenge: 100% and 50% in liquid paraffin.

Skin Reactions Observed After Topical Challenge

100%

No skin reactions were noted at the topical challenge site of the test or control group animals at the 24 and 48 -hour observations.

50% in liquid paraffin

No skin reactions were noted at the topical challenge site of the test or control group animals at the 24 and 48 -hour observations.

The test material produced a 0% sensitisation rate.


Migrated from Short description of key information:
Under the conditions of the test, the test material produced a 0% sensitisation rate and was classified as a non-sensitiser to guinea pig skin.

Justification for classification or non-classification

Skin Sensitisation:

Under the conditions of the test, the test material produced a 0% sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to Regulation 1272/2008/EC.