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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study records
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No information
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
Repeated exposure of the substance to the intact skin for 10 treatments, followed by exposure to a previously untreated site after a period of 17 days continuous non-exposure.
GLP compliance:
Type of study:
open epicutaneous test
Justification for non-LLNA method:
The data are historically available data involving exposure to animals, but suitably demonstrates a positive response
guinea pig
not specified
not specified
other: ether
No. of animals per dose:
10 test and 3 control
Key result
Hours after challenge:
test chemical
Dose level:
10% in ether
No. with + reactions:
Total no. in group:
Clinical observations:
blotchy reedness
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
The substance is sensitising under the conditions of the test.
Executive summary:

The sensitising effect of the substance has been assessed by reapeted expsoure of a 10% solutioin in ether exposed to guinea pigs. The test solution has been applied to the intact, naked skin of 10 guiea pigs with ten repeated applications over a period of 5 days. Following a period of 17 days without expsoure to the substance, the test solution was then applied to the naked skin a previously unexposed area of the guiea pigs and the reactions assessed compared to the control animals which were treated only with ether.

In the study 8 of the 10 test animals showed blotchy redness deemed to be a senstising effect of the test substance.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification

Follwoing exposure of a 10% solution of the substance in ether to the skin of 10 guinea pigs, 8 of the 10 test s animals were deemed to display a positive senstising response. It is not possible to distinguish between the category of Class 1 a and Class 1b, so the substance is classified as Sensitising to skin Class 1