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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
Deviations:
not specified
GLP compliance:
yes
Type of study:
not specified

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

In vivo test system

Test animals

Species:
other: unknown
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: unknown
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
other: unknown
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
no data

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: no data
Remarks on result:
other: Reading: other: no data.

Any other information on results incl. tables

The 'Dose level' and the 'No. with + reactions' cannot be provided because the NONS file (provided by ECHA) doesn`t contain this information.

One animal in the control group spontaneously died on day 9. The French c.a. considers that 25% should have been chosen as the induction concentration; however one animal had a very slight skin reaction at 10% therefore the test was accepted .

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not classified as a skin sensitiser