Registration Dossier

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:
other: Annex V
Deviations:
not specified
GLP compliance:
yes
Type of study:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:

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