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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
not specified

Test material

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
corn oil
Concentration / amount:
concentration of test material:
Intradermal:0.03%
topical:75%
concentration of test material used for each challenge:
topical:75% and 30%
topical: 30% and 10%
Challengeopen allclose all
Route:
other: topical
Vehicle:
corn oil
Concentration / amount:
concentration of test material:
Intradermal:0.03%
topical:75%
concentration of test material used for each challenge:
topical:75% and 30%
topical: 30% and 10%
No. of animals per dose:
20
Positive control substance(s):
no
Remarks:
10 animals - negative control

Results and discussion

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test:75%

Signs of irritation during induction: none

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not classified