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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Insufficent documentation

Data source

Referenceopen allclose all

Title:
Updating the maximisation test for identifying contact allergens.
Author:
Kligman, A.M. and Epstein, W.
Year:
1975
Bibliographic source:
Contact Dermatitis, 1, 231 (cited from Opdyke and Letizia 1982)
Report date:
1975
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
Test in volunteers: "Maximisation" test acc. to Kligman 1966
GLP compliance:
no
Type of study:
other: maximization test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylvaleric acid
EC Number:
202-594-9
EC Name:
2-methylvaleric acid
Cas Number:
97-61-0
Molecular formula:
C6H12O2
IUPAC Name:
2-methylpentanoic acid

In vivo test system

Test animals

Species:
human

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
2% in petrolatum
Challengeopen allclose all
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
2% in petrolatum
No. of animals per dose:
25 volunteers

Results and discussion

Any other information on results incl. tables

A concentration of 2 % in petrolatum produced no sensitisation reaction in 25 volunteers.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information