Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)

Data source

Reference
Reference Type:
review article or handbook
Title:
Patty's Industrial Hygiene and Toxicology
Author:
Rowe and McCollister
Year:
1982
Bibliographic source:
Clayton and Clayton (eds.), Vol.2C, 3rd ed. (1982), John Wiley & Sons, New York, 4604 - 4605, 4608, 4701

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Sensitization test according to Maguire (modified)
GLP compliance:
not specified
Type of study:
other: Maguire method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-2-ol
EC Number:
200-908-9
EC Name:
2-methylbutan-2-ol
Cas Number:
75-85-4
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-2-ol

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Vehicle:
no data
Concentration / amount:
undiluted
Challengeopen allclose all
Vehicle:
no data
Concentration / amount:
undiluted
No. of animals per dose:
10 animals
Positive control substance(s):
yes
Remarks:
Positive control group

Results and discussion

Positive control results:
All 10 animals showed sensitizing effects

Any other information on results incl. tables

When a group of 10 animals was tested with undiluted test substance none was sensitized (whereas all 10 of positive control group were sensitized).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study the test item is not a skin sensitiser.
Executive summary:

The skin sensitizing potential of the test item was determined. A group of 10 guinea pigs was tested with undiluted test substance. No sensitizing effects were observed. All 10 animals in the positive group showed sensitizing effects.