Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study summary report
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS pag 35-36

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
1st: Induction 50 % occlusive epicutaneous
2nd: Challenge 1 % occlusive epicutaneous
3rd:
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
1st: Induction 50 % occlusive epicutaneous
2nd: Challenge 1 % occlusive epicutaneous
3rd:
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: The results are explained in Any other information on results
Remarks on result:
other: Reading:

Any other information on results incl. tables

The criteria used to evaluate the responses are described in the report as follows: Determination of sensitization was based upon reactions to the challenge dose. Grades of 1 or greater in the test animals indicate evidence of sensitization, provided grades of less than 1 are seen in the naive controls. If grades of 1 or greater are noted in the naive control animals, then the reactions of test animals that exceed the most severe naive control reaction are considered sensitization reactions.

One animal had a score of 0.5 after challenge with test substance. In contrast, all the positive control animals were sensitized by their treatment. The sample of test substance was therefore non sensitizing.

Applicant's summary and conclusion