Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards

Data source

Reference
Reference Type:
publication
Title:
Structure activity relationships in a skin sensitization using the murine local lymph node assay
Author:
Ashby J, Basketter DA, Paton D AND Kimber I
Year:
1995
Bibliographic source:
Toxicology 103: 177-194

Materials and methods

Principles of method if other than guideline:
Proliferation of local lymph node was determined by means of increased 3H-thymidine incorporation. A threefold increase compared with vehicle-treated controls was considered to be determinant of sensitising capacity.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethyl sulfate
No further specification

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No further data

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0.25, 0.5, and 1.0% in acetone/olive oil 80/20 v/v
No. of animals per dose:
number of animals not indicated
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a threefold increase compared with vehicle-treated controls was considered to be determinant of sensitising capacity

TREATMENT PREPARATION AND ADMINISTRATION:
Topical dosing of test substance
Positive control substance(s):
other: 106 chemicals are listed in the evaluation, some of which are known sensitizing agents
Statistics:
topical dosing of test substance (see below)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Ratio of 3H-thymidine incorporation in local lymph nodes of treated vs control animals was reported to be 3.8 (concentration of test substance 0.25%), 6.0 (0.5%), 5.7 (1.0%).
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not specified

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information