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Toxicological information

Skin sensitisation

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The Local Lymph Node Assay: Developments and Applications
Author:
Kimber I. et al.
Year:
1993
Bibliographic source:
Toxicology. 93, 13-31.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
no
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
other: not specified
Concentration:
Not specified
No. of animals per dose:
Not specified
Details on study design:

MAIN STUDY

Mice of CBA/Ca strain receive 3 consecutive daily applications of various concentrations of the test chemical to the dorsum of both ears. Five days following the initiation of exposure both test and control (vehicle-treated) mice are injected intravenously with [3H]thymidine. Animals are sacrificed 5 h later, the draining auricular lymph nodes excised and pooled for each experimental group and a single cell suspension of LNC prepared and processed for/3-scintillation counting. Chemicals are classified as being 'sensitizers' or 'not strong sensitizers' according to the level of [3H]thymidine incorporation recorded.

ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
Local lymph node assay
- Criteria used to consider a positive response:
The criterion for a positive response is that one or more concentrations of a test chemical should elicit a 3-fold or greater increase in isotope incorporation relative to vehicle controls. The choice of a stimulation index of 3 as being discriminatory was originally somewhat arbitrary, but has since been largely borne out by experience.

TREATMENT PREPARATION AND ADMINISTRATION: Not specified

Results and discussion

Positive control results:
Not specified

In vivo (LLNA)

Results
Key result
Parameter:
SI
Value:
>= 3
Remarks on result:
not determinable because of methodological limitations
Remarks:
No other information on test result other than "positive"

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Using the local lymph node assay technique with [3H]thymidine, test substance propyl gallate yielded a positive response (one or more concentrations elicited a 3-fold or greater increase in isotope incorporation relative to vehicle controls).
Executive summary:

Using the local lymph node assay technique with [3H]thymidine in CBA/Ca mice, test substance propyl gallate yielded a positive response, defined as one or more concentrations eliciting a 3-fold or greater increase in isotope incorporation relative to vehicle controls.