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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions No positive control, basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
No positive control, basic data given
Principles of method if other than guideline:
Local Lymph Node Assay according to Kimber 1989.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/Ca
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: Acetone
Concentration:
3%, 10% and 30%
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS: No Data

MAIN STUDY

- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must not be incompatible with the biological dose response.

TREATMENT PREPARATION AND ADMINISTRATION:
Samples were administered to the dorsum of both ears using a micro-pipette.
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 30%, 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.

Any other information on results incl. tables

Test Concentration

Cpm/Lymph Node (x 10-2)

Test/Control Ratio

Vehicle

0.22

-

3% w/v

0.10

0.45

10% w/v

0.45

2.05

Vehicle

0.47

-

30% w/v

0.57

1.21

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information