[No public or meaningful name is available]

Skin sensitisation

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:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Significant methological deficiencies (only basic study data reported, no positive control, only 2 concentrations tested, test substance not defined).

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

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

(only basic study data reported, no positive control, only 2 concentrations tested, test substance not defined)

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-10, esters with pentaerythritol

EC Number:

270-291-9

EC Name:

Fatty acids, C5-10, esters with pentaerythritol

Cas Number:

68424-31-7

Molecular formula:

C25H44O8 to C45H84O8

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

No Data

Study design: in vivo (LLNA)

Vehicle:

other: Acetone

Concentration:

3% or 10%

No. of animals per dose:

4

Details on study design:

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 be compatible with the biological dose response.

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 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)

Results

Results 1

Parameter:

SI

Remarks on result:

other: The stimulation index was 3.13 for the 3% application and 6.87 for the 10% application.

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: A significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) increased dose-dependently from 0.0015 Cpm (Vehicle) to 0.0047 and 0.0103 for 3% and 10%, respectively.

Any other information on results incl. tables

Table 1: Results of the ß-scintillation counting

Test Concentration	Cpm/Lymph Node (x 10^-2)	Test/Control Ratio
Vehicle	0.15	-
3% w/v	0.47	3.13
10% w/v	1.03	6.87

The increase in radioactive counts/lymph node seen between vehicle and 3% and 10% of the test compound implies a sensitizing potential. Only two concentrations were tested preventing a conclusive interpretation.

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: EU