Fatty acids, C16-18, esters with pentaerythritol

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:

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

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

Test material information

Constituent 1

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)

Results

Results 1

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.

Results 2

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