1,2,3-Propanetriol, homopolymer, docosanoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Polyglycerintribehenat

IUPAC Name:

Polyglycerintribehenat

Details on test material:

- Name of test substance: Polyglycerintribehenat
- Physical appearance: solid, waxy, yellowish
- Batch identification: Polyglycerintribehenat (=Entschäumer Hilfsstoff 1 ); Partienummer: 950 vom 19.03.2008
- Expiration date of the lot/batch: 19 Mar 2010
- Purity: The test substance was characterized analytically.
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/J

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: 6 - 12 weeks
- Weight at study initiation: 19.3 - 21.5 g
- Housing: single housing in Makrolon cages, type II
- Diet: Kliba-Labordiät (Maus/Ratte Haltung “GLP”; Provimi Kliba SA, Kaiseraugst, Basel, Switzerland) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

10%

No. of animals per dose:

5

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

- Cell Count Stimulation Index: Vehicle AOO: 1.00; 10% TS in AOO: 0.78 - ³H-thymidine Incorporation Stimulation Index: Vehicle AOO: 1.00; 10% TS in AOO: 0.52 - Lymph Node Weight Stimulation Index: Vehicle AOO: 1.00; 10% TS in AOO: 0.83 - Ear Weight Stimulation Index: Vehicle AOO: 1.00; 10% TS in AOO: 0.94

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Vehicle AOO: DPM/Lymph Node Pair = 1229.1 10% TS in AOO: DPM/Lymph Node Pair = 637.5

Any other information on results incl. tables

Stimulation indices (fold of change as compared to the vehicle control) for cell count, ³H-thymidine incorporation, lymph node weight and ear weight:

Test group	Treatment	Cell Count Stimulation Index	³H-thymidine Incorporation Stimulation Index	Lymph Node Weight Stimulation Index	Ear Weight Stimulation Index
1*	vehicle AOO	1.00	1.00	1.00	1.00
2	10% in AOO	0.76	0.52	0.83	0.94

* Calculation on basis of 4 animals, as one animal died during ³H-thymidine injection.

- Concentration control analysis of the test substance preparation:

No reliable analytical values could be obtained because the acetone in the samples evaporated and the samples became solid at room temperature after freezing. Since essential parts of the samples evaporated, the exact sample weight could not be determined anymore. Therefore the calculation of the content of the test item in the samples could not be performed. From the raw data of substance consumption it is obvious that the right concentration was prepared. Due to the chemical composition of the test substance (fatty acid ester) its stability in the vehicle is expected.

- Body weights:

The expected body weight gain was generally observed in the course of the study.

- Other findings:

No abnormalities were observed during general observation.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

It is concluded that the test substance did not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.

Executive summary:

The skin sensitizing potential of the test substance was assessed using the radioactive Murine Local Lymph Node Assay. The study was performed according to OECD guideline 429 in compliance with GLP.

No signs of systemic toxicity were noticed. When applied as 10% preparation in AOO, the test substance did not induce a biologically relevant response (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. There was no increase in lymph node weights, too. Concomitantly, the increase of ³H-thymidine incorporation into the cells was not biologically relevant (increase above the cut off stimulation index of 3). The test-substance preparation did not cause an increase in ear weights.

Conclusion: It is concluded that the test substance did not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.