Soybean oil, epoxidized, acrylate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June-August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted according to OECD Guideline No. 429 and under GLP.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Species and strain: CBA/J Rj mice
- Source: ELEVAGE JANVIER
Route des Chènes Secs B.P. 4105
53940 LE GENEST-ST-ISLE, France
- Age at study initiation: 11 weeks old
- Weight at study initiation: 20.3 – 22.5 grams
- Housing: Group caging / mice were provided with glass tunnel-tubes. Cage type: Type II. polypropylene/ polycarbonate
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 27 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchange/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From: 20 June 2012 To: 26 June 2012

Vehicle:

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

Concentration:

The Preliminary Irritation/Toxicity Test was performed in CBA/J Rj mice using two doses (test item concentrations of 50 and 25% (w/v)) in the selected vehicle. The observations recorded in the preliminary test suggest that the 50% (w/v) formulation is a suitable maximum dose level for a valid LLNA.

In the main test, groups of four female CBA/J Rj mice were treated with: 50, 25 and 10% (w/v) of the test substance in AOO.

No. of animals per dose:

4 females per dose

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: acetone/olive oil (4:1 v/v) used as vehicle
- Irritation: The Preliminary Irritation/Toxicity Test was performed in CBA/J Rj mice using two doses (test item concentrations of 50 and 25% (w/v)) in the selected vehicle. The observations recorded in the preliminary test suggest that the 50% (w/v) formulation is a suitable maximum dose level for a valid LLNA.

MAIN TEST
TREATMENT PREPARATION AND ADMINISTRATION:
In the main test, groups of four female CBA/J Rj mice were treated with: 50, 25 and 10% (w/v) of the test substance in AOO. The solutions of the test substance were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

α-Hexylcinnamaldehyde (25% (w/v) dissolved in AOO) was used as a positive control. A significant lymphoproliferative response (stimulation index value of 6.8) was noted for the positive control chemical and this result confirmed the validity of the assay.

Parameter:

SI

Remarks on result:

other: Stimulation index values of the test substance were 2.6, 1.0 and 0.4 at treatment concentrations of 50, 25 and 10% (w/v), respectively.

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

Test Group Measured Group No. of DPN Stimulation Name DPM/group DPM Nodes Index Values Background (5 (w/v) % TCA ) 35.5 - Negative control AOO 1891 1855.5 8 231.9 1.0 Epoxidized Soybean Oil Acrylate 50% (w/v) in AOO 4825 4789.5 8 598.7 2.6 Epoxidized Soybean Oil Acrylate 25% (w/v) in AOO 1882 1846.5 8 230.8 1.0 Epoxidized Soybean Oil Acrylate 10% (w/v) in AOO 727 691.5 8 86.4 0.4 Positive control 25 % HCA in AOO 12703 12667.5 8 1583.4 6.8

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance did not have a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.

Executive summary:

The aim of this study was to determine the skin sensitisation potential of test substance following dermal exposure.

The test subtance was soluble in acetone/olive oil (4:1 v/v) (abbreviation: AOO).The test item formed an applicable solution in AOO at 50% (w/v),therefore it was chosen as vehicle for the test. The test item is very viscousliquid at room temperature, which is not applicable undiluted. The Preliminary Irritation/Toxicity Test was performed in CBA/J Rj mice using two doses (test item concentrations of 50 and 25% (w/v)) in the selected vehicle. The observations recorded in the preliminary test suggest that the 50% (w/v) formulation is a suitable maximum dose level for a valid LLNA.

In the main test, groups of four female CBA/J Rj mice were treated with: 50, 25 and 10% (w/v) of the test substance in AOO. The solutions of the test substance were applied on the dorsal surface of ears of experimental animals (25 µl/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (³HTdR) and the values obtained were used to calculate stimulation indices (SI).

No mortality or sign of systemic toxicity or local irritation were observed during the study. No treatment related effects were observed on animal body weights in any treated groups. The observed clinical signs are summarized in Appendix 3. Stimulation index values of the test substance were 2.6, 1.0 and 0.4 at treatment concentrations of 50, 25 and 10% (w/v), respectively.

α-Hexylcinnamaldehyde (25% (w/v) dissolved in AOO) was used as a positive control to demonstrate the appropriate performance of the assay [1]. A significant lymphoproliferative response (stimulation index value of 6.8) was noted for the positive control chemical and this result confirmed the validity of the assay.

In conclusion, under the conditions of the present assay, the test substance did not have a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The test substance did not show any skin sensitising properties in the Local Lymph Node Assay. There is no reason to believe that results obtained in the Local Lymph Node Assay would not be applicable to humans.

Migrated from Short description of key information:
The test substance is not a sensitiser in the Local Lymph Node Assay.

Justification for selection of skin sensitisation endpoint:
There is only one skin sensitisation study available. This study has been conducted according to OECD guideline no. 429 and under GLP.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerge, this will be taken into account.

Migrated from Short description of key information:
There is no relevant information available for respiratory sensitisation.

Justification for classification or non-classification

The test substance is not a sensitiser in the Local Lymph Node Assay. Therefore, there is no need to classifiy the substance for skin sensitisation, according to the Regulation EC 1272/2008 and the Directive 67/584/EEC.