Soybean oil, epoxidized, acrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April-May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted according to OECD Guideline No. 402 and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soybean oil, epoxidized, acrylate

EC Number:

294-415-6

EC Name:

Soybean oil, epoxidized, acrylate

Cas Number:

91722-14-4

Molecular formula:

C63H108O15

IUPAC Name:

Soybean oil, epoxidized, acrylate

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Epoxidized Soybean Oil Acrylate
- Substance type: UVCB
- Physical state: yellow viscous liquid
- Analytical purity: 100 %
- Lot/batch No.: S702300037
- Expiration date of the lot/batch: 31 December 2012
- Storage condition of test material: Room temperature (15-25 oC, below 70 RH%)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species and strain: CRL:(WI) rats
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Hygienic level at arrival: SPF
- Hygienic level during the study: Standard housing conditions
- Justification of strain: The Wistar rat is one of the standard rodent species used in acute toxicity studies
- Housing: Individual caging
- Cage type Type II. polypropylene/polycarbonate
- Number of animals: 5 animals/sex
- Sex: Male and female, female rats were nulliparous and non-pregnant.
- Age of animals at study start: Young adult rats
- Body weight range at dosing: Between 209 g and 243 g
- Acclimatization time: 6 days

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

IN-LIFE DATES: From 2 May 2012 to 16 May 2012

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24-hour exposure period. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster.The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.

At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.

Duration of exposure:

The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14 day observation period.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14 day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination performed on all animals at the end of the 2-week observation period (Day 14).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

The rest item did not cause mortality at dose level of 2000 mg/kg bw.

Clinical signs:

other: No clinical signs were observed after the treatment with the test item or during the 14 day observation period.

Gross pathology:

No macroscopic observations were noted at a dose level of 2000 mg/kg bw.

Other findings:

No dermal signs were observed after treatment with the test item during the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test item Epoxidized Soybean Oil Acrylate was found to be greater than 2000 mg/kg body weight in male and female CRL:(WI) rats.

Executive summary:

An acute dermal toxicity study was performed with test item Epoxidized Soybean Oil Acrylate in CRL:(WI) rats, in compliance with OECD Guideline No.: 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14‑day observation period.

The acute dermal median lethal dose (LD₅₀)of the test item Epoxidized Soybean Oil Acrylate was found to be greater than 2000 mg/kg body weight in male and female CRL:(WI) rats.