Soybean oil, epoxidized, acrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been conducted according to OECD guideline No. 423 and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class 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): SAT 010416 (PHOTOMER 3005 F)
- Substance type: UVCB
- Physical state: amber, middle-viscous liquid
- Analytical purity: 100%
- Impurities (identity and concentrations):
- Lot/batch No.: 9829547285
- Expiration date of the lot/batch: 21 May 2001
- Storage condition of test material: room tenperature, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF Wistar rats, stock Shoe WIST, Tierzucht Schönwalde GmbH, Germany
- Age at study initiation: no data
- Weight at study initiation: 142-178 g
- Fasting period before study: approximately 18 hours before dosing
- Housing: in transparent, polycarbonate cages
- Diet (e.g. ad libitum): pelleted, complete rodet diet "Altromin 1314"
- Water (e.g. ad libitum): domestic quality drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hours light

IN-LIFE DATES: From: To: 2 July - 20 July 2001

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg b.w.

Doses:

5000 mg/kg

No. of animals per sex per dose:

3 males, 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 3 and 6 hours after administration and thereafter daily for 14 days
- Frequency of observations and weighing: body weight was recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes, gross necroscy
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: not applicable

Mortality:

No mortailty and no marked signs of toxicity were observed.

Clinical signs:

other: All 3 male rats showed a pinched abdomen and piloerection 1 and 3 hours after application of the test substance. Piloerection was still seen after 6 hour and 1 day after dosing. From day 2 until the end of the observation period no abnormalities were reve

Gross pathology:

At gross necropsy of the animals no pathological abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions described in the report, the oral LD50 of the test substance in rats was higher than 5000 mg/kg b.w.

Executive summary:

The acute oral toxicity of the test substance (SAT 01416) was determined according to the OECD guideline No. 423 "Acute Oral Toxicity - Acute Tox Class Method". The study was conducted with one group consisting of 3 male an 3 female rats, which were given a dose of 5000 mg/kg b.w.

No mortality was observed in the study. Clinical signs were diarrhoea, pinched abdomen and piloerection during the first day after dosing. Under the experimental conditions described in the report, the oral LD50 of the test substance in rats was higher than 5000 mg/kg b.w.