Soybean oil, epoxidized, acrylate

Endpoint summary

Description of key information

The test subtance is not acutely toxic for the oral and dermal route. In both studies, the LD50 is >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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:

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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

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).

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Based on the available information, the acute toxcity of the test substance is low for the oral and dermal route of administration. In both studies, the LD50 is >2000 mg/kg bw. There is no study available for the inhalation route. Even though there is no information on acute toxicity is humans, there is no resaon to believe that the low acute toxicty observed in experimental animals would not be relevant for human health.

Justification for selection of acute toxicity – oral endpoint
Only one acute toxicity study for the oral route is available. The study has been conducted according to OECD guideline 423 and under GLP.

Justification for selection of acute toxicity – dermal endpoint
Only one acute toxicity study for the dermal route is available. The study has been conducted according to OECD guideline 402 and under GLP.

Justification for classification or non-classification

Based on the available data the substance does not need to be classified for acute toxicity, according to the Regulation EC 1272/2008 and the Directive 67/548/EEC.