Soybean oil, epoxidized, ether with ethylene glycol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted prior to introduction of test guidelines or adoption of GLP, however he testin laboratory is reputable and the study design appears to follow methods similar to those adopted subsequently as international standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1955

Report date:

1955

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Similar to OECD Guideline 402 or EC Method 403 but as a rangefinding test fewer rabbits used than recommended in formal guidelines adopted many years after study conduct.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soybean Oil Epoxide

IUPAC Name:

Soybean Oil Epoxide

Details on test material:

Liquid. Used undiluted. A pint of material was supplied from Run No.4, code 272, R.D. 82 on 19 August 1955.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: 3-5 months old
- Weight at study initiation: mean weight 2.5 kg
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Rockland rabbit ration
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From:No details provided To: No details provided

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Impervious 'Vinylite' sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Exposure period was 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 ml/kg bw applied undiluted
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 hour occluded exposure

Doses:

20 ml/kg bw

No. of animals per sex per dose:

NOt stated, but report wording suggests only four rabbits were treated

Control animals:

not specified

Details on study design:

No further details available

Statistics:

Thompson's method for calculating median lethal doses, used where appropriate

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Mortality:

Four rabbits survived treatment at 20 ml/kg bw. It appears that only four rabbits were treated and therefore there were no mortalities.

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

Topical application of 20 ml/kg bw to rabbit skin under fully occluded conditions for 24 hours, resulted in no deaths. All four treated rabbits survived 24 h treatment and the 13 day observation period

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

24 hour exposure to undiluted ESBO under fully occluded conditions did not result in signs of reaction to treatment, mortality or evidence of dermal toxicity in the four rabbits tested.

Executive summary:

The acute dermal LD50 of the read-across substance ESBO (epoxidised soybean oil) was reported to be >20 mL/kg bw in the rabbit.