3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP near-guideline study, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate

EC Number:

231-710-0

EC Name:

3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate

Cas Number:

7695-91-2

Molecular formula:

C31H52O3

IUPAC Name:

2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-1-benzopyran-6-yl acetate

Details on test material:

- Name of test material (as cited in study report): Vitamin E acetate (DL-alpha-tocopheryl acetate)
- Analytical purity: 98.7%
- Impurities (identity and concentrations): no data
No further data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld (Germany)
- Age at study initiation: no data
- Body Weight: mean body weight after 14 days recovery: males: 240 g , females 210 g
- Fasting period before study: 16 hours
- Housing: no data
- Diet: MRH Kraftfutter (Eggersmann, Rinteln, Germany) ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test substance was emulsified in olive oil to a final concentration of 50% (w/v). Ten male and ten female rats received a single oral bolus of the test substance at 10000 mg/kg bw. After dosing, the animals were observed for 14 days, then sacrificed.
No further data

Doses:

single oral bolus of 10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not exactly defined
- Necropsy of survivors performed: yes
- Examinations performed: mortaltiy, symptoms of intoxication, and necrospsy (after 1, 24, 48 hours and 7, 14 days)
No further data.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Remarks on result:

other: No deaths occurred.

Mortality:

No deaths occurred.

Clinical signs:

other: A slight diarrhea and a slight erythema of the skin was observed at the first day after dosing. No other clinical signs were noted.

Gross pathology:

No pathological changes were noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Executive summary:

The acute oral toxicity of Vitamin E acetate was determined for Sprague-Dawley rats. The test material was applied as a 50% solution in olive oil. The animals received a single application of 10000 mg/kg bw by gavage. The median lethal dose (LD50) was >10000 mg/kg bw for males and females.