α-tocopherol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliable study with limited data on material and method, please refer to IUCLID section 13 for read across justification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only one dose

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Tocopherols

EC Number:

604-195-9

Cas Number:

1406-66-2

Molecular formula:

not applicable

IUPAC Name:

Tocopherols

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): MX 6037; 82-0104
- Lot/batch No.:TWB 1G32
- A.i. concentration: 50%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Weight at study initiation: approximately 200 to 300 g
- Fasting period before study: overnight (approximately 18 hours)
- Housing: individually housed in wire mesh bottom cages in environmenta controlled rooms
- Acclimation period: 3-5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

15000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed prior to dosing and at termination. They were observed frequently on the day of dosing and daily for a total of 15 days. All gross and visible toxic or pharmacological effects were recorded.
- Necropsy of survivors performed: yes (all animals that died during the study)
- Other examinations performed: body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

15 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 7 500 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality occurred.

Clinical signs:

other: In 2 animals diarrhea occurred on day 2 after administration which lasted one day.

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the rat was estimated to be greater than 15000 mg/kg bw. According to the a.i. concentration the LD50 of the a.i. (CAS: 1406-66-2) is calculated to be greater than 7500 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item was investigated in five Sprague-Dawley rats of each sex similar to the OECD guidelines for acute oral toxicity studies (limit test). The rats received a single oral dose of 15000 mg/kg bw. No mortality occurred. Two animals showed diarrhea on day 2.

The acute oral median lethal dose (LD50) of the test item in the rat was estimated to be greater than 15000 mg/kg body weight. The a.i. content was 50% and thus the LD50 of the a.i. (CAS: 1406 -66 -2) was calculated to be greater than 7500 mg/kg bw.