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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted similar to OECD Guideline 402, but not under GLP. Report is well documented, and the design is considered scientifically accepted.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not relevant

GLP compliance:

no

Remarks:

but with Quality Assurance Unit Statement

Test type:

standard acute method

Limit test:

no

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): dl-alpha-tocopheryl-acetate
- Physical state: liquid

Test animals

Species:

rat

Strain:

other: Albino - SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Füllinsdorf
- Weight at study initiation:
Males: 230.40 +/- 7.42 g
Females: 197.67 +/- 6.40 g
- Housing: Individually in metal cages
- Diet: Ad libitum, Nafag 850
- Water: Ad libitum, tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 10

Administration / exposure

Type of coverage:

occlusive

Vehicle:

vegetable oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: 10% (16 cm²)
- Type of wrap: Gauze and Pergamine paper + occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Luke warm water
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

1000 and 3000 mg/kg (= pure substance)

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: almost once daily
- Necropsy of survivors performed: yes

Statistics:

Not relevant

Results and discussion

Preliminary study:

Not relevant

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Remarks on result:

other: Maximum dosable concentration was limited by the volume of the substance (maximum volume reached at 3000 mg/kg bw)

Mortality:

No mortalities were recorded during the observation period

Clinical signs:

other: Treated animals showed only few signs of skin irritation which appeared 24 - 48 hours after dermal exposure. Erythemas were of low grade (maximum l), and only 2 males (3000 mg/kg) and 3 females (1 with 1000 mg/kg and 2 with 3000 mg/kg) showed signs of sli

Gross pathology:

No abnormalities

Other findings:

Not reported

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Substance is not classified according to EU criteria (67/548/EEG) as the LD50 >3000 mg/kg. Only minor effects on weight and skin have been
observed.

Executive summary:

D, L- alpha-Tocopheryl acetate, which is a derivative of Vitamine E, has been tested in an acute dermal toxicity test (similar to OECD 402, test system: Rat).

A maximum dosis of 3000 mg/kg was applied as the pure substance, which is a viscous oil. A low dosis of 1000 mg/kg was a mixture of the substance with a vegetable oil. This same oil was applied in control groups.

No dermal LD50 could be achieved up to 3000 mg/kg, since no mortality occured.

The test substance causes only slight local erythemas which appear 24 - 48 hours after application. Only few animals showed signs of local abrasion. Female animals are slightly more sensitive to treatment than male animals. Bodyweights were reduced in all groups after the initial 24 h application period. In male groups further weight development was normal. For treated females a slight retardation of weight gain was evident during the first week of the observation period. Final autopsies showed no abnormalities that could be related to treatment.