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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The study was conducted in accordance with OECD guideline 404 for testing of chemicals (May 12th, 1981).
Mean irritation scores were calculated according to 83/467/EEC criteria (July 29th, 1983). For calculation of the means of erythema and edema only the readings of 24, 48, and 72 hours were used.

GLP compliance:

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): Vitamin E acetate
- Lot/batch No.: batch no. 7459
No further data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Savo Med. Versuchstierzuchten GmbH, Kisslegg (Germany)
- Age at study initiation: no data
- Weight at study initiation: 2.47 kg (male) 2.25 kg (male) and 2.40 kg (female
- Housing: individually in cages without bedding
- Diet: Kliba 341, ca. 130 g/day
- Water: tap water, ca. 250 ml/day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
The rabbits were identified by ear tattoo.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (6.00-18.00 h/18.00-6.00 h)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of same animals served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 males, 1 female)

Details on study design:

The fur of each rabbit was clipped at least 15 hours prior to the start of the study.

TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: no data
- Type of wrap if used: Test patches (size: 2.5 cm x 2.5 cm) were secured in position with a porous dressing (4 layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Draize scores: 30-60 minutes after removal of the test patches and at 24, 48, and 72 hours after beginning of application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test substance was not irritating. Mean score was 0.0 for both erythema and edema.
Very slight (grade 1) erythema was observed in 3/3 rabbits at the 4-hour reading. The skin of all animals was normal at the 24-hour reading and later.

Other effects:

none

Any other information on results incl. tables

Draize scores:

Reading	Animal no.	Erythema	Edema
4 h	1 2 3	1 1 1	0 0 0
24 h	1 2 3	0 0 0	0 0 0
48 h	1 2 3	0 0 0	0 0 0
72 h	1 2 3	0 0 0	0 0 0
mean individual score	1 2 3	0.0 0.0 0.0	0.0 0.0 0.0
total mean score (mean of 3)		0.0	0.0

No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

The test substance was not irritating under the conditions of this test.

Executive summary:

Three Vienna White rabbits were applied the undiluted test substance for 4 hours in accordance with OECD guideline 404. The test substance was not a skin irritant.