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Toxicological information

Skin irritation / corrosion

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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:
guideline study
Remarks:
non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Vitamin E acetate
- Lot/batch No.: batch no. 7459

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Details on test animals 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:
yes, concurrent no treatment
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was not a skin irritant, mean score was 0.0 for both erythema and edema.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404 study. The undiluted test substance was applied to the skin of three Vienna White rabbits for 4 hours. Under the study conditions, the test substance was not a skin irritant, mean score was 0.0 for both erythema and edema (BASF, 1989).