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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Age at study initiation: no data
- Weight at study initiation: 3.60 kg (male), 3.55 kg (female) and 3.82 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): 22-24
- 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

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (instilled into the conjunctival sac of the right eye of each of 3 White Vienna rabbits)
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Eyes were not rinsed after instillation.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1 male, 2 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
- Time after start of exposure: not applicable

SCORING SYSTEM:
Draize scores. The eyes were scored at 1, 24, 48, and 72 hours after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
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 cornea, iris, and conjunctival swelling, and 0.2 for conjunctival redness.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, a slight irritation was noted at 1-48 h, the eyes were normal at 72 h.
Executive summary:

A study was conducted to determine the corneal damage potential by the test substance. The undiluted test substance was instilled into the right eye of each of three rabbits. The left eyes remained untreated and served as control. The eyes were scored at 1, 24, 48, and 72 hours after instillation. Under the study conditions, a slight irritation was noted at 1-48 h, the eyes were normal at 72 h (BASF, 1989).