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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
Study period:
From 17 March, 1987 to 24 March, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

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
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test substance (as cited in study report): FAT 40045/C
- Physical state: Powder
- Analytical purity: 100%
- Physical properties: solubility in water: 100 g/L at 20°C; pH: 6.2 (1 g/L water)
- Batch No.: EN 19609.62
- Expiration date of the batch: December 1987
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: Approx. 12 to 14 weeks
- Weight at study initiation: 2390 to 2540 g
- Housing: The animals were housed individually in metal cages
- Diet: Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

IN-LIFE DATES: From March 17, 1987 to March 24, 1987

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL (49 mg)
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3 females
Details on study design:
Prior to test substance instillation, the animals were physically examined to ensure normal ocular surface integrity.

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: Slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
In all animals slight blue staining (test substance related) in the cornea was found which impeded 1 h observation of conjunctival redness.
Other effects:
There were no signs of body weight variability, toxicity or mortality in any animal during the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to be not irritating to the eye.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance (of 100 % purity) to the eyes of New Zealand White rabbits according to OECD Guideline 405. A single ocular dose of 0.1 mL (49 mg) of test substance was applied into the conjunctival sac of right eye of each animal. The eyelids were then gently held together for one sec before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48 and 72 h and 7 d post-instillation. Instillation of the test substance into the eye elicited mild conjunctival redness and chemosis. However, the mean scores of 24, 48 and 72 h in all the animals were below the threshold of significance (<2) and had resolved within 72 h after instillation. Based on these findings, the test substance was considered to be not irritating to the eye.