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Diss Factsheets

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 Aug. 29, 2000 to Nov. 28, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): FC 84508

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kiβlegg
- Weight at study initiation: 2.3 - 3.9 kg
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: From automatic water dispensers, ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Aug. 29, 2000 To: Sep. 08, 2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h

SCORING SYSTEM: Lesions in cornea, iris or conjunctivae were graded numerically "Scale for scoring ocular reactions"

TOOL USED TO ASSESS SCORE: 0.01 % fluorescein-sodium solution; 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
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- 1 h after administration, the conjunctivae of the animals showed sporadically definitely injected blood vessel and a very slight swelling.
- In addition, serous by compound discolored eye discharge was noted, 24 h after administration.
- All signs of irritation had completely reversed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance was considered to be non-irritating to the rabbit eye
Executive summary:

A study was conducted to assess the eye irritation potential of test substance to the rabbit eye according to EU Method B.5. and OECD Guideline 405 in compliance with GLP.

Three animals received 0.1 g of an undiluted test substance into conjunctival sac of the left eye. The other eyes served as untreated control. 24 h after the administration the eyes were washed thoroughly with isotonic saline at 37 °C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h the eyes were further examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically (Scale for scoring ocular reactions). All other changes or toxic effects were recorded when apparent.

One hour after administration the conjunctivae of the animals showed sporadically definitely injected blood vessel and a very slight swelling. In addition, serous by compound discolored eye discharge was noted, 24 h after administration all signs of irritation had completely reversed.

Based on the individual scores after 24, 48 and 72 h, the mean values were calculated to be ‘0’ for opacity of cornea, iris, redness of the conjunctiva and chemosis of conjunctiva.

Under the test conditions, the test substance was considered to be non-irritating to rabbit eye.