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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 10 to 24 May 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch No.: Not specified
Purity: ≥99.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Animal 2711 from Broekman Institute, Someren, The Netherlands. Animals 2717 and 2737 from Charles River Wiga, Sulzfeld, West-Germany.
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2654-3179 grams
- Housing: Individually in cages with perforated floors and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): Pelleted standard rabbit maintenance diet approx. 100 g per day.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: At least five days under test conditions for animal 2711, four days for animal 2737 and two days for animal 2717.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3℃
- Humidity (%): 30-83%
- Air changes (per hr): 7.5-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ±60 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Draize scale

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:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2.44
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The test substance appeared to be mildly irritating (M2) to the rabbit eye (Kay and Calandra interpretation of the Draize score: 9.3).

Instillation of the substance into one of the eyes of each of three albino rabbits affected the conjunctivae. The irritation of the conjunctivae was reversible within 14 days.

Treatment of the eyes with fluorescein 2%, 24 hours after test article instillation revealed no corneal epithelial damage in any of the animals.

No corrosion was observed.
Other effects:
No staining by the test article was observed.
No toxic symptoms were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Individual eye irritation scores

Animal

Time after application

Cornea opacity

Iris

Conjunctivae

Redness

Chemosis

2711

1 hour

24 hours

48 hours

72 hours

7 days

14 days

0

0

0

0

0

0

1

0

0

0

0

0

1

2

3

3

2

0

1

1

1

0

0

0

2717

1 hour

24 hours

48 hours

72 hours

7 days

14 days

0

0

0

0

0

0

0

0

0

0

0

0

2

2

3

3

2

0

2

1

1

0

0

0

2737

1 hour

24 hours

48 hours

72 hours

7 days

14 days

0

0

0

0

0

0

0

0

0

0

0

0

1

2

2

2

1

0

1

1

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is mildly irritating to the rabbit eye, sufficient to warrant classification as Category 2 (Reversible eye effects).
Executive summary:

This study was conducted under GLP according to OECD 405. Three rabbits were exposed to 60 mg of the test substance, by instilling the test substance into the eye. The eyes of each animal were examined approx. 1, 24 ,48 and 72 hours, and 7 and 14 days after instillation of the test article.

Under the conditions of this study, the test substance resulted in adverse effects on the conjunctivae. The irritation of the conjunctivae was reversible within 14 days. No corrosion nor signs of systemic intoxication were observed. The test article should be considered mildly irritating to the rabbit eye.