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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:
15 May - 16 Jul 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Physical state: liquid
- Analytical purity: approximately 100%
- Stability under test conditions: stable at storage conditions
- Storage condition of test material: at ambient temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 2693 - 2894 g
- Housing: individually in plastic cages with perforated floors
- Diet: standard animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm)
- Water: tap-water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 60 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
Single eye instillation
Observation period (in vivo):
72 hours (in the absence of any persistent sign of irritation)

Reading time points: 1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
2 out of 3 animals showed only slight swelling of the blood-vessels in the conjunctivae 1 hour after instillation. The effects were fully reversible 24 hours after instillation. The fluorescein analysis 24 hours after instillation did not reveal any epithelial damage.
Other effects:
Signs of systemic intoxication were not observed.

Any other information on results incl. tables

Table 1: Results of eye irritation test

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

Redness

Chemosis

1 / f

1

0

0

1

0

 

24

0

0

0

0

 

48

0

0

0

0

 

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

2 / f

1

0

0

0

0

 

24

0

0

0

0

 

48

0

0

0

0

 

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

3 / f

1

0

0

1

0

 

24

0

0

0

0

 

48

0

0

0

0

 

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

Group mean

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified