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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:
12 - 16 Feb 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Jan 1997
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 - 3.3 kg
- Housing: during a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: Altromin 2123 (Altromin 2123, Lage, Germany), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- 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 applied: 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with 20 mL 0.9% sodium chloride solution.
- Time after start of exposure: 24 hours

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:
of 4 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
One hour after application of the test substance 2 animals showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge with moistening of the lids and hairs, and considerable area around the eye. An iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible , a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids were observed in the other 2 animals. 24 hours alter application of the test substance all animals showed some conjunctival vessels definitely injected. 48 and 72 hours after application of the test article all four animals were free of any signs of eye irritation.

Any other information on results incl. tables

Table 1. Results of the eye irritation study

Animal

Time (h)

Conjunctivae

Cornea

Iris

Redness

Chemosis

1

1

2

1

0

1

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

Average 24+48+72

0.3

0

0

0

2

1

2

1

0

1

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

Average 24+48+72

0.3

0

0

0

3

1

2

1

0

1

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

Average 24+48+72

0.3

0

0

0

4

1

2

1

0

1

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

Average 24+48+72

0.3

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.