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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 23rd December 1998 to 24th March 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: pale yellow liquid
- Storage condition of test material: The test substance was stored at room 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: B&K Universal G.J., S.L.
- Age at study initiation: 10-11 week old
- Weight at study initiation: 2.6-3.0 kg
- Housing: The rabbits were housed individually in stainless steel cages with a grille floor (48 x 595 x 37 cm), placed on racks.
- Diet (e.g. ad libitum): standard rabbit diet UAR 112, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 21st December 1998 To: 25th January 1999

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
1, 24, 48 and 72 hours, 7 and 14 day after treatment
Number of animals or in vitro replicates:
Three animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was done

SCORING SYSTEM:
Cornea: Opacity:
- No ulceration or opacity 0
- Scattered or diffuse areas of opacity, details of iris clearly visible 1
- Easily discernible translucent area, details of iris slightly obscured 2
- Nacrous area, no details of iris visible, size of pupil barely discernible 3
- Opaque cornea, iris not discernible through the opacity 4

Iris:
- Normal 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reating to light 1
- No reaction to light, haemorrhage, gross destruction 2

Conjunctivae: Redness:
- Blood vessels normal 0
- Some blood vessels definitely hyperaemic 1
- Diffuse, crimson colour, individual vessels not easily discernible 2
- Diffuse beefy red 3

Conjunctivae: Edema:
- No swelling 0
- Slight swelling 1
- Obvious swelling with partial eversion of lids 2
- Swelling with lids about half-closed 3
- Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: Observation of the cornea was completed in each of the readings performed, with the exception of the one done one hour after administration, by applying a 2% aqueous sodium fluorescein solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
In the course of the first hour after instillation, the test substance induced in all the animals, hyperaemia in the palpebral conjunctivae and all the animals presented diffuse, crimson-coloured redness (grade 2) and lacrimation ranging from lacrimation with wetness of the eyelids and adjacent fur to lacrimation affecting a considerable area around the eye. Similarly, two animals presented swelling with lids about half-closed (grade 3) and the remaining animal presented slight swelling (grade 2).
In the reading made 24 hours after application, some blood vessels definitely hyperaemic (grade 1) were recorded in the conjunctivae of all of the animals.
Two of these animals also presented obvious swelling with partial eversion of lids (grade 2).
Some blood vessels were still definitely hyperaemic (grade 1) in one of the animals after 48 hours. In addition, this animal presented slight edema (grade 1) in this reading.
In the subsequent readings, the ocular lesions were noted to have partially remitted.
Other effects:
The behaviour and physical condition of the rabbits were normal throughout the study.

Any other information on results incl. tables

Table 1: Primary eye irritation test

 

Animal

Region of eye

1 h

24 h

48 h

72 h

7 d

14 d

1

Cornea

 

0

0

0

0

0

-

Iris

 

0

0

0

0

0

-

Conjunctivae

Hyperaemia

2

1

0

0

0

-

Conjunctivae

Edema

3

2

0

0

0

-

2

Cornea

 

0

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctivae

Hyperaemia

2

1

0

1

1

0

Conjunctivae

Edema

2

0

0

0

0

0

3

Cornea

 

0

0

0

0

0

-

Iris

 

0

0

0

0

0

-

Conjunctivae

Hyperaemia

2

1

1

1

0

-

Conjunctivae

Edema

3

2

1

0

0

-

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered to be non-irritant to the eye.
Executive summary:

The test substance was administered for the study of primary eye irritation. The study was conducted according to EU method B.5 and OECD guideline 405.

In the course of the first hour after instillation, the test substance induced in all the animals, hyperaemia in the palpebral conjunctivae and all the animals presented diffuse, crimson-coloured redness (grade 2) and lacrimation ranging from lacrimation with wetness of the eyelids and adjacent fur to lacrimation affecting a considerable area around the eye. Similarly, two animals presented swelling with lids about half-closed (grade 3) and the remaining animal presented slight swelling (grade 2).

In the reading made 24 hours after application, some blood vessels definitely hyperaemic (grade 1) were recorded in the conjunctivae of all of the animals.

Two of these animals also presented obvious swelling with partial eversion of lids (grade 2).

Some blood vessels were still definitely hyperaemic (grade 1) in one of the animals after 48 hours. In addition, this animal presented slight edema (grade 1) in this reading.

In the subsequent readings, the ocular lesions were noted to have partially remitted.

The mean values at 24, 48 and 72 hours post-administration, for each type of lesion for the three animals were:

- Corneal opacity 0

- Iridal lesions 0

- Hyperaemia 0.67

- Edema 0.56

The substance is considered to be non-irritant to the eye.