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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:
30 Aug - 03 Sep 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)
Version / remarks:
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:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: individually in PPO cages (floor area: 2576 cm²) with perforated floor
- Diet: Altromin 2123 (Altromin, Lage, Germany), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least one week

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:
yes, concurrent no treatment
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 after treatment
Number of animals or in vitro replicates:
4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL 0.9% sodium chloride solution was used
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein (corneal opacity)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritant / corrosive response data:
One hour after application of the test substance two animals showed some conjunctival vessels definitely injected. Some conjunctival vessels definitely injected and some swelling above normal were seen in one animal. Some conjunctival vessels definitely injected, some swelling above normal and amount of discharge different from normal were observed in one animal. After 24 hours some conjunctival vessels definitely injected were observed in three animals. One animal was free of any signs of eye irritation. After 48 hours some conjunctival vessels definitely injected were observed in one animal. Two animals were free of any signs of eye irritation. After 72 hours all 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

1

0

0

0

24

1

0

0

0

48

1

0

0

0

72

0

0

0

0

Average 24+48+72

0.7

0

0

0

2

1

1

0

0

0

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

1

1

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Average 24+48+72

0

0

0

0

4

1

1

1

0

0

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:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.
Executive summary:

The eye irritation potential of the test substance was investigated in four albino rabbits according to OECD Guideline 405 and in compliance with GLP (1999). 0.1 mL of the test material was placed in the left eye of each animal. The right eye remained untreated and served as control. The eyes were examined and scored according to Draize 1, 24, 48 and 72 hours after application. Conjunctival redness (score 1) was observed in all animals 1 hour after treatment. Additionally, chemosis (score 1) was observed in two animals and discharge (score 1) was noted in one animal 1 hour after treatment. Conjunctival redness (score 1) was noted in three animals at 24 hours and in one animal at 48 hours after application. After 72 hours all animals were free of any signs of eye irritation. The overall mean score after 24, 48 and 72 hours out of four rabbits for conjunctival redness was 0.3. The overall mean irritation score over 24, 48 and 72 hours for chemosis, iris and corneal effects was 0. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.