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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:
May 2014 - September 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3706OB
- Expiration date of the lot/batch: 01 March 2019
- Purity test date: >99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 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: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.42 to 2.79 kg
- Housing: suspended cages
- Diet / Water: Free access to mains drinking water and food was allowed throughout the study
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test item

VEHICLE
no vehicule
Duration of treatment / exposure:
A single application of the test item
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment; Additional observations were made on Days 7 and 14 to assess the reversibility of the ocular effects.
Duration of post- treatment incubation (in vitro):
14 days
Number of animals or in vitro replicates:
Three animals : 2 females and 1 male

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes 1 hour after treatment, in two treated eyes at the 24-Hour observation and persisted in one treated eye at the 48 and 72-Hour observations.
Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24, 48 and 72-Hour observations. Moderate conjunctival irritation persisted in one treated eye at the 7-Day observation.
Two treated eyes appeared normal at the 7-Day observation and one treated eye appeared normal at the 14-Day observation.
Other effects:
Body Weight : All animals showed expected gain in body weight during the study.


Measurement of pH:
10% w/w aqueous preparation of the test item immediately after preparation = 7.33
10% w/w aqueous preparation of the test item ten minutes after preparation = 7.33

Any other information on results incl. tables

Table 1:    Individual Scores for Ocular Irritation

Rabbit Number and Sex

74530 Female

74607 Female

 74667 Male

IPR = 0

 IPR = 0

 

 IPR = 0

Time After

Treatment

1

Hr

24 Hr

48 Hr

72 Hr

7

Dy

1

Hr

24 Hr

48 Hr

72 Hr

7

Dy

1

Hr

24 Hr

48 Hr

72 Hr

7 Dy

14

Dy

CORNEA

Degree of Opacity

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Area of Cornea

Involved

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

IRIS

1

0

0

0

0

1

1

0

0

0

1

1

1

1

0

0

CONJUNCTIVAE

1 Redness

2

2

1

1

0

2

2

2

2

0

2

2

2

2

2

0

1 Chemosis

2

1

0

0

0

2

2

2

1

0

2

2

2

2

1

0

1 Discharge

1

0

0

0

0

2

3

2

2

0

2

2

2

2

1

0

IPR= Initial Pain Reaction

Hr = Hours

Dy = Day

Table 2:     Individual and Mean Scores for Cornea, Iris and Conjunctivae

Rabbit number and Sex

Time After Treatment

Corneal Opacity

Iridial Inflammation

Conjunctival Redness

Conjunctival Chemosis

74530 Female 

24 Hours

0

0

2

1

 

48 Hours

0

0

1

0  

 

72 Hours

0

0

1

0

Total

 

 

0

0

4

1

Mean

 

 

0.0

0.0

1.3

0.3

74607 Female 

24 Hours

0

1

2

2

 

48 Hours

0

0

2

2

 

72 Hours

0

0

2

1

Total

 

 

0

1

6

5

Mean

 

 

0.0

0.3

2.0+

1.7

74667 Male

24 Hours

0

1

2

2

 

48 Hours

0

1

2

2

 

72 Hours

0

1

2

2

Total

 

 

0

3

6

6

Mean

 

 

0.0

1.0+

2.0+

2.0+

+ = Positive criterion according to CLP/GHS criteria.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Under the experimental conditions of this study and according to the criteria laid down in GHS, the test item is considered as as Irritating to eyes (Category 2A), due to the absence of complete reversibility 7 days following instillation.
Executive summary:

The potential of the test item to induce eye irritation was assessed in New Zealand White rabbit according to the OECD Guidelines for the Testing of Chemicals No.405  "Acute  Eye Irritation/Corrosion".The study was conducted in compliance with the principles of Good Laboratory Practice.

A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation between 1 and 72 hours following dosing and moderate conjunctival irritation between 1 hour and 7 days following dosing. Two treated eyes appeared normal at the 7-Day observation and one treated eye appeared normal at the 14-Day observation.

The test item was classified as Irritating to eyes (Category 2A) according to the Globally Harmonized Classification System.

The Signal Word "Warning" and the Hazard Statement "H319: Causes serious eye irritation" are therefore required.