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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:
02 - 10 Jan 2013
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White (Hsdlf:NZW)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.61-2.93 kg
- Housing: The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
single instillation without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
2

Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: ophthalmoscope

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:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Individual scores for ocular irritation are given in Table 1. The individual and mean scores as required for EU and GHS classification and labelling are presented in Table 2.
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes one hour after treatment.
Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one hour after treatment. Minimal conjunctival irritation noted in both treated eyes at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation.
Other effects:
Individual bodyweights and bodyweight changes are given in Table 3.
Both animals showed expected gain in bodyweight during the study.
No further local or systemic effects were observed during the study period.

Any other information on results incl. tables

Table 1. Individual Scores for Ocular Irritation

Rabbit Number and Sex

72824 Male

72839 Male

IPR = 1

IPR =2

Time After Treatment [h]

1

24

48

72

1

24

48

72

CORNEA

Degree of opacity

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

1

0

0

0

CONJUNCTIVAE

Redness

Chemosis

Discharge

 

1

1

1

 

1

1

0

 

0

0

0

 

0

0

0

 

1

2

2

 

1

1

1

 

0

0

0

 

0

0

0

 

IPR = Initial Pain Reaction

 

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

Rabbit Number and Sex

Time After Treatment [h]

Corneal Opacity

Iridial Inflammation

Conjunctival Redness

Conjunctival Chemosis

72824 Male

24

48

72

0

0

0

0

0

0

1

0

0

1

0

0

Mean

0.0

0.0

0.3

0.3

72839 Male

24

48

72

0

0

0

0

0

0

1

0

0

1

0

0

Mean

0.0

0.0

0.3

0.3

 

Table 3. Individual Body Weights and Body Weight Changes

Rabbit Number and Sex

Individual Body Weight (kg)

Body Weight Change (kg)

Day 0

Day 3

72824 Male

2.93

3.00

0.07

72839 Male

2.61

2.68

0.07

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced individual scores of 0/0 for corneal opacity, 0/0 for iritis, 0.3/0.3 for conjunctival redness and 0.3/0.3 for chemosis, calculated as the mean scores following grading at 24, 48 and 72 hour after instillation. Observed effects were fully reversible within the observation period.
Therefore, the test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures and the Globally Harmonised System of Classification and Labelling of Chemicals.
The test item is thus considered to be not irritating to rabbit eyes.

CLP: not classified
GHS: not classified