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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 - 12 Feb 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
No analytical purity is given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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 (incl. certificate)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

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
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.53 - 2.95 kg
- Housing: individually housing in suspended cages
- Diet: 2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK: ad libitum
- Water: drinking water; ad libitum
- Acclimation period: att least 5 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated left eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: Examination of the eyes was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 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:
0.3
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:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Ocular Reactions
At 1 h post application, conjunctival redness (score 2) and chemosis (score 1) were noted in all animals. However, the effects were fully reversible within 24 h for chemosis and within 48 h for redness (see table 2). No effects on iris or cornea were observed during the study period.
Other effects:
Body weight
All animals showed expected gain in body weight during the study (table 3).

Any other information on results incl. tables

Table 2. Results of the eye irritation study.

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

redness

swelling

1

 

 

 

 

1

2

1

0

0

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

Time to reversion

48.0

24.0

0.0

0.0

2

 

 

 

 

1

2

1

0

0

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

Time to reversion

48.0

24.0

0.0

0.0

3

 

 

 

 

1

2

1

0

0

 

 

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

Time to reversion

48.0

24.0

0.0

0.0

 

Table 3: Individual body weights and body weight changes

Rabbit Number

Individual body weight [kg]

Body weight change [kg]

Day 0

Day 3

#1

2.95

3.05

0.10

#2

2.82

2.90

0.08

#3

2.53

2.61

0.08

All animals showed expected gain in body weight during the study.

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 according to Regulation (EC) No 1272/2008.