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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:
01 July - 04 July 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
(no anaesthetics were used, no initial test using one animal was performed)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 Apr 2002
Deviations:
yes
Remarks:
no anaesthetics were used, no initial test using one animal was performed
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a cold dark place (prefabricated refrigerator, 8.6 to 11.4°C), protected from light, in a well-closed container.
- Stability of test article: stable for one year, at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Kbl:NZW [SPF]
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd., Ina, Japan
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.15 - 2.47 kg
- Housing: individual in cages, feeders were changed every week
- Diet: commercial diet RC4 (lot No. 140109, Oriental Yeast), ad libitum
- Water: tap water, ad libitum (analysis was performed)
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 - 22.4
- Humidity (%): 52 - 64
- Air changes (per hr): ≥ 8
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 01 July To: 04 July 2014

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein sodium solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 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
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
1 h after test substance application all animals showed conjunctival redness scored with grade 1 which was fully reversible at the 72 h reading time point in all animals. Furthermore, two animals showed chemosis scored with grade 1, which was still visible in 1/3 animals at the 24 h reading time point. Afterwards, no chemosis was observed in any animal.
The examination for corneal injury using sodium fluorescein solution revealed no lesions in any of the animals at any timepoints.
Other effects:
Clinicle signs
The observation of the general condition didn't disclose any abnormalities in any of the animals throughout the observation period.

Body weights
All of the animals gained body weight during the study.

Any other information on results incl. tables

Table 1: Individual scores of eye irritation

Rabbit #

Time [h]

conjunctivae

iris

cornea

redness

chemosis (swelling)

1

1

1

1

0

0

24

1

1

0

0

48

1

0

0

0

72

0

0

0

0

average

0.7

0.3

0.0

0.0

2

1

1

0

0

0

24

1

0

0

0

48

1

0

0

0

72

0

0

0

0

average

0.7

0.0

0.0

0.0

3

1

1

1

0

0

24

1

0

0

0

48

1

0

0

0

72

0

0

0

0

average

0.7

0.0

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
CLP: not classified