Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles. The animals were tested for skin and eye irritation at the same time; only 2 animals were used, simultaneously; few details in study report.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in Apr 2002
Deviations:
yes
Remarks:
animals were tested for skin and eye irritation; only 2 animals were exposed; few details in study report
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): [trade name given]
- Physical state: white crystalline powder
- Analytical purity: 100%
- Lot/batch No.: 10SC8156928-2-2

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 21 weeks
- Weight at study initiation: 3.18 - 3.20 kg (range)
- Housing: the animals were individually housed in aluminium suspended cages with stainless steel mesh in the front and floor, w450 x d550 x h350 mm (Yamato Scientific Co., Ltd., Tokyo, Japan). Cages were exchanged with washed, sterile cages every 2 weeks.
- Diet: app. 120 g/day pellet diet for rabbits, LCR-4 (Oriental Yeast Co., Ltd., Japan)
- Water: tap water via automated water supply equipment (Labo Engineering Co. Ltd.,Japan), ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
1 week
Reading time points: 1, 24, 48, 72 and 96 h, and 7 days
Number of animals or in vitro replicates:
2 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
One hour after application, 2/2 rabbits had slight conjunctivae redness (score 1) and moderate chemosis (score 2). At the 24-hours reading time point, moderate conjunctivae redness (score 2) and moderate to severe chemosis (score 2 to 3) were observed in 2/2 animals, and 1 out of 2 rabbits had slight reaction in cornea (score 1). At 48, 72 and 96 reading time points, 2/2 rabbits had slight conjunctivae redness (score 1) and slight chemosis (score 1). All eye irritation effect had cleared within 7-days reading time point. No irritation reactions were observed in the iris.

Any other information on results incl. tables

Table 1: individual irritation scores

 

Time

 

conjunctivae

 

iris

 

cornea

 

 

redness

chemosis

Rabbit 1

1 h

1

2

0

0

 

24 h

2

3

0

1

 

48 h

1

1

0

0

 

72 h

1

1

0

0

 

96 h

1

1

0

0

 

7 days

0

0

0

0

 

Average*

1.33

1.67

0.0

0.33

Rabbit 2

1 h

1

2

0

0

 

24 h

2

2

0

0

 

48 h

1

1

0

0

 

72 h

1

1

0

0

 

96 h

1

1

0

0

 

7 days

0

0

0

0

 

Average*

1.33

1.33

0.0

0.0

* mean of 24 + 48 + 72 h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified