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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted 24 April 2002)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(Aug 1998)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147 (adopted 2002)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom, London, UK

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 57033
- Expiration date of the lot/batch: 25 November 2014

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
- Details on strain: Hsdlf:NZW
- Source: Harlan Laboratories UK Ltd. Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.33-2.66 kg
- Housing: individually in suspended cages
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: tap 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

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye of the same animal served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
1 single application
Observation period (in vivo):
7 days (reading time points: directly after application, 1, 24, 48, and 72 hours and 7 days thereafter)
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize Scoring System

Additionally, a modified version of the system (Kay and Calandra (1962), J. Soc. Chem. 13: 281-289) was used to classify the ocular irritancy potential of the test item. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The scores for cornea, iris and conjunctivae were calculated as follows:
Conjunctivae total score = (redness score + chemosis score + discharge score) x 2
Iris score = iris score x 5
Cornea score = (degree of opacity x area of cornea involved) x 5

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

OTHER
Body weights were recorded on day 0 and at the end of the observation period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
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 all 3 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: revrsibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of animal #1 and #2
Time point:
other: mean over 24, 48, and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h after treatment: score = 2 in both animals
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h after treatment: score = 2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of animal #1 and #2
Time point:
other: mean over 24, 48, and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h after treatment: score = 2 in both animals
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48, and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 h after treatment: score = 2
Irritant / corrosive response data:
No effects on cornea and iris were observed during the study. All animals showed conjunctival redness and swelling (score = 2) at the 1 h reading. The effects were attenuated within 24 to 72 h and were fully reversible within 72 h in animal #1 and within 7 days in animal #2 and #3.
Other effects:
All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1: Eye irritation – Details on result

Animal #

Time after treatment

Cornea

Iris

Conjunctival redness

Chemosis

Individual total score

#1

1 h

0

0

2

2

17

24 h

0

0

2

2

10

48 h

0

0

1

1

4

72 h

0

0

0

0

0

7 days

-

-

-

-

-

Mean (24-72 h)

0.00

0.00

1.00

1.00

-

#2

1 h

0

0

2

2

17

24 h

0

0

1

1

4

48 h

0

0

1

1

4

72 h

0

0

1

1

4

7 days

0

0

0

0

0

Mean (24-72 h)

0.00

0.00

1.00

1.00

-

#3

1 h

0

0

2

2

10

24 h

0

0

2

2

8

48 h

0

0

2

1

6

72 h

0

0

1

1

4

7 days

0

0

0

0

0

Mean (24-72 h)

0.00

0.00

1.67

1.33

-

Group mean score(24-72 h)

0.00

0.00

1.22

1.11

 

 

 

Group mean total score

1 h

14.7

24 h

7.3

48 h

4.7

72 h

2.7

7 d

0.0

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