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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 August 1998 - 16 August 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ARAKAWA KE-604
- Physical state: pale yellow blocks
- Analytical purity: no data
- Lot/batch No.: R61132
- 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
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.50 - 2.73 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): mains drinking water
- Water (e.g. ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 65-74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

EXPERIMENTAL DATES: The study was performed between 06 August 1998 and 16 August 1998.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test material was found to weigh approximately 90 mg
(as measured by gently compacting the required volume into an adapted syringe)
Duration of treatment / exposure:
single application
Observation period (in vivo):
first animal: 7 days
2nd and 3rd animal: 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE:
The test substance was not washed out.

SCORING SYSTEM:
According to Draize J H, 1977, "Dermal and Eye Toxicity Tests" in : Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 31.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean of
Time point:
other: 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean of
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
A dulling of the normal lustre of the corneal surface was noted in one treated eye at th 1-hour observation. Diffuse corneal opacity was noted in two treated eyes at the 24 and 48-hour observations and in one treated eye at the 72-hour observation.
Iridial inflammation (grade 1) was noted in two treated eyes at the 1-hour observation and persisted in one treated eye at the 24 and 48-hour observation.
Moderate to severe conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal to moderate conjunctival irritation apparent at the 24 and 48-hour observations. Minimal conjunctival redness was noted in one treated eye at the 72-hour observation. Treated eyes appeared normal 72 hours or 7 days after treatment.
Other effects:
No other effects reported.

Any other information on results incl. tables

Table 1: Results of eye irritation test

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

Redness

Chemosis

1 / m

1

d

1

2

3

 

24

1

1

2

2

 

48

1

1

2

2

 

72

1

0

1

0

 

168

0

0

0

0

Mean (24, 48, 72 h)

1.0

0.7

1.7

1.3

2 / m

1

0

0

2

2

 

24

0

0

1

1

 

48

0

0

1

0

 

72

0

0

0

0

Mean (24, 48, 72 h)

0.0

0.0

0.7

0.3

3 / f

1

0

1

2

2

 

24

1

0

2

2

 

48

1

0

1

1

 

72

0

0

0

0

Mean (24, 48, 72 h)

0.7

0.0

1.0

1.0

Group mean

0.6

0.2

1.1

0.9

 d = dulling of the normal lustre of the cornea

Summary:

In an eye irritation study performed according to OECD Guideline 405, 0.1 mL (90 mg) of the undiluted test substance ARAKAWA KE-604 was instilled into the conjunctival sac of one eye of three male young adult New Zealand White rabbits. The animals were observed for up to 7 days. Irritation was scored according to the method of Draize.

A dulling of the normal lustre of the corneal surface was noted in one treated eye at th 1-hour observation. Diffuse corneal opacity was noted in two treated eyes at the 24 and 48-hour observations and in one treated eye at the 72-hour observation. Iridial inflammation (grade 1) was noted in two treated eyes at the 1-hour observation and persisted in one treated eye at the 24 and 48-hour observation. Moderate to severe conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal to moderate conjunctival irritation apparent at the 24 and 48-hour observations. Minimal conjunctival redness was noted in one treated eye at the 72-hour observation. All treated eyes appeared normal 72 hours or 7 days after treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information No classification is needed according to EU classification criteria. Criteria used for interpretation of results: EU