Registration Dossier

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:
1992-MAR-30 through 1992-APR-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HR 92/600 154
- Physical state: viscous liquid
- Analytical purity: 98.5%

Test animals / tissue source

Species:
rabbit
Strain:
other: Mol: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Moellegard Breeding Centre ApS, Ejby, Lille Skensved, DK
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: singly
- Diet: free access to feed pellet "Altromin 2123"
- Water: free access to water, acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 55 +/-15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required; untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
treated eyes were washed after 24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: treated eyes were washed after instillation of fluorescent dye and prior to eye examination
- Time after start of exposure: 24 hours


SCORING SYSTEM: according to table contained in OECD TG No. 405


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
There was no eye reaction noted in any animal at any time.

Any other information on results incl. tables

 

Rabbit No. 1

 

1 h

24 h F

48 h

72 h

Area opacity

 

0

0

0

0

Cornea

 

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Chemosis

0

0

0

0

Redness

0

0

0

0

Discharge

0

0

0

0

 

Rabbit No. 2

 

1 h

24 h F

48 h

72 h

Area opacity

 

0

0

0

0

Cornea

 

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Chemosis

0

0

0

0

Redness

0

0

0

0

Discharge

0

0

0

0

 

Rabbit No. 3

 

1 h

24 h F

48 h

72 h

Area opacity

 

0

0

0

0

Cornea

 

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Chemosis

0

0

0

0

Redness

0

0

0

0

Discharge

0

0

0

0

 

Rabbit No. 4

 

1 h

24 h F

48 h

72 h

Area opacity

 

0

0

0

0

Cornea

 

0

0

0

0

Iris

 

0

0

0

0

Conjunctiva

Chemosis

0

0

0

0

Redness

0

0

0

0

Discharge

0

0

0

0

 

F= reading after instillation of fluorescent dye

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU