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:
1997 - 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in accordance with GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
Please refer to the section "confidential details on test material" below.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: DR . K . THOMAE GMBH, Biberach, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: Animal 1: 3.99 kg (female); Animal 2: 3.81 kg (male); Animal 3: 3.85 kg (male)
- Housing: Single housing; stainless steel wire mesh cages with grating, Floor area: 3000 cm², no bedding in the cages, sawdust in the waste trays
- Diet: Kliba-Labordiät, Klingentalmühle AG Kaiseraugst, Switzerland (about 130 g per animal per day
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes (per hr): Fully-air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)

IN-LIFE DATES: From: 1997-01-20/27 To: 1997-02-03/10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
3
Details on study design:
PREPARATION:
- Both eyes of the animal(s) were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.

REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with tap water
- Time after start of exposure: about 24 h after application (before 24 h reading)

SCORING SYSTEM: Draize scale of scoring

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2, 3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: 8 days observation - loss of corneal tissue
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 1 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 8 or 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: eye discharge
Basis:
animal: #1, #2, #3
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
other: eye discharge
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
other: eye discharge
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
other: eye discharge
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
All animals: discharge of blood was observed after 1, 24, 48 and 72 hours
Animal #2 and #3: suppuration was observed also after 48 and 72 hours

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU