Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-03-02 to 1987-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

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 animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: not specified
- Weight at study initiation: 2.35 (mean of two males); 2.11 (one female)
- Housing: Stainless steel cage with wire mesh walk floor (floor area: 40 x 51 cm)
- Diet: about 130 g /animal / day
- Water: about 250 mL tap water / animal / day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 1987-03-10 to 1987-03-25 (males) or to 1987-03-23 (female)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: as is (approximately 30% solution in water)
Duration of treatment / exposure:
not applicable (substance was not washed out)
Observation period (in vivo):
maximum observation period: 3 to 15 days (one male died prematurely)
Animal 1 (female, 0685): 15 days
Animal 2 (male, 0665): 15 days
Animal 3 (male, 0663): 48 h
(readings at 1h, 24h, 48h, 72h, 8d and 15d after application, where possible)
Number of animals or in vitro replicates:
3 rabbits (2 males, one female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: eye not washed out

SCORING SYSTEM: Draize Score

TOOL USED TO ASSESS SCORE: not documented

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72h (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72h (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 and 48 (mean)
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 8 days (no iris score documented on day 15)
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24,48 and 72h
Score:
0
Max. score:
2
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 and 48h
Score:
0
Max. score:
2
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal # 1 and # 2
Time point:
other: 24, 48 and 72h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 15 days (both)
Remarks on result:
other: both same mean score, both euthanised on d15 due to strong eye irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 and 48h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48 and 72h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: euthanised on d15 due to strong eye irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 and 48h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: rabbit deceased on day 3 (diagnosed coccidiosis)
Irritant / corrosive response data:
Both surviving rabbits were euthanased on day 15 due to severe irritation at the cornea (Draize score cornea: 3 or 4) and the conjunctiva (redness score: both 2; chemosis score: both 1).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information