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:
1987-12-08 to 1988-03-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. No GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main; Germany
- Weight at study initiation: Males: 3.13 kg; Female: 2.88 kg;
- Housing: single animals in stainless steel cages with wire mesh walk floors; floor area: 40 x 51 cm
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; abt. 130 g per animal per day
- Water: abt. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%):30 -70
- Photoperiod (hrs dark / hrs light): !2 h/12 h (6 .00 - 18 .00 hours/18 .00 - 6 .00 hours)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye served as negative control.
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 ( 2 males, 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983;

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24,48,72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(0212)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(0296)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(0194)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
Not irritating
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information