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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

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)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lutropur Q
- Physical state: liquid, unchanged
- Analytical purity: technical
- Impurities: none
- Lot/batch No.: P. 282

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.0 kg; females 3.03 kg mean
- Housing: single
- Diet: 130 g/animal/day
- Water: 250 ml/day
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: negative control: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
not washed out
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
SCORING SYSTEM: OECD Draize (OECD 405)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72
Score:
0.3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.6
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Reversibility:
fully reversible within: 8 d
Other effects:
Symptoms:
Animal 1: pupil contracted from 1 to 72 h; small retractions of the eyelids from 24 h till the end of the observation period; loss of corneal tissue at 72 h
Animal 2: pupil contracted from 1h to 8 d; small retractions in the eyelids from 24 h till the end of the observation period; loss of corneal tissue from 24 h to 8 d; suppuration at 48 and 72 h
Animal 3: loss of corneal tissue from 24 h to 8 d; pupil contracted from 48 h to 8 d; small retractions of the eye lids from 48 h till the end of the observation period; suppuration at 48 and 72 h; loss of hair at margins of eyelids from 8 d till the end of the observation period

Any other information on results incl. tables

Table of individual scores:

 Readings   animal Cornea Iris Conjuctiva
Redness Chemosis
24 h 1 1 0 2 1
2 1 1 2 1
3 1 0 2 1
48 h 1 1 1 2 0
2 1 1 2 1
3 1 0 2 1
72 h 1 1 0 2 0
2 1 1 2 0
3 1 1 2 1
8 d 1 0 0 0 0
2 1 0 2 0
3 1 0 2 0
15 d 1 0 0 0 0
2 0 0 0 0
3 0 0 0 0

Applicant's summary and conclusion