Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-8-11 to 1997-8-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 92480/J/17
- Expiration date of the lot/batch: Not supplied

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna UK Ltd and Charles River UK
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.9-3.1 kg
- Housing: Individualls in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Stanrab (P) SQC Rabbit Diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Of unknown period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 50-76
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
1 second
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:

Ocular irritation was assessed using the prescribed numerical system:

Cornea

Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre),
details offris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

Iris

Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or
injection, any of these or combination of any thereof, iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Conjunctivae

Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis (lids andlor nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-dosed 4

Any other lesion not covered by this scoring system was described.

TOOL USED TO ASSESS SCORE: handheld lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 60 min
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 60 min
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 60 min
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 60 min
Score:
ca. 1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 60 min
Score:
ca. 2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 60 min
Score:
ca. 2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
ca. 2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
ca. 1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
ca. 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 60 min
Score:
ca. 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 60 min
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 60 min
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. A diffuse crimson colouration of the conjunctivae was seen in two animals. Transient hyperaemia of conjunctival blood vessels with slight swelling was seen in one animal. Reactions had resolved completely by one, two or three days after instillation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
UK-92,480 does not meet GHS criteria in regards to eye irritation.