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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
435-030-7
EC Name:
-
Cas Number:
26452-81-3
Molecular formula:
C5H5N2OCl
IUPAC Name:
435-030-7
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3004 - 3154 g
- Housing: individually, in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): ≥15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg into the conjunctival sac of the left eye. The lids were then gently held together for 1 - 2 seconds.
Duration of treatment / exposure:
once
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
1 female, 2 males
Details on study design:
REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: The eyes were examined and the Draize scale was used to assess the grade of ocular reaction approx. 1 hour and 1, 2, 3, and 4 days after application.
TOOL USED TO ASSESS SCORE: fluorescein
OTHER: Immediately after the application of the test substance, an assessment of the initial pain reaction of the rabbit was made using a six-point scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal: #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No corneal opacity noted during the course of the study
Irritation parameter:
cornea opacity score
Basis:
animal: #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No corneal opacity noted during the course of the study
Irritation parameter:
cornea opacity score
Basis:
animal: #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No corneal opacity noted during the course of the study
Irritation parameter:
iris score
Basis:
animal: #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within:
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal: #2
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal: #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
There were no corneal effects. Slight iritis was seen in all animals for up to 3 days. Conjunctival effects were seen in all animals and consisted of slight or moderate redness for 3 days, slight or mild chemosis for up to 2 days and a slight or moderate discharge for up to 1 day. Additional signs of irritation comprised lachrymatory or mucoid discharge and dried secretion around the periorbital skin. One animal was holding its dosed eye closed approximately 1 hour after application, which may be indicative of pain. All signs of irritation had completely resolved 4 days after application.
Other effects:
There were no signs of ill-health in any animal during the study.
Application into the eye caused practically no or slight initial pain (class 1 - 2 on a 0 - 5 scale).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is considered to be slightly irritating to the rabbit eye.
Executive summary:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (100 mg) was applied into one eye of three New Zealand White rabbits. An assessment of initial pain was made and the eyes were examined for 4 days to assess the grade of ocular reaction. Application into the eye caused practically no or slight initial pain (class 1 - 2 on a 0 - 5 scale). There were no corneal effects. Slight iritis was seen in all animals for up to 3 days. Conjunctivae effects were seen in all animals and consisted of slight or moderate redness for 3 days, slight or mild chemosis for up to 2 days and a slight or moderate discharge for up to 1 day. Additional signs of irritation comprised lachrymatory or mucoid discharge and dried secretion around the periorbital skin. One animal was holding its dosed eye closed approximately 1 hour after application, which may be indicative of pain. All signs of irritation had completely resolved 4 days after application. Under the conditions of this experiment, the test substance was found to be slightly irritating. All observed effects were non-classifiable.