Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 25 July 1995 to 31 July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
OECD guideline not specified.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test compound/batch: SR 48941 2/batch 5SNP501.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Three New Zealand White rabbits, two males and one female, identified by vendor attached plastic ear tag or implanted microship and study animal identification number written with indelible ink pen inside the right ear and housed one per cage.
- Source: Hazleton Research Products, Inc
- Age at study initiation: three to six months old
- Weight at study initiation: rabbits were weighed on Day-1 and body weights ranged from 3.0 to 3.5 kg.
- Housing: the rabbits were caged in an environmentally controlled room
- Diet: 125 grams/rabbit/day of Purina Certified High Fiber Rabbit Chow No. 5325 Lot 17 May 95 2A and 15 June 95 1B
- Water (e.g. ad libitum): municipal water (via an automatic watering system)

ENVIRONMENTAL CONDITIONS
- Temperature: 64-68°F
- Relative Humidity: 40-60 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycles.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: No control article was used; untreated sites served as controls
Amount / concentration applied:
100 mg of pulverized solid compound
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3, two males and one female
Details on study design:
On Day 4 of the study, 100 mg of pulverized solid compound was placed in the conjunctival sac of the right eye, the left eye serving as control. Sodium fluorescein was instilled into the eye, followed by irrigation with 10 mL saline, at pretreatment and beginning at the 24 hr grading to determine the presence or absence of stainable corneal opacification and to evaluate the affected areas. If an effect was observed at 24 hr, sodium fluorescein was intilled into eye at 48 and 72 hrs.

OBSERVED EFFECTS AND MORTALITY
The rabbits were observed at least once daily throughout the study, until termination on Day 7, for changes in appearance and behavior and mortality.

BODY WEIGHTS
The rabbits were weighed on Day -1.

OBSERVATION AND SCORING
Control and treated eyes were assessed for ocular lesions 1 hr (Day 4), then 24 (Day 5), 48 (Day 6) and 72 (Day 7) hrs after application of the test compound.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
Degree Opacity
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Surface Opacity
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
within the 72 hrs of observation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
Degree Opacity
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Surface Opacity
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
within the 72 hrs of observation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
1.3
Max. score:
3
Reversibility:
not reversible
Remarks:
within the 72 hrs of observation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Remarks:
Degree Opacity
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Surface Opacity
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
SR 48941 (batch 5SNP501) produced a slight reponse in all three animals. Mild conjunctival redness (vessels more injected than normal), conjunctival discharge (score 1 or 2), and chemosis (score 1 or 2) were observed in all three animals. The irritation responses were diminished or absent within 72 hours exposure. The cornea and iris were unaffected.
Other effects:
No clinical signs of toxicity were observed in any rabbit and no deaths occurred during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, SR 48941 (batch 5SNP501) is not a reportable eye irritant.