Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-Mar-2003 - 06-Aug-2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: white powder
- Analytical purity: 99.2%
- Lot/batch No.: 4673
- Storage condition of test material: at room temperature, protected from humidity and under nitrogen gas.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Breeder: CEGAV, Saint Mars d'Egrenne, France.
- Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.8 ± 0.2 kg
- Food and Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
Duration of treatment / exposure:
continuous
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0.7
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0.3
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0.3
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
2.3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
Alopecia around the eye in animal #3.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under our experimental conditions, the test item NaTG 98%, pure is slightly irritant when administered by ocular route to rabbits.
Executive summary:

The objective of this study was to evaluate the potential of the test item NaTG 98%, pure to induce irritation following a single ocular administration in rabbits.

No iritis and no corneal opacity were recorded. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.3 and 2.3 for chemosis, 0.7, 0.3 and 2.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.