Registration Dossier

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: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Nitrobenzoylaminobenzamid TTR

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.2 - 3.6 kg
- Housing: fully air conditioned rooms, single cages (battery housing)
- Diet: Altromin 2123, rabbit diet, ad libitum plus 15 g hay per day
- Water: deionisized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark /12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye served as control
Amount / concentration applied:
100 mg of the test article were applied into the conjunctiva of the left eye
Duration of treatment / exposure:
24 hours
rinsing with physiol. saline at the end of the exposure period
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: physiologic NaCl-solution (temp. 37°C)
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae redness: 0 - 3; conjunctivae chemosis: 0-4

TOOL USED TO ASSESS SCORE: UV lamp / fluorescein-sodium-solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 7, 100, 164 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: # 7, 100, 164 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal: # 7, 164 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: # 100
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
3
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal: # 7
Time point:
other: mean of 24, 48, and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: # 100, 164 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritant / corrosive response data:
initial slight discharge was fully reversible within 24 h
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this study the test item is considered not to be irrtant to the eye.
Executive summary:

Eye irritant properties of N-(4-carbamoylphenyl)-4-nitrobenzamide were tested according to OECD 405 (100 mg/eye) in three New Zealand Whiter rabbits. 24 hours after instillation the treated eyes were washed. Mean scores (mean of 24, 48 and 72 h) were calculated for each rabbit.

Only slight effects were obsereved which were fully reversible within 48 h.

Based on the findings in this study the test item is considered not to be irrtant to the eye.