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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994 - 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
EC Number:
275-177-2
EC Name:
Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
Cas Number:
71077-34-4
Molecular formula:
C14H14N2O4S.Na
IUPAC Name:
sodium 4-[(3-amino-4-methylbenzoyl)amino]benzenesulfonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: Chbb: NZW (SPF)
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.4 - 3.2 kg
- Housing: in fully air-conditioned rooms, separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (ad libitum) and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Lighting time: 12 hours daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: isotonic saline at approx. 37°C.
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Cornea: 0 - 4; Iris: 0 - 2;
Conjunctiva: Redness: 0 - 3; Chemosis: 0 - 4; Discharge: 0 - 3

TOOL USED TO ASSESS SCORE: UV-light / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing of Amionotoluene sulfanilic acid Na salt for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
Executive summary:

The substance was tested for eye-irritation according to OECD guideline 405 with 3 femal rabbits.

About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluoresceinsodium solution. Only animals without ocular abnormalities were used for the study.

100 mg of the substance was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. 24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

One hour up to 24 hours after application the conjunctiva of the animals showed sporadically definitely injected blood vessels to more diffuse, deeper crimson red. A very slight swelling of the conjunctiva was observed one hour after application. Clear colorless discharge occurred one hour p.a. Two days after application all irritations were reversible.