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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-nitro-p-toluic acid
EC Number:
202-549-3
EC Name:
3-nitro-p-toluic acid
Cas Number:
96-98-0
Molecular formula:
C8H7NO4
IUPAC Name:
4-methyl-3-nitrobenzoic acid
Details on test material:
purity: 99.5 %

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 - 3.7 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum; 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
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreted right eye was used as control
Amount / concentration applied:
100 mg test substance applied once to the conjunctival sac of the left eye
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: with isotonic saline at approx. 37°C.
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctivae: 0 - 3
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:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1day
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Time point:
other: 2 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 3 days
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 2 days
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eye but not sufficiently for classification.
Executive summary:

The substance was tested for eye irritation according to OECD guideline 405.

About 24 hours before the start of the study the test eyes of 3 New Zealand albino rabbits were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study. 100 mg of the test 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 .

One hour up to 2 days after application the conjunctivae of the animals showed an evident hyperaemie of the blood vessels to a diffuse, deeper crimson reddening and a slight swelling to a swelling with lids about half closed. The iris was reddened in one animal one day after application. Additionally a clear colourless discharge was noted. 3 days after application the irritations were reversible.