3-amino-4-chlorobenzamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD405, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-4-chlorobenzamide

EC Number:

243-231-4

EC Name:

3-amino-4-chlorobenzamide

Cas Number:

19694-10-1

Molecular formula:

C7H7ClN2O

IUPAC Name:

3-amino-4-chlorobenzamide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst Kastengrund, Germany
- Strain: Albino New Zealand rabbit, normal breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: single cages arranged in a battery
- Diet: Altromin 2123 ad libitum + straw
- Water : de-ionized and chlorinated water ad libitum

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eyes served as control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h after beginning of treatment

Number of animals or in vitro replicates:

3

Details on study design:

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 % 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 right 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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect occured

Remarks on result:

other: no effect on any single animal

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: not relevant since no effect occured

Remarks on result:

other: no effect on any single animal

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24, 48, 72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible within: 48 h after treatment

Remarks on result:

other: highest mean score of two single animals: 0.3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect occured

Remarks on result:

other: no effect on any single animal

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification acc. to (EC) 1272/2008: not irritating

Executive summary:

Test material was subject to a test of eye irritancy according to OECD Guideline 405. 100 mg of substance were applied to one eye of three animals. Mean values of the 24, 48 and 72 h readings were calculated for each animal. Only slight effects (conjunctival redness mean score: <=0.2, corneal opacity, iridial effects, chemosis mean score of each: 0) below the threshold for classification were determined. All effects were fully reversible.Based on these findings the test material was judged no to be irritating to the eye.