3-amino-4-chlorobenzoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline Study, but non GLP and no purity of test item available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-4-chlorobenzoic acid

EC Number:

220-635-9

EC Name:

3-amino-4-chlorobenzoic acid

Cas Number:

2840-28-0

Molecular formula:

C7H6ClNO2

IUPAC Name:

3-amino-4-chlorobenzoic acid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: from own premises
- Weight at study initiation: 2-3kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
- Concentration (if solution): unchanged

Duration of treatment / exposure:

Eyes from 3 animals left unwashed. Eyes from 3 animals were washed out after 30 sec.

Observation period (in vivo):

day 1, 2, 3, 4, and 7

Number of animals or in vitro replicates:

3 female and 3 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with physiological saline for 3 animals
- Time after start of exposure: 30 sec

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: eyes not rinsed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: eyes not rinsed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: eyes not rinsed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: eyes not rinsed

Any other information on results incl. tables

Corneal opacity and iritis were not found at all. The single scores for conjunctival redness and chemosis are described in the table below:

	24 hours						48 hours						72 hours						4 days						7 days
Eye treatment	not rinsed			rinsed			not rinsed			rinsed			not rinsed			rinsed			not rinsed			rinsed			not rinsed			rinsed
Animal #	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
redness	1	2	2	1	1	1	0	0	2	1	1	1	0	1	1	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0
chemosis	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information