2,3-dichlorobenzoic acid

Eye irritation

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,3-dichlorobenzoic acid

EC Number:

200-039-5

EC Name:

2,3-dichlorobenzoic acid

Cas Number:

50-45-3

Molecular formula:

C7H4Cl2O2

IUPAC Name:

2,3-dichlorobenzoic acid

Test material form:

solid: crystalline

Details on test material:

Test item: 2,3-DICHLOROBENZOIC ACID (CAS No.: 50-45-3)
Batch No.: L2A134N
Physical state: Solid, crystalline powder
Colour: White
Active ingredient content (titrimetry): 100.4%
Water content: 0.03 % (m/m)
Storage: 15-30°C, protected from moisture

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: S & K-LAP Kft.
Hygienic level during the study: good conventional
Number of animal: 3 males
Age of animals: adult rabbits, 16-17 weeks old
Body weight range at the beginning of the study: 2800 - 4050 g
Body weight range at the end of the study: 3062 - 4358 g
Acclimatisation time: 41 days in first animal, 42 days in second animal and 43 days in third animal
Animal health: Only animals in acceptable health condition were used for the test.

Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system
The environmental parameters were recorded daily during the study. Before housing the animals the microbiological status of the room was checked.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye served as control.

Amount / concentration applied:

0.1 g of the test item was used for the study in undiluted state, as a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours then 1 and 2 weeks after the application.

Number of animals or in vitro replicates:

3 male

Details on study design:

In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.
In the initial test slight and moderate to severe irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. Moderate to severe irritant effects were observed 24 hour after treatment. Following treatment of the second animal, the second confirmatory test was conducted using a third animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1.66 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 2 weeks

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

other: redness (conjunctival)

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1.66 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 2 weeks

Results 4

Irritation parameter:

chemosis score

Remarks:

(conjunctival)

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1.33 - <= 3

Max. score:

3

Reversibility:

fully reversible within: 2 weeks

Results 5

Irritation parameter:

other: conjunctival discharge

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1.33 - <= 3

Max. score:

3

Reversibility:

fully reversible within: 2 weeks

Irritant / corrosive response data:

Treated and control eyes were examined at 1, 24, 48 and 72 hours then 1 and 2 weeks after the application.
1 hour after the single application of test item into the eye of the rabbits, slight redness and chemosis of the conjunctivae, as well as moderate discharge of the conjunctivae occurred.
24 hour after the treatment the signs of eye irritation became stronger. Moderate redness, moderate to severe chemosis of the conjunctivae, moderate to severe discharge of the conjunctivae and moderate cornea opacity were detected. The area of cornea involved was greater than half, but less than three quarters in one animal and the area of cornea involved was greater than one quarter, but less than half in two animals.
1 week after the treatment one animal became free of symptoms. Slight redness of the conjunctivae and cornea opacity were observed. The area of cornea involved was greater than three quarters, up to the whole area.
2 weeks after treatment all animals were free of symptoms, so the study was finished.

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In conclusion, test item 2,3-dichlorobenzoic acid (CAS No. 50-45-3) applied to the rabbits' eye mucosa, caused slight to severe conjunctival and moderate corneal irritant effects, fully reversible within 2 weeks. The test item has been classified into Category 2A.