2,3-dichlorobenzaldehyde

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:

2015

Report date:

2015

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-dichlorobenzaldehyde

EC Number:

228-711-3

EC Name:

2,3-dichlorobenzaldehyde

Cas Number:

6334-18-5

Molecular formula:

C7H4Cl2O

IUPAC Name:

2,3-dichlorobenzaldehyde

Test material form:

solid: crystalline

Details on test material:

Test item: 2,3-dichlorobenzaldehydeCas No.: 6334-18-5Storage: 15-30 °C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species and strain: New Zealand white rabbitSource: S&K LAP Kft.Hygienic level during the study: good conventionalNumber of animal: 3 malesAge of animals: adult rabbits, 13 weeks oldBody weight range at the beginning of the study: 2200 - 2520 gBody weight range at the end of the study: 2250 - 2580 gAcclimatisation time: 10 days in first animal and 11 days in second and third animalHusbandryAnimal 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 °CRelative humidity: 30-70 %Ventilation: 10-15 air exchanges/hour by central air-condition system

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g of the finely grounded test item was used for the study, 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 1week after the application.

Number of animals or in vitro replicates:

Three male animals in acceptable health condition were selected for the test.

Details on study design:

Procedure:The test item was applied in a single dose to the left eye of animals. The degree of irritation was observed and scored at specified intervals. Information derived from this test served to indicate the existence of possible hazards likely to arise from exposure of the eyes and associated mucous membranes to the test item. At termination animals were sacrificed.A Single Animal Test: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 no irritant effect was observed 24 hours after the treatment. The confirmatory test was conducted using a second and third animal.Application of the Test Item:The test item was instilled into the conjunctival sac of the left eye of each animal. The eye lids were gently held closed for about one second to prevent the loss of the test item. The contralateral eye serves as control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Results 4

Irritation parameter:

iris score

Basis:

animal: 1; 2; 3

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 2; 3

Time point:

24/48/72 h

Score:

1

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Results 9

Irritation parameter:

other: conjunctival discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

other: conjunctival discharge

Basis:

animal: 2; 3

Time point:

24/48/72 h

Score:

0.66

Other effects:

No systemic toxicity was observed on the day of the treatment and during the 1-week observation period. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was observed in all animals. This symptom was detected between the treatment day and first observation of Day 1.

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

In conclusion, test item 2,3-DICHLORO-BENZALDEHYDE (CAS 6334-18-5) applied to the rabbits' eye mucosa caused slight to severe conjunctival and slight to moderate cornea irritant effects which were fully reversible within 1 week.The test item can be classified into hazard Category 2B for eye irritation.