Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Analytical purity not reported. Draize score. Observational period was too short. Eyes were not rinsed after exposure
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): m-dichlorobenzene
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop, Meerbusch, Germany
- Weight at study initiation: 3.1 Kg
- Housing: the animals were individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40%

- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


Test system

Vehicle:
not specified
Controls:
other: the left eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL
Duration of treatment / exposure:
8 days
Observation period (in vivo):
24, 48, 72 hours and 8 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize score


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
pf 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.55
Max. score:
3
Reversibility:
other: During the observation period of 8 days, 1/6 animal presented, diffuse, carmine redness. Individual vessels were not easily distinguishable.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.4
Max. score:
4
Reversibility:
other: During the observation period of 8 days, 1/6 animal presented slight swelling (any swelling) above normal, and 1/6 one animal presented distinct swelling with partial detachment of the eyelid
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.35
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
see Remarks on results including tables and figures

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Redness

Conjunctiva

Chemosis

Discharge

24h

1

0

0

0

0

0

24h

2

1

0

1

0

0

24h

3

0

0

0

0

0

24h

4

0

0

0

0

0

24h

5

0

0

1

1

0

24h

6

1

0

1

1

1

48h

1

0

0

0

0

0

48h

2

1

0

1

0

0

48h

3

0

0

0

0

0

48h

4

0

0

0

0

0

48h

5

0

0

2

1

0

48h

6

1

0

1

1

0

72h

1

0

0

0

0

0

72h

2

0

0

2

1

0

72h

3

0

0

0

0

0

72h

4

0

0

0

0

0

72h

5

0

0

0

0

0

72h

6

1

0

2

2

3

Mean24-72h

 

1

0

0

0

0

0

Mean24-72h

 

2

0.7

0

1.3

0.3

0

Mean 24-72h

 

3

0

0

0

0

0

Mean 24-72h

 

4

0

0

0

0

0

Mean 24-72h

 

5

0

0

1

0.7

0

Mean 24-72h

 

6

1

0

1.3

1.3

1.3

Total Mean

 

0.3

0

0.55

0.4

0.35

 

e (hrs)

Individual scoring

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

Corneal opacity

8 days

0

0

0

0

0

0

Iritis

8 days

0

0

0

0

0

0

Redness

8 days

0

2

0

0

0

0

Chemosis

8 days

0

1

0

0

0

2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

The eye irritation/corrotion effects of 1,3-dichlorobenzene were tested with a test similar to OECD guideline 405 with acceptable restrictions (Analytical purity not reported. Draize score. Observational period was too short. Eyes were not rinsed after exposure).

 

The test substance was applied into the conjunctival sac (right lower eyelids) of 6 rabbits. The evaluation was made using an ophthalmoscope.
The corneal findings were 8 days after the treatment confirmed with the fluorescein test

According to the findings of this test 1,3-dichlorobenzene can be considered as not irritating to eyes.