1,3-dichlorobenzene

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

1,3-dichlorobenzene

EC Number:

208-792-1

EC Name:

1,3-dichlorobenzene

Cas Number:

541-73-1

Molecular formula:

C6H4Cl2

IUPAC Name:

1,3-dichlorobenzene

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

pf 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

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.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

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

Results 5

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:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test item is not irritating to the eye according to CLP Regulation (EC) No 1272/2008.

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. The skin irritation/corrosion potential of the test substance was assesed in line with an OECD TG 405 study where under the conditions of this study, the test substance was determined to be irritating to the skin and a Category 2 skin irritant according to CLP Regulation (EC) No. 1272/2008. Therefore the substance was classified according to the CLP Regulation (EC) No. 1272/2008.