1,3-dichlorobenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented report which meets basic scientific principles

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 404 (Acute Dermal Irritation / Corrosion)

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
- Physical state: liquid
- Analytical purity: 99%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: W. Ostrop, Meerbusch, Germany

- Weight at study initiation: 3.1 kg
- Housing: animals were housed in a single cage
- 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): 12hrs dark/ 12hrs light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: alcool

Controls:

other: not applicable

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500µL

Duration of treatment / exposure:

24 hours

Observation period:

8 days

Number of animals:

6

Details on study design:

The skin of the flank of 6 rabbits was depilated with an electric hair cutting machine 24 hours before the start of the test on both sides of the body in an area of approximately 8x8 cm. The skin of the right flank on the treatment area was additionally scarified with a scarificator.
A 2.5 x 2.5 cm Patch made of double layers surgery gauze was filled / soaked with 500µL of the liquid test substance and covered with an indifferent, impermeable PVC-foil.

The PVC-foil together with the underlying Patch was fixed with adhesive strip (Leukoflex®) at two treatment sites. Subsequently, the entire body of the animals was wrapped for the duration of the exposure time of 24 h with elastic with a binder (Eloflex®). The animals were immobilized.



SCORING SYSTEM: Draize score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

other: erythema score abraded skin

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48, 72 hours

Score:

0.8

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

other: edema score abraded skin

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48, 72 hours

Score:

3

Max. score:

4

Reversibility:

not reversible

Any other information on results incl. tables

Readingsintactskin  Animal  Erythema  Edema  24 h  1  0  4  24 h  2  0  3  24 h  3  0  3  24 h  4  0  3  24 h  5  0  3  24 h  6  0  3  48 h  1  0  4  48 h  2  0  3  48 h  3  0  3  48 h  4  0  3  48 h  5  0  3  48 h  6  0  3  72 h  1  2  3  72 h  2  2  2  72 h  3  2  1  72 h  4  3  1  72 h  5  3  2  72 h  6  3  1  Mean24 -72h  1 0.7  3.7   Mean 24 -72h  2 0.7 2.7   Mean 24 -72h  3 0.7 2.3  Mean 24 -72h  4 1 2.3  Mean 24 -72h  5 1 2.7  Mean 24 -72h  6 1 2.3 Total mean   0.85  2.7

 

 

Readingsabradedskin	Animal	Erythema	Edema
24 h	1	0	4
24 h	2	0	4
24 h	3	0	3
24 h	4	0	3
24 h	5	2	3
24 h	6	0	3
48 h	1	0	4
48 h	2	0	3
48 h	3	0	3
48 h	4	0	3
48 h	5	2	3
48 h	6	0	3
72 h	1	2	4
72 h	2	2	3
72 h	3	2	3
72 h	4	2	1
72 h	5	3	2
72 h	6	3	1
Mean24 -72h	1	0.7	4
Mean 24 -72h	2	0.7	3.7
Mean 24 -72h	3	0.7	3
Mean 24 -72h	4	0.7	2.3
Mean 24 -72h	5	1	2.7
Mean 24 -72h	6	1	2.3
Total mean		0.8	3

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of this study, the test item is irritating to the skin and a Category 2 skin irritant according to CLP Regulation (EC) No. 1272/2008.

Executive summary:

The primary irritant/corrosive effect of pure 1,3-dichlorobenzene, has been tested on rabbit skin with a Patch Test.

5 New Zealand White rabbits have been tested with 500µL of 1,3-dichlorobenzene for 24 hours followed by expsoure period of 8 days.

The evaluation of the skin demages was performed according to Draize.

Mean scores over 24, 48, and 72 hours for each animal were 2.7 for edema and 0.8 for erythema for intact skin, and 3 for edema and 0.8 for edema for abraded skin.

According to the CLP Regulation (EC) No. 1272/2008 the test substance was classified as a Category 2 skin irritant.