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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, 72 hours
Score:
0.8
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not reversible
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
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:
irritating
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 EU regulation 1,3-dichlorobenzene can be classified as Xi, 38 (irritating to skin) and according to EU-GHS regulations can be classified as Skin Irritation cat 2, H315 (causes skin irritation).