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EC number: 208-792-1 | CAS number: 541-73-1
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:
- 1 980
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
- 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%
Constituent 1
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:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not reversible
- 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
- 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
|
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.
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