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EC number: 203-628-5 | CAS number: 108-90-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Chlorobenzene
- EC Number:
- 203-628-5
- EC Name:
- Chlorobenzene
- Cas Number:
- 108-90-7
- Molecular formula:
- C6H5Cl
- IUPAC Name:
- chlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): chlorobenzene pure
- Physical state: liquid
- Analytical purity: pure (further data not reported)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: approx. 3.0 Kg
- Diet (e.g. ad libitum): Standard diet ("Ssniff K" provided from Versuchstierdiäten GmbH, Soest/Westfalen) availabe ad libitum
- Water (e.g. ad libitum): tap water available ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 h light cycle
IN-LIFE DATES: From: October To: November 1982
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin areas of the test animal serve as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze patch of approximaltely 2.5 * 2.5 cm²=6.25 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water was used to wash the area treated
- Time after start of exposure: 4 hours from the end of the treatment
SCORING SYSTEM: according to Draize method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- All 3 animals showed marked erythema and edema on the application sites. The intensity of the skin reaction pertained the margins of the application sites. Until 3 days after the treatment skin desquamation was observed. No significant differences in skin reaction appeared among each animal.
Any other information on results incl. tables
| Readings | Animal | Erythema | Edema |
| 24 h | 64 | 3 | 1 |
| 24 h | 95 | 3 | 1 |
| 24 h | 100 | 2 | 1 |
| 48 h | 64 | 3 | 1 |
| 48 h | 95 | 3 | 1 |
| 48 h | 100 | 2 | 1 |
| 72 h | 64 | 3 | 1 |
| 72 h | 95 | 3 | 1 |
| 72h | 100 | 2 | 1 |
| Mean 24 -72h | 64 | 3 | 1 |
| Mean 24 -72h | 95 | 3 | 1 |
| Mean 24 -72h | 100 | 2 | 1 |
| Total mean | 2.7 | 1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Executive summary:
Suber H, 1983.
The primary irritant/corrosive effect of pure chlorobenzene, has been tested on rabbit skin according to "OECD Guideline for Testing of Chemicals No. 404" without deviations. 3 New Zealand White rabbits have been tested with 0.5 mL of pure chlorobenzene for 4 hour-exposure followed by a post expsoure period of 14 days. The evaluation was performed according to Draize.
All 3 animals showed marked erythema and edema on the application sites. The intensity of the skin reaction pertained the margins of the application sites. Until 3 days after the treatment skin desquamation was observed. No significant differences in skin reaction appeared among each animals.
Mean scores over 24, 48, and 72 hours for each animal were 2.7 of max 4 for erythema and 1 of max4 for edema.
According to EU-GHS regulations chlorobenzene shall be classified as "Skin irritation cat 2, H315". The definition of this category is: causes skin irritation.
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