Registration Dossier
Registration Dossier
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EC number: 203-623-8 | CAS number: 108-86-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct - Nov 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Please refer to analogue justification provided in IUCLID section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 28 Jul 2015
- Deviations:
- yes
- Remarks:
- no initial test was performed
- GLP compliance:
- no
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
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: about 3000 g
- Housing: individual housing under standardized coditions
- Diet: Ssniff K (Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 1, 24, 48 and 72 h and 6 days - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 x 6 cm on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with an elastic and air permeable bandage
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 6 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system
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:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- All animals showed moderate erythema and slight edema on the application sites that were fully reversible within 6 days.
Any other information on results incl. tables
Table 1: Results of skin irritation
| Observation time | Rabbit no. | |||||
| 1 | 2 | 3 | ||||
| Erythema | Edema | Erythema | Edema | Erythema | Edema | |
| 1 h | 3 | 0 | 3 | 0 | 2 | 0 |
| 24 h | 3 | 1 | 3 | 1 | 2 | 1 |
| 48 h | 3 | 1 | 3 | 1 | 2 | 1 |
| 72 h | 3 | 1 | 3 | 1 | 2 | 1 |
| Mean value 24 + 48 + 72 h | 3,00 | 1,00 | 3,00 | 1,00 | 2,00 | 1,00 |
| 6 d | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- CLP: Skin Irrit 2, H315
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