Registration Dossier
Registration Dossier
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EC number: 270-737-2 | CAS number: 68477-54-3 A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant study, GLP status unknown, limitations in reporting but otherwise acceptable.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Benzene
- EC Number:
- 200-753-7
- EC Name:
- Benzene
- Cas Number:
- 71-43-2
- Molecular formula:
- C6H6
- IUPAC Name:
- benzene
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Type of coverage:
- other: under exposure chamber
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Neat, 0.5 mL, to an area of 6cm2
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 144 h (i.e. 6 days) after end of application
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- > 2
- Reversibility:
- no data
- Remarks on result:
- other: erythema score 3.00 at 144 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: oedema only seen at 1 h
Any other information on results incl. tables
Mean scores (Draize et al 1944):
Time after end of application |
1 h |
24 h |
48 h |
72 h |
144 h |
Mean score for erythema |
1.00 |
2.00 |
2.20 |
2.40 |
3.00 |
Mean score for edema |
2.20 |
0.00 |
0.00 |
0.00 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Benzene is considered to be irritating to rabbit skin (mean over 24/48/72 h for erythema >2)
- Executive summary:
The irritation potential of benzene was assessed on the skins of six shaved rabbits exposed to neat benzene for 4 hours, using an exposure chamber of 6 cm2. One hour after exposure oedema grade 2 and erythema grade 1 were documented. No oedema, but mean scores of 2.0/2.2/2.4 for erythema were recorded at 24, 48, and 72 hours after the end of exposure. Erythema increased to a mean of grade 3 at 6 days.
It is concluded that benzene is irritating to rabbit skin and should be classified as Xi, R38. Under CLP it is proposed that the appropriate classification is Category 2, H315.
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