Registration Dossier
Registration Dossier
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EC number: 259-226-5 | CAS number: 54553-91-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- GLP was not implemented at the date of study conduct.
Test material
- Reference substance name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
- EC Number:
- 259-226-5
- EC Name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
- Cas Number:
- 54553-91-2
- Molecular formula:
- C10H6O8.2C9H10N2
- IUPAC Name:
- benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.6 - 5.0 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: paraffin oil
- Controls:
- other: animals were their own control
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h exposure
- Observation period:
- 10 days
- Number of animals:
- 6 (3 male and 3 female)
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: 0.5 g wetted with paraffin oil
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 10 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 7, and 10 days after patch removal; evaluation based on readings 1-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.28
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10d
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.17
- irritation index: 1.25/8
Examination time points: 1, 24, 48, 72 hours, 7, and 10 days after patch removal
evaluation based on readings 1-4
REVERSIBILITY: complete within 10 days
OTHER EFFECTS: eschar formation in the males (day 7)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification : not irritating
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