Registration Dossier
Registration Dossier
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EC number: 259-224-4 | CAS number: 54553-90-1
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)
Data source
Reference
- Title:
- No information
- Author:
- Anonymous
- Year:
- 2 007
- Bibliographic source:
- IUCLID4 data set, 2007
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
- EC Number:
- 259-224-4
- EC Name:
- Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
- Cas Number:
- 54553-90-1
- Molecular formula:
- C10H6O8.C9H10N2
- IUPAC Name:
- benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- male/female (each 3)
Test system
- Type of coverage:
- occlusive
- Vehicle:
- other: paraffin oil
- Controls:
- other: animals were their own control
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h exposure
- Observation period:
- 8 days
- Number of animals:
- 6 (3 male and 3 female)
- Details on study design:
- TEST ANIMALS:
- Strain: New Zealand white
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 3.7 - 4.9 kg
- Number of animals: 3 males, 3 females
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: 8 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, 6 and 8 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:
- other: 4h
- Score:
- 1.28
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.11
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8d
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 1.29
- Max. score:
- 8
- Reversibility:
- fully reversible within: 8d
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.28
- Edema: 0.11
- irritation index: 1.29/8
REVERSIBILITY: complete within 8 days
OTHER EFFECTS: eschar formation in 3 animals (day 6)
Any other information on results incl. tables
See also attached IUCLID4 dossier.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification : not irritating
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