Registration Dossier
Registration Dossier
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EC number: 259-224-4 | CAS number: 54553-90-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Limit test:
- 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:
- rat
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- a total of 10 animals
- Details on study design:
- TEST ORGANISMS:
- Strain: Hsd/Win:WU / SPF
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Weight at study initiation: 200-300 g
- Controls: no
ADMINISTRATION:
- Area covered: dorsolumbar region, 50 x 50 mm2 = approximately 10 % of
the body surface
- Concentration in vehicle: 40 g/100 ml (suspension)
- Total volume applied: 5 ml/kg bw
- Occlusion: semiocclusive gauze dressing
- Removal of test substance: after 24 hours with warm water and absorbent
paper
EXAMINATIONS:
- Mortality: twice daily
- Clinical signs: 30 minutes after dosing, hourly thereafter for about 6 hours,
once daily for next 14 days
- Dermal response: once a day for 14 days
- Body weights: days 0 (prior to dosing), 7, and 14
- Macroscopic examination: day 14
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- MORTALITY: There were no deaths.
- Clinical signs:
- other: CLINICAL SIGNS: There were no signs of systemic reaction to treatment. After removal of the dressing until the end of the study no skin irritations were noticed. Body weight gain was satisfactory in males but low in females, which is a physiological findi
Applicant's summary and conclusion
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