Registration Dossier
Registration Dossier
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EC number: 412-640-1 | CAS number: 84632-50-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-06-24 to 1993-04-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted Sep. 19, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 412-640-1
- EC Name:
- -
- Cas Number:
- 84632-50-8
- Molecular formula:
- C20 H10 N4 O2
- IUPAC Name:
- 3-[4-(3-cyanophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Appearance: orange powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: seven to ten weeks
- Weight at study initiation: 207 to 258 g
- Fasting period before study: no
- Housing: individually in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Biosure LAD 1) ad libitum
- Water: drinking water ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 22°C
- Humidity: 49% (daily mean)
- Air changes: approximately 10 to 15 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: From: 1993-01-19 To: 1993-02-02
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- distilled
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: approximately 10% of the total body surface
- Type of wrap if used: the gauze, which covered the application site, was held in place with a non-irritative dressing
REMOVAL OF TEST SUBSTANCE
- Washing: the treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper
- Time after start of exposure: at the end of the 24 hours exposure period
TEST MATERIAL
- Amount applied: 2.0 g / kg bodyweight
- Administration volume: 4.0 mL / kg bodyweight
- Concentration: 50 % w/v in distilled water - Duration of exposure:
- 24 hours
- Doses:
- 2.0 g / kg bodyweight
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Cage side observations: at least twice daily
- Clincal signs: soon after dosing and at frequent intervals for a period of 5 hours. On subsequent days once in the morning and at the end of the experimental day.
- Body weight: on Days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Dermal responses: erythema, eschar and oedema formation (daily scoring, 0 - 4) - Statistics:
- No
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single dermal application of test item at 2.0 g / kg bodyweight.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
- Other findings:
- DERMAL RESPONSES
Staining (orange) prevented assessment of erythema for all rats on Day 2; no evidence of oedema was recorded at this time. Although some residual (orange) staining was apparent on Days 3 and 4, there were no signs of erythema or oedema at any of the application sites from Day 3 to the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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