Registration Dossier
Registration Dossier
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EC number: 700-890-7 | CAS number: 503614-91-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 September to 17 September, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- EPA 712-C-98-196
- GLP compliance:
- yes
- Remarks:
- OECD ENV/MC/CHEM(98017 and EC Directive 1999/11/EC
Test material
- Reference substance name:
- ethyl 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridine-3-carboxylate
- EC Number:
- 700-890-7
- Cas Number:
- 503614-91-3
- Molecular formula:
- C27 H28 N4 O5
- IUPAC Name:
- ethyl 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridine-3-carboxylate
- Details on test material:
- Powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: at least 8 weeks
- Weight at study initiation: 2.74kg to 3.00kg
- Housing: Individually in stainless steel cages with perforated floors.
- Diet: 125 gram of standard laboratory rabbit diet (STANRAB [P] SQC pellet) per day
- Water: ad libitum
- Acclimation period: at least 26 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 23°C
- Humidity (%): 40% to 70%
- Photoperiod (hrs dark / hrs light): 12 hrs of artificial light in each 24 hr period
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: additional site similarly treated with the exception of the test substance.
- Amount / concentration applied:
- 500 mg applied to a site pre-wetted with reverse osmosis water
- Duration of treatment / exposure:
- 4hr
- Observation period:
- on removal of the dressing and at 1hr, 24hr, 48hr and 72hr after the dressing was removed
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- No dermal reaction was observed in any animal throughout the duration of the study.
The test material does not labeling per GHS or EU CLP. - Executive summary:
There were no signs of toxicity or ill health in any rabbits during the observation period.
No dermal reaction was observed in any animal throughout the duration of the study
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