Registration Dossier
Registration Dossier
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EC number: 928-634-1 | CAS number: 618061-76-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 30 - May 5, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EC guideline B.4 and OECD guideline 404
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- diethyl [({4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-oxolan-3-yloxy]quinazolin-6-yl}carbamoyl)methyl]phosphonate
- EC Number:
- 928-634-1
- Cas Number:
- 618061-76-0
- Molecular formula:
- C24 H27 Cl F N4 O6 P
- IUPAC Name:
- diethyl [({4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-oxolan-3-yloxy]quinazolin-6-yl}carbamoyl)methyl]phosphonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- sex: 3 males
age: approx 5.5-6.5 months
initial body weight: 2.3-2.6 kg
Diet: ssniff K-H V2333 served as food
Drinking water was offered ad libitum
Housing:
room temp = 20 +/- 3degC
relative humidity = 55% +/- 15%
rooms were lit (150 lux at approx. 1.5 m room height) and darkened on a 12-hr light/12-hour dark cycle
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg/patch and animal (4000 mg of the ground test substance was mixed with 4 mL aqua ad iniectabilia, 1000 mg of this paste was applied per animal (a 500 mg test substance/animal))
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
- Details on study design:
- The reactions of the intact skin were evaluated at 60 minutes and then at 24, 48 and
72 hours after patch removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to CLP
- Conclusions:
- Under the present test conditions none of three rabbits exposed for 4 hours to 500 mg
BIBW2992MA2/CDBB0250BS/patch and animal (semi-occlusive condition) showed any
substance-related lesions.
There were no systemic intolerance reactions.
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