Registration Dossier
Registration Dossier
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EC number: 607-384-4 | CAS number: 244768-32-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-11-04 to 2004-11-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study is similar to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); however, the test substance is not adequately characterized and insufficient information is provided on the test animals.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Insufficient information on the test substance and test animals.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Insufficient information on the test substance and test animals.
- GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
Test material
- Reference substance name:
- 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE
- EC Number:
- 607-384-4
- Cas Number:
- 244768-32-9
- Molecular formula:
- C11H7ClN4
- IUPAC Name:
- 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-4754724-AAA (T002488)
- Physical state: solid
- Appearance: light brown powder
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- 3 male New Zealand White rabbits, no further data
ENVIRONMENTAL CONDITIONS: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact
- Vehicle:
- not specified
- Controls:
- other: Untreated skin areas of the test animals served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data - Duration of treatment / exposure:
- Method 1: 4 hours
Method 2: 3 minutes and 1 hour - Observation period:
- Method 1: 72 hours
Method 2: 72 hours - Number of animals:
- Method 1: 3
Method 2: 1 - Details on study design:
- TEST SITE: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
SCORING SYSTEM:
- according to Draize
- Primary Irritation Index
0 = Non-irritant
>0 - 2 = Mild irritant
>2 - 5 = Moderate irritant
>5 - 8 = Severe irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- following 4-hour exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: A score of 0 was obtained for the three rabbits.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- following 4-hour exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: A score of 0 was obtained for the three rabbits.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- following 3-minute exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not aplicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- following 3-minute exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- following 1-hour exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No evidence of skin irritation was noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be a non-irritant with a primary irritation index of 0.0.
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