Registration Dossier
Registration Dossier
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EC number: 609-425-1 | CAS number: 374067-80-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-28 to 2003-05-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study performed according 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, testing methodology and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : No information on the test substance was provided (including purity information); limited information on the preparation of the test substance and test site; limited information on the application of the test substance and the test animals
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : No information on the test substance was provided (including purity information); limited information on the preparation of the test substance and test site; limited information on the application of the test substance and the test animals
- GLP compliance:
- no
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring program, but no formal claim of GLP compliance is made for this study.
Test material
- Reference substance name:
- 4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile
- EC Number:
- 609-425-1
- Cas Number:
- 374067-80-8
- Molecular formula:
- C11H8N4O2
- IUPAC Name:
- 4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-4370561-AAA (T002326)
- Physical state: solid (powder)
- Appearance: slight beige 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: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: From: 2003-05-28 To: 2003-05-31
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Skin irritation/corrosion was scored according to the Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals number 69, 70 and 71
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals number 69, 70 and 71
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritant / corrosive response data:
- - No evidence of skin irritation was noticed at any time at any test site.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
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