Registration Dossier
Registration Dossier
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EC number: 700-303-4 | CAS number: 84163-13-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-21 to 2003-05-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Study performed according the the OECD guideline 404 and the EU test method B.4 with limited documentation on test conditions / 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:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- study performed in GLP compliant facility, but not QA audited
Test material
- Reference substance name:
- 6-FLUORO-3-(PIPERIDIN-4-YL)-1,2-BENZOXAZOLE HYDROCHLORIDE
- EC Number:
- 700-303-4
- Cas Number:
- 84163-13-3
- Molecular formula:
- C12H13FN2O.HCl
- IUPAC Name:
- 6-FLUORO-3-(PIPERIDIN-4-YL)-1,2-BENZOXAZOLE HYDROCHLORIDE
- Test material form:
- solid: particulate/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
- Source: one male and two female New Zealand White rabbits, no further data on test animals
ENVIRONMENTAL CONDITIONS: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- 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: no data
OBSERVATION TIME POINTS
- 1, 24, 48, 72 hours after administration
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- 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 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.
Based on the CLP regulation (EC) No 1272/2008, the test item does not need to be classified (all scores 0).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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