Registration Dossier
Registration Dossier
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EC number: 263-731-6 | CAS number: 62780-89-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-10-01 to 2004-09-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to 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). The study was non-GLP and limited information was given on the test substance, test animals and methodology.
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:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. No formal claim of GLP compliance is made for this study.
Test material
- Reference substance name:
- 1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one
- EC Number:
- 263-731-6
- EC Name:
- 1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one
- Cas Number:
- 62780-89-6
- Molecular formula:
- C10H11ClN2O
- IUPAC Name:
- 1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-119717-AAA (T001036)
- Physical state: solid
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: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data
VEHICLE: no data - Duration of treatment / exposure:
- single 4-hour application
- Observation period:
- Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
- Number of animals:
- three male rabbits
- 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
SCORING SYSTEM:
Scored according to the Draize scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: based on 24 and 72 hour readings
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Non-Irritant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 158
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 168
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 175
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 158
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 168
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 175
- 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.
- Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No evidence of skin irritation was noted. The test item did not meet the criteria for classification as irritant or corrosive according to the criteria of the CLP Regulation (EC) No 1272/2008.
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