Registration Dossier
Registration Dossier
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EC number: 258-771-6 | CAS number: 53786-28-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-07-01 to 2003-07-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
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:
- no
- Qualifier:
- according 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, 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:
- 5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one
- EC Number:
- 258-771-6
- EC Name:
- 5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one
- Cas Number:
- 53786-28-0
- Molecular formula:
- C12H14ClN3O
- IUPAC Name:
- 5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): T000990
- Physical state: solid (powder)
- Appearance: slight beige powder
Constituent 1
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): not applicable
- Duration of treatment / exposure:
- Single 4-hour treatment
- Observation period:
- 1, 24, 48, and 72 hours after administration
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE: no data
REMOVAL OF TEST SUBSTANCE: no data
SCORING SYSTEM:
according to Draize J H (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 8
- Reversibility:
- fully reversible within: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Male number 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Male number 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Male number 18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Male number 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Male number 17
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Male number 18
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No evidence of skin irritation was reported. All animals received a score of 0 for erythema and edema at 1, 24, 48 and 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was reported not to be a skin irritant under the test conditions.
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