Registration Dossier
Registration Dossier
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EC number: 282-544-0 | CAS number: 84254-97-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-01-18 to 2006-01-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Limited documentation available in study report summary but study conducted according to OECD guideline 404 and EU Method B.4, with no discussion deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.
Test material
- Reference substance name:
- 1'-(phenylmethyl)-[1,4'-bipiperidine]-4'-carbonitrile
- EC Number:
- 282-544-0
- EC Name:
- 1'-(phenylmethyl)-[1,4'-bipiperidine]-4'-carbonitrile
- Cas Number:
- 84254-97-7
- Molecular formula:
- C18H25N3
- IUPAC Name:
- 1'-benzyl-[1,4'-bipiperidine]-4'-carbonitrile
- 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: three New Zealand White rabbits, nu further details on test animals
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: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after administration
SCORING SYSTEM:
- according to Draize
Primary Irritation Index Classification
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
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritation was noted based on Draize classification.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No evidence of skin irritation was noted.
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