Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
2006
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

Constituent 1
Chemical structure
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
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.