1-benzyl-4-piperidone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-06-04 to 2003-06-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Non-GLP study according to OECD guideline 404 and EU Method B4; however, the test substance is not adequately characterized and insufficient information is provided on the test animals, testing methodology and results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Insufficient information on the test substance, test animals

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Insufficient information on the test substance, test animals

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

Test material information

Constituent 1

Reference substance name:

1-benzyl-4-piperidone

EC Number:

222-782-4

EC Name:

1-benzyl-4-piperidone

Cas Number:

3612-20-2

Molecular formula:

C12H15NO

IUPAC Name:

1-benzylpiperidin-4-one

Test material form:

liquid

Details on test material:

- Identification: JNJ-728195-AAA
- Physical state: liquid
- Appearance: clear yellowish liquid

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: 3 New Zealand White rabbit
- 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:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): No data

Duration of treatment / exposure:

- single, 4-hour application: 4 hours
- 3-minutes and 1-hour application: 3 minutes and 1 hour

Observation period:

- single, 4-hour application: 1, 24, 48, 72 hours, 7 days and 14 days after administration
- 3-minutes and 1-hour application: 1, 24, 48 and 72 hours after administration

Number of animals:

- single, 4-hour application: 3 animals
- 3-minutes and 1-hour application: 1animal

Details on study design:

TEST SITE
- intact skin of rabbits, no further data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data


SCORING SYSTEM:
- erythema/eschar and oedema were scored according to the Draize scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 47

Time point:

24/48/72 h

Score:

0.667

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other:

Remarks:

4 hour exposure

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 118

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Remarks on result:

other:

Remarks:

4 hour exposure

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 119

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Remarks on result:

other:

Remarks:

4 hour exposure

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 47

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 4 hour exposure

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 118

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7d

Remarks on result:

other:

Remarks:

4 hour exposure

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 119

Time point:

24/48/72 h

Score:

0.333

Max. score:

4

Reversibility:

fully reversible within: 7d

Remarks on result:

other: 4 hour exposure

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 47

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other:

Remarks:

1 and 3 minute exposures

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 47

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other:

Remarks:

1 and 3 minute exposures

Irritant / corrosive response data:

After 4 hours of exposure only a very slight erythema, very slight oedema, a loss of skin elasticity and crust formation were reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered to be a mild irritant with a primary irritation index of 1.3. However, based on criteria of CLP regulation, the test item is not classified as the mean scores for erythema/edema are below the cut-off value of 1.5