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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Insufficient information on the test substance, test animals
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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
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
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