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:
2004-02-25 to 2004-02-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004
Reference Type:
other: Expert report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Inadequate documentation
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Inadequate documentation
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-acetyl-4-(4-hydroxyphenyl)piperazine
EC Number:
267-744-8
EC Name:
1-acetyl-4-(4-hydroxyphenyl)piperazine
Cas Number:
67914-60-7
Molecular formula:
C12H16N2O2
IUPAC Name:
1-[4-(4-hydroxyphenyl)piperazin-1-yl]ethan-1-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: JNJ-119379-AAA (T001141)
- Physical state: solid (powder)
- Appearance: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 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): no data


VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): no data
- Purity: no data
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after administration
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data


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


SCORING SYSTEM:
Draize System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
8
Remarks on result:
other: Mild irritant
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 136
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 135
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 134
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 136
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 135
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 134
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: male
Irritant / corrosive response data:
Very slight erythema was noted at one treated skin site at the 24 and 48 hour observations. Two treated skin sites appeared normal throughout the study.

Any other information on results incl. tables

Expert conclusion from expert report:

Three animals were observed for skin irritation after a dermal application of the test substance. For each of the three test animals the average scores for three consecutive days (usually 4, 48 and 72 hours) were calculated separately for oedema and erythema. Due to the fact that the cut-off value defined in the criteria of the GHS regulation (i.e. 1.5) was not reached for at least two animals out of three, the substance is not considered as a skin irritant according to the new guidelines.

For this reason it was decided to not classify the test item as a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be a mild irritant to rabbit skin. However, according to criteria of the CLP Regulation, T001141 is not considered as a skin irritant.