1-acetyl-4-(4-hydroxyphenyl)piperazine

Skin irritation / corrosion

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Reference 2

Reference Type:

other: Expert report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Inadequate documentation

Test guideline 2

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

Test material information

Constituent 1

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-acetyl-4-(4-hydroxyphenyl)piperazine

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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.