1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-07-07 to 2004-09-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study is similar to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion);

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:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Remarks:

Study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. No formal claim of GLP compliance was made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE

Cas Number:

74852-61-2

Molecular formula:

C17H19N3O3

IUPAC Name:

1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study reports): JNJ-1806792-AAA (T001325)
- Physical state: solid (powder)
- Appearance: brown powder

Specific details on test material used for the study:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

male

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: From: 2003-07-07 To: 2003-07-10

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable

Duration of treatment / exposure:

A single 4 hour treatment

Observation period:

1, 24, 48, and 72 hours

Number of animals:

three male rabbits

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:
Animals were scored on erythema/eschar and oedema formation.
Primary Irritation Index was assigned as follows:
0 = Non-irritant
> 0 - 2 = Mild irritant
>2 - 5 = Moderate irritant
>5 - 8 = Severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

8

Reversibility:

other: Non-irritating so not applicable

Remarks on result:

other: Non-irritant

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 93

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: male

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 94

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 96

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 93

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 94

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 96

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: male

Irritant / corrosive response data:

Non-irritant

Other effects:

Light brown-coloured staining was reported for all (3) test animals.

Any other information on results incl. tables

Skin Reaction	Observation Time	Rabbit 1	Rabbit 2	Rabbit 3	Total
Erythema/ Eschar Formation	1 Hour	0 STA	0 STA	0 STA	( 0 )
	24 Hours	0 STA	0 STA	0 STA	0
	48 Hours	0 STA	0 STA	0 STA	( 0 )
	72 Hours	0 STA	0 STA	0 STA	0
Total		0	0	0	0
Mean Score		0.0	0.0	0.0	0.0
Oedema Formation	1 Hour	0	0	0	( 0 )
	24 Hours	0	0	0	0
	48 Hours	0	0	0	( 0 )
	72 Hours	0	0	0	0
Total		0	0	0	0
Mean Score		0.0	0.0	0.0	0.0
Sum of 24 and 72 Hour Readings (s)					0
Primary Irritation Index (S/6) and Classification					0/6 = 0.0 NON-IRRITANT

 

STA = Light brown-coloured staining

(    ) = Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was found to have a score of 0 for erythema/eschar formation and oedema formation at 1, 24, 48, and 72 hours. The substance was found not to be irritating. The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC.