(+-)-2,4-dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2005-01-27 to 2005-01-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Non-GLP study according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion). Limited information available on test item and test system.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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-(butan-2-yl)-4-{4-[4-(4-methoxyphenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

EC Number:

607-685-0

Cas Number:

252964-68-4

Molecular formula:

C23H29N5O2

IUPAC Name:

1-(butan-2-yl)-4-{4-[4-(4-methoxyphenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): JNJ-7982559-AAA (T001329)
- Physical state: solid (powder)
- Appearance: Grey-brown powder

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:
- Three male New Zealand White rabbits, nu further data on animals

ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: no data

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE: no data

REMOVAL OF TEST SUBSTANCE: no data

OBSERVATION TIME POINTS
- Skin reactions were recorded 1, 24, 48 and 72 hours after administration

SCORING SYSTEM:
- Skin reactions were scored according to Draize
- Primary Irritation Index
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:

erythema score

Basis:

mean

Remarks:

animal 158

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 159

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 160

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 158

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 159

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 160

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Irritation/corrosion scores were 0.0 for erythema/eschar formation and edema formation for all animals at all time points examined. No evidence of skin irritation was noted.

Any other information on results incl. tables

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		158 Male	159 Male	160 Male
Erythema/Eschar Formation	1 Hour	0	0	0	(0)
	24 Hour	0	0	0	0
	48 Hour	0	0	0	(0)
	72 Hour	0	0	0	0
Oedema Formation	1 Hour	0	0	0	(0)
	24 Hour	0	0	0	0
	48 Hour	0	0	0	(0)
	72 Hour	0	0	0	0
Sum of 24 and 72 Hour Readings					0
Primary Irritation Index (S/6) and Classification					0/6=0
					Non-Irritant

( ) = 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 not irritating to rabbit skin under the conditions of the study.