4-[(4-HYDROXYPYRIMIDIN-2-YL)AMINO]BENZONITRILE

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-11-10 to 2004-11-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Study is conducted according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); however, the test substance is not adequately characterized and insufficient information is provided on the test animals.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: Insufficient information on the test substance and test animals.

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

: Insufficient information on the test substance and test animals.

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

4-[(4-Oxo-1,4-dihydropyrimidin-2-yl)amino]benzonitrile

EC Number:

606-195-4

Cas Number:

189956-45-4

Molecular formula:

C11H8N4O

IUPAC Name:

4-[(4-Oxo-1,4-dihydropyrimidin-2-yl)amino]benzonitrile

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): JNJ-40370226-AAA (T002487)
- Physical state: solid (powder)
- Appearance: Off-white 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:
- source: 3 male NewZealand White Rabbits, no further data on test animals

ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact

Vehicle:

not specified

Controls:

other: Untreated skin areas of the test animals served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data

VEHICLE: no data

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: semi-occlusive, no further data

REMOVAL OF TEST SUBSTANCE: no data

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

SCORING SYSTEM:
- 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:

animal: 61

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal: 67

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal: 68

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

edema score

Basis:

animal: 61

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal: 67

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal: 68

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

An isolated incidence of very slight erythema was noted at one treated skin site at the 24-hour observation.

Any other information on results incl. tables

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		61 Male	67 Male	68 Male
Erythema/Eschar Formation	1 Hour	0	0	0	(0)
	24 Hour	0	0	1	1
	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					1
Primary Irritation Index (S/6) and Classification					1/6=0.2
					Mild 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 found to be a mild irritant with a primary irritation index of 0.2. Based on the criteria of the CLP regulation (EC) No 1272/2008, the test item is considered not to be classified (score < 2.3).