6-hydroxy-1H-pyrimidin-4-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-08-07 to 1995-08-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

6-hydroxy-1-H-pyrimidin-4-one

IUPAC Name:

6-hydroxy-1-H-pyrimidin-4-one

Constituent 2

Reference substance name:

6-hydroxy-1H-pyrimidin-4-one

EC Number:

214-772-3

EC Name:

6-hydroxy-1H-pyrimidin-4-one

Cas Number:

1193-24-4

Molecular formula:

C4H4N2O2

IUPAC Name:

6-hydroxypyrimidin-4(3H)-one

Details on test material:

- Substance type: pure active substance
- Physical state: solid, homogeneous brownish-yellow powder

- Impurities (identity and concentrations): water 1.78%

Test animals

Species:

rabbit

Strain:

other: Kleine Weisse Russen, strain Chbb:HM, SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Kleine Weisse Russen, strain Chbb:HM, SPF
- Age at study initiation: adult
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: conventional, individual animals in stainless steel cages
- Diet: ad libitum, Ssniff K 4 Alleindiaet fuer Kaninchen
- Water: communal drinking water ad libitum
- Acclimation period: > 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 1995-08-07 To: 1995-08-11

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

fully deionized

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied (weight with unit): 0.5 g solid test material, finely ground

VEHICLE
- Amount applied (volume with unit): 0.5 cm3 used for wetting the test substance
- Purity: fully deionized water

Duration of treatment / exposure:

4 hours

Observation period:

30-60 min, 24 h, 48 h, and 72 h after removal of patch

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approximately 6cm2
- Type of wrap: gauze patch, held in place with non-irritating tape, semi-occlusive dressing
- Untreated skin serves as control

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: OECD Guideline 404: Table: Grading of skin reactions

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no erythema or eschar formation at any time

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no erythema or eschar formation at any time

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no erythema or eschar formation at any time

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no erythema or eschar formation at any time

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no edema formation at any time

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no edema formation at any time

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no edema formation at any time

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks:

no edema formation at any time

Irritant / corrosive response data:

No signs of dermal irritation were observed 30-60 min after the removal of the patches. Neither were any skin reactions (erythema or edema) found at the later observation time points (24, 48, and 72 hours)

Other effects:

A yellow discoloration of the skin in the application area was seen at all observation times, due to the intrinsic color of the test material

Any other information on results incl. tables

Individual results

Time after patch removal		30-60 min			24 h			48 h			72 h
Animal	1	2	3	1	2	3	1	2	3	1	2	3
Erythema and eschar formation	0	0	0	0	0	0	0	0	0	0	0	0
Edema	0	0	0	0	0	0	0	0	0	0	0	0
Skin discoloration: yellowish	x	x	x	x	x	x	x	x	x	x	x	x

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is considered to be not irritating. The study is considered to be relevant and reliable.