6-ethyl-5-fluoro-4(3H)-pyrimidone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1996-05-29 to 1996-06-1

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

OJ No. L383A, 29.12.92

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-ethyl-5-fluoro-4(3H)-pyrimidone

EC Number:

422-460-5

EC Name:

6-ethyl-5-fluoro-4(3H)-pyrimidone

Cas Number:

137234-87-8

Molecular formula:

C6 H7 F N2 O

IUPAC Name:

6-ethyl-5-fluoro-3,4-dihydropyrimidin-4-one

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch No.: Chichibu Lot No. 950704
Purity: 95.7%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England.
- Age at study initiation: approximately 11 to 14 weeks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: A standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Ca 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
A 0.5 g amount of the test substance was applied under a 25 mm x 25 mm gauze pad which had been moistened with 0.5 mL distilled water to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30 to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
- Clinical signs: daily
- Dermal responses: on Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: for all three animal tested

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: for all three animal tested

Irritant / corrosive response data:

No dermal response to treatment was observed in any animal throughout the observation period.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Individual scores:

Animal No.	Erythema				Oedema
	24 h	48h	72 h	Mean	24 h	48h	72 h	Mean
1	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A single semi-occlusive application of test item to intact rabbit skin for four hours elicited no dermal irritation.

Executive summary:

A study was performed to assess the skin irritation potential of test item to the rabbit following the method described in EC B.4.

Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days.

No reactions were observed following a single semi-occlusive application of test item to intact rabbit skin for four hours.