4(3H)-Pyrimidinone, 2-ethoxy-6-hydroxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles but with incomplete reporting. It is considered adequate for classification and labelling purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was applied topically to intact and abraded skin on the shaved abdomen of two male New Zealand White rabbits, one under dry conditions and the other under wet conditions in an occlusive fashion for 24 hours. Five consecutive daily doses were applied to the intact skin and three consecutive daily applications were made to the abraded abdominal site.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxy-6-hydroxy-3,4-dihydropyrimidin-4-one

EC Number:

612-185-0

Cas Number:

61636-08-6

Molecular formula:

C6H8 N2 O3

IUPAC Name:

2-ethoxy-6-hydroxy-3,4-dihydropyrimidin-4-one

Test material form:

other: solid (unspecified)

Details on test material:

- Appearance: light tan solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Average weight of 3.33 kg on day 1 of the study (range: 3.29 - 3.37 kg).

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material was applied to both the intact and abraded sites under wet and dry conditions. To ensure sufficient contact of the test material with the skin, 0.4 mL of distilled water was used to moisten the test material for the wet patch application.

Duration of treatment / exposure:

24 hours per application.
Five consecutive daily doses of test material were applied to the intact skin, and three consecutive daily applications were made to the abraded abdominal sites.

Observation period:

Not reported

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: Abdomen. The abdomen of each rabbit was shaved with a straight razor at least three days prior to test initiation.
- Type of wrap if used: The animals were bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site.

SCORING SYSTEM: Not reported. Twenty four hours after application the bandages were removed and the application sites were graded.

Results and discussion

In vivo

Irritant / corrosive response data:

Very slight erythema was observed at both the intact and abraded sites on the wet patch animal. Slight erythema was observed at the abraded application site only for the dry patch animal.

Other effects:

No mortality was observed. No clinical signs indicative of systemic toxicity were observed. No substantial weight change was noted over the duration of the study (Table 1).

Any other information on results incl. tables

Table 1 Summary of Bodyweight Data (kg)

Animal Number	Test Day
	1	8
93A0095 (Dry patch)	3.37	3.22
93A2423 (Wet patch)	3.29	3.18

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Very slight erythema was observed at both the intact and abraded sites on the wet patch animal. Slight erythema was observed at the abraded application site only for the dry patch animal.
Although the observations were not scored in the usual manner for this type of study the available evidence suggests that it is not necessary to classify the substance as a skin irritant.

Executive summary:

The skin irritation potential of the test material was investigated in the New Zealand White rabbit.

0.5 g of the test material was applied topically to intact and abraded skin on the shaved abdomen of two male rabbits, one under dry conditions and the other under wet conditions in an occlusive fashion for 24 hours. Five consecutive daily doses were applied to the intact skin and three consecutive daily applications were made to the abraded abdominal site.

No mortality was observed. No clinical signs indicative of systemic toxicity were observed. No substantial weight change was noted over the duration of the study.

Very slight erythema was observed at both the intact and abraded sites on the wet patch animal. Slight erythema was observed at the abraded application site only for the dry patch animal.

Although the observations were not scored in the usual manner for this type of study the available evidence suggests that it is not necessary to classify the substance as a skin irritant.