Pyrimidine, 5-fluoro-4-hydrazinyl-2-methoxy-

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:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in accordance with generally accepted scientific principles; however full data on methodology is not given and no information relating to GLP status is provided. An accurate assessment of the study is therefore not considered to be possible.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

0.5 g of test material was applied in an occlusive fashion to intact and abraded skin on the abdomen of two rabbits, one under dry conditions (unchanged test material) and the other under wet conditions (test material moistened with 1.0 mL of water). Twenty four hours after application the bandages were removed and the application sites were graded. Five consecutive daily doses of test material were applied to the intact skin sites, and three consecutive daily applications were made to the abraded skin sites. Skin irritation was assessed and body weight measurements were recorded.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

5-fluoro-4-hydrazinyl-2-methoxypyrimidine

EC Number:

605-444-4

Cas Number:

166524-64-7

Molecular formula:

C5H7FN4O

IUPAC Name:

5-fluoro-4-hydrazinyl-2-methoxypyrimidine

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): 5-fluoro-4-hydrazino-2-methoxypyrimidine- Physical state: 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: 3.338 - 3.434 kgNo further information is provided on test animals and environmental conditions.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

other: Animal 1 (dry conditions): unchanged (no vehicle); Animal 2 (wet conditions): test material moistened with 1.0 mL water

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

Each application of test material was held in contact with the skin for a period of 24 hours.Five consecutive daily doses of test material were applied to the intact skin sites, and three consecutive daily applications were made to the abraded skin sites.

Observation period:

7 days

Number of animals:

Two males

Details on study design:

TEST SITE- Area of exposure: intact and abraded skin on the abdomen. The abdomen of each rabbit was shaved with a straight razor at least 3 days prior to test initiation.- Type of wrap if used: occlusive. The animals were bandaged to provide occlusion and prevent grooming of the application site.SCORING SYSTEMTwenty four hours after each application the bandages were removed and the application sites were graded.

Results and discussion

In vivo

Irritant / corrosive response data:

Application of the test material did not cause dermal irritation.

Other effects:

No substantial weight change occurred during the study (see Table 1).

Any other information on results incl. tables

Table 1: Individual Body Weights (kg)

Animal	Test day
	1	8
1 (dry conditions)	3.338	3.193
2 (wet conditions)	3.434	3.301

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material did not evoke any reaction in either of the test animals. Therefore it is considered that the test material does not require classification 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 in an occlusive fashion to intact and abraded skin on the abdomen of two male rabbits, one under dry conditions (unchanged test material) and the other under wet conditions (test material moistened with 1.0 mL of water). Twenty four hours after application the bandages were removed and the application sites were graded. Five consecutive daily doses of test material were applied to the intact skin sites, and three consecutive daily applications were made to the abraded skin sites. Skin irritation scores and body weight measurements were recorded.

Under the conditions of the study, the test material did not evoke any reaction in either of the test animals. Therefore it is considered that the test material does not require classification as a skin irritant under the EU CLP criteria.