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

Eye irritation

Administrative data

Endpoint:

eye 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. Furthermore it is not possible to determine the classification of the test material based upon the data provided.

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:

0.1 g of test material was instilled into each conjunctival sac of one rabbit that had been screened for ocular defects and irritation 24 hours prior to dosing. One eye was washed with water after a 30 second exposure, while the other eye was washed after one hour of exposure. Signs of ocular irritation were recorded over a period of 7 days following test material administration. Body weight was recorded on test day 1 and test day 4.

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Weight at study initiation: 3.18 kgNo further information is provided on test animals and environmental conditions.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

One eye was washed after a 30 second exposure, while the other eye was washed after one hour of exposure.

Observation period (in vivo):

Signs of ocular irritation were recorded over a period of 7 days following test material administration.

Number of animals or in vitro replicates:

1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing (if done): washed with water.- Time after start of exposure: one eye was washed after 30 seconds of exposure and the other was washed after one hour of exposure.

Results and discussion

In vivo

Irritant / corrosive response data:

Moderate pain was noted in the eyes of the rabbit immediately after dosing. Very slight to slight conjunctival inflammation was present in the eyes 1 hour after dosing. Slight to moderate conjunctival inflammation was present 24 hours after dosing. The conjunctival inflammation gradually diminished, and was resolved by 7 days after dosing.

Other effects:

The rabbit survived the test period. The animal lost 560 g of body weight during the 7 days after dosing.

Any other information on results incl. tables

Table 1: Individual Body Weight (kg)

Animal	Test day
	1	4
1	3.18	2.62

Applicant's summary and conclusion

Interpretation of results:

other: It is not possible to classify the test material based on the available data

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material induced very slight to moderate conjunctival inflammation over the 7 day observation period. As no information is available on the grade of reaction observed at 24, 48 and 72 hours following test material administration, it is not possible to ascertain a classification for eye irritation.

Executive summary:

The eye irritation potential of the test material was investigated in a study in which 0.1 g of test material was instilled into each conjunctival sac of one female New Zealand White rabbit that had been screened for ocular defects and irritation 24 hours prior to dosing. One eye was washed with water after a 30 second exposure, while the other eye was washed after one hour of exposure. Signs of ocular irritation were recorded over a period of 7 days following test material administration. Body weight was recorded on test day 1 and test day 4.

Moderate pain was noted in the eyes of the rabbit immediately after dosing. Very slight to slight conjunctival inflammation was present in the eyes 1 hour after dosing. Slight to moderate conjunctival inflammation was present 24 hours after dosing. The conjunctival inflammation gradually diminished, and was resolved by 7 days after dosing.

Under the conditions of the study, the test material induced very slight to moderate conjunctival inflammation over the 7 day observation period. As no information is available on the grade of reaction observed at 24, 48 and 72 hours following test material administration, it is not possible to ascertain a classification for eye irritation. As such as endpoint will be considered "data lacking" for classification purposes although the wording of the report suggests that classification of the substance as an eye irritant is probably not required.