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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

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:

rat

Strain:

Fischer 344

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: 155.4 - 252.6 gNo further information is provided on test animals and environmental conditions.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test material was administered as a 1, 10 or 20 % suspension in water by single dose oral gavage.

Doses:

50, 100, 500, 1000 or 2000 mg/kg

No. of animals per sex per dose:

3 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of weighing: surviving animals were weighed on test days 1, 2, 8 and 15- Necropsy of survivors performed: no data- Other examinations performed: clinical observations were recorded during the 14 day observation period

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

100 - 500 mg/kg bw

Based on:

test mat.

Mortality:

All animals dosed at 500 mg/kg and above died on the day of dosing while all animals dosed at 50 or 100 mg/kg survived the 14 day observation period.

Clinical signs:

other: Clinical observations in animals dosed at 2000 mg/kg consisted of convulsions and tremors. Clinical observations in animals dosed at 1000 mg/kg consisted of salivation, incoordination and convulsions. Clinical observations in animals dosed at 500 mg/kg co

Any other information on results incl. tables

Table 1: Individual Body Weights (grams)

Dose (mg/kg)	Test day
	1	2	8	15
50	160.8	180.3	207.8	233.7
	162.2	183.5	204.7	214.8
	169.0	185.6	211.0	230.8
100	166.5	185.5	213.0	236.8
	162.9	180.7	197.1	213.0
	160.4	181.4	198.3	214.4
500	163.3	***	***	***
	157.7	***	***	***
	159.3	***	***	***
1000	159.3	***	***	***
	155.4	***	***	***
	160.8	***	***	***
2000	252.6	***	***	***
	245.8	***	***	***
	198.5	***	***	***

*** No data, dead animal

Applicant's summary and conclusion

Interpretation of results:

other: Category 3

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for male Fischer 344 rats was estimated to be between 100 and 500 mg/kg. It is therefore considered that the test material requires classification as Category 3 for acute oral toxicity in accordance with EU CLP criteria.

Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted to a method similar to that which is outlined in standardised guideline OECD 401.

During the study, groups of 3 male rats each received 50, 100, 500, 1000 or 2000 mg/kg test material, as a 1, 10 or 20 % suspension in water, by single oral gavage. Clinical observations and body weight measurements were recorded during the 14 day observation period.

All animals dosed at 500 mg/kg and above died on the day of dosing while all animals dosed at 50 or 100 mg/kg survived the 14 day observation period.

Clinical observations in animals dosed at 2000 mg/kg consisted of convulsions and tremors. Clinical observations in animals dosed at 1000 mg/kg consisted of salivation, incoordination and convulsions. Clinical observations in animals dosed at 500 mg/kg consisted of salivation, incoordination, blood on the muzzle and convulsions. There were no significant clinical observations recorded in animals dosed at 50 or 100 mg/kg.

All surviving animals gained weight by the end of the 14 day observation period.

Under the conditions of this study, the acute oral LD50 for male Fischer 344 rats was estimated to be between 100 and 500 mg/kg. It is therefore considered that the test material requires classification as Category 3 for acute oral toxicity in accordance with EU criteria.