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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Tthe test material was not moistened to ensure good skin contact. Furthermore, only two animals were included in the study.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

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

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: 2.39 - 2.42 kgNo further information is provided on test animals and environmental conditions.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE- Preparation of test site: rabbits had their trunk clipped 24 hours prior to dosing- Amount of test material applied: a single application of 2000 mg/kg of neat test material was applied to the test site on each rabbit- Type of wrap if used: the applied test material was covered with an elastic rabbit jacketREMOVAL OF TEST SUBSTANCE- Washing (if done): residual test material was wiped off when the bandage was removed- Time after start of exposure: 24 hours after application

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of weighing: animals were weighed on test days 1, 2, 8 and 15- Necropsy of survivors performed: no data- Other examinations performed: clinical signs and dermal irritation

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Neither of the animals died during the study.

Clinical signs:

other: No clinical signs of systemic toxicity were observed during the study.

Other findings:

No signs of dermal irritation were noted during the study.

Any other information on results incl. tables

Table 1: Individual Body Weights (kg)

Animal no.	Test day
	1	2	8	15
1	2.39	2.46	2.57	2.62
2	2.42	2.42	2.61	2.67

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 acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg. As such, the test material requires no classification in accordance with EU criteria.

Executive summary:

The acute dermal 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 402.

A single application of 2000 mg/kg of neat test material was applied to the clipped trunks of 2 female New Zealand White rabbits and covered with an elastic rabbit jacket. Residual test material was wiped off when the bandage was removed 24 hours after application. Both animals survived the test period and both gained weight during the study. No clinical signs of systemic toxicity or dermal irritation were observed.

Therefore, under the conditions of the study, the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg. As such, the test material requires no classification in accordance with EU CLP criteria.