4-[(4-HYDROXYPYRIMIDIN-2-YL)AMINO]BENZONITRILE

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-11-10 to 2004-12-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

modified on 2001-12-17

Deviations:

yes

Remarks:

: 1) no characterization of the test material; 2) not sufficient data for the animals tested.

GLP compliance:

no

Remarks:

The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-[(4-Oxo-1,4-dihydropyrimidin-2-yl)amino]benzonitrile

EC Number:

606-195-4

Cas Number:

189956-45-4

Molecular formula:

C11H8N4O

IUPAC Name:

4-[(4-Oxo-1,4-dihydropyrimidin-2-yl)amino]benzonitrile

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): JNJ-40370226-AAA (T002487)
- Physical state: solid (powder)
- Appearance: Off-white powder

Specific details on test material used for the study:

- Name of test material (as cited in study report): T2487

Test animals

Species:

mouse

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 19-23 g
- Fasting period before study: Animals were fasted before treatment, however, fasting period data were not available.
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data


IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE: no data

MAXIMUM DOSE VOLUME APPLIED: no data


DOSAGE PREPARATION (if unusual): no data


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: advised in OECD-423 guideline

Doses:

300 mg/kg bw (one group); 2000 mg/kg bw (two groups). Dosing was performed sequentially.

No. of animals per sex per dose:

3 females/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: no data
- Clinical signs: yes
- Body weight: yes
- Organ weights: no
- Histopathology: no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

No mortalities were reported for the tested concentrations.

Clinical signs:

No signs of systemic toxicity were reported for the tested concentrations.

Body weight:

The bodyweight was within the normal range of variability.

Gross pathology:

No abnormalities were detected in macroscopic observations at 300 and 2000 mg/kg bw dose levels.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test substance in the female outbred albino mouse is estimated to be greater than 2500 mg/kg bodyweight.