Benzonitrile, 4-[(4-chloro-2-pyrimidinyl)amino]-

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-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE

EC Number:

607-384-4

Cas Number:

244768-32-9

Molecular formula:

C11H7ClN4

IUPAC Name:

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

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study reports): JNJ-4754724-AAA (T002488)
- Physical state: solid
- Appearance: light brown powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No data
- Expiration date of the lot/batch: No data
- Purity test date: No data

Test animals

Species:

mouse

Strain:

other: Outbred albino

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: 20-24 g
- Fasting period before study: Yes, fasting period not provided.
- 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

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; 2000 mg/kg bw (two groups) stepwise procedure

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: mortality and clinical signs were observed 30 minutes, 1, 2, 3, and 4 hours after dosing, and daily for 14 days after dosing. Body weights were recorded on days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight, and macroscopic examinations.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities were reported for the tested concentrations.

Clinical signs:

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

Gross pathology:

No abnormalities were found during the necropsy observations.

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 2000 mg/kg bodyweight.