4H-Pyrido[1,2-a]pyrimidin-4-one, 9-hydroxy-3-(2-hydroxyethyl)-2-methyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-06-02 to 2003-07-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

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.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: SPL Standard Test Method 520.01

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:

9-hydroxy-3-(2-hydroxyethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

EC Number:

605-935-3

Cas Number:

181525-38-2

Molecular formula:

C11H12N2O3

IUPAC Name:

9-hydroxy-3-(2-hydroxyethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

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: 30-38 g
- Fasting period before study: Animals were fasted before treatment. No further data 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:

water

Remarks:

distilled water

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 (two groups); 2000 mg/kg bw (two groups). Dosing was performed subsequently.

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:

> 1 000 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Three animals treated at a dose level of 2000 mg/kg bw were found dead 30 min after dosing. No death cases were reported for animals treated with 300 mg/kg bw .

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The body weight was within normal range of variability.

Gross pathology:

No abnormalities were observed in all animals treated with 300 mg/kg bw and four animals treated with 2000 mg/kg bw. Two animals treated with 2000 mg/kg bw had lungs abnormally red, liver patchy pallor, and one of them had a white material present in the stomach.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50 of the test substance in the female outbred albino mouse is estimated to be in the range of 1000-2000 mg/kg bodyweight. Based on expert judgement it is concluded that since only 300 and 2000 mg/kg were tested in this study, it cannot be estimated that the LD50 is situated in the range 1000-2000 mg/kg according to the guidelines. T002416 is classified as acute tox. Cat. 4 according to the criteria of the CLP regulation (EC) 1272/2008.