4(3H)-Pyrimidinone, 2-ethoxy-6-hydroxy-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles but with incomplete reporting. It is considered adequate for classification and labelling purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was administered as a single limit dose via gavage to three female Fischer 344 rats. Animals were observed for two weeks post-exposure.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxy-6-hydroxy-3,4-dihydropyrimidin-4-one

EC Number:

612-185-0

Cas Number:

61636-08-6

Molecular formula:

C6H8 N2 O3

IUPAC Name:

2-ethoxy-6-hydroxy-3,4-dihydropyrimidin-4-one

Test material form:

other: solid (unspecified)

Details on test material:

- Appearance: light tan solid

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Average weight of 139.2 g on day 1 of the study (range: 137.1 - 140.6 g)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % methocel

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs and bodyweight. Bodyweights were reported on days 1, 2, 8 and 15.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Clinical signs on the day of dosing consisted of loose stool, faecal soiling and salivation (signs were observed three hours post-dosing). Faecal soiling continued through test day three. The animals appeared normal from test day six through the remainder

Any other information on results incl. tables

Table 1: Summary of Bodyweight Data (g)

Animal Number	Test Day
	1	2	8	15
93A5525	137.1	149.9	148.2	156.0
93A5526	139.8	153.5	157.8	163.9
93A6462	140.6	152.4	158.5	164.2

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg and as such the test material requires no classification in accordance with EU criteria.

Executive summary:

The acute oral toxicity of the test material was investigated in female Fischer 344 rats.

Three rats received a limit dose of 2000 mg/kg of the test material as a 20 % suspension in 0.5 % methocel by single-dose oral gavage. The animals were observed for two weeks post-exposure.

Clinical signs on the day of dosing consisted of loose stool, faecal soiling and salivation (signs were observed three hours post-dosing). Faecal soiling continued through test day three. The animals appeared normal from test day six through the remainder of the two week observation period. Administration of the test material had no effect on bodyweight.

Under the conditions of this study, the estimated acute oral LD50 for female Fischer 344 rats was greater than 2000 mg/kg and as such the test material requires no classification in accordance with EU criteria.