Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate

EC Number:

406-600-2

EC Name:

Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate

Cas Number:

89392-03-0

Molecular formula:

C13H13N3O4

IUPAC Name:

phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate

Test material form:

solid: crystalline

Details on test material:

- Identification: IN-E6758
- Description: Off white to light blue solid
- Batch: E52691-89-3-B22
- Purity: approx. 100%
- Expiry date: not indicated
- Storage: at room temperature in a cool place in the dark (avoid high temperatures)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 196 - 209 g / females: 156 - 176 g
- Fasting period before study: overnight prior to dosing
- Housing: group housing of 5 animals per sex per cage in polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet (Kliba 343 from KlingentalmOhle AG, Kaiseraugst, Switzerland).
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 55%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours artificial light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

prepared by reverse osmosis

Details on oral exposure:

The formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test substance in vehicle was obtained by stirring and shaking. The dose volume was 20 ml/kg body weight.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals per sex

Control animals:

no

Details on study design:

Duration of observation period following administration:
- mortality: at periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
- body weights: days 1, 8 and 15
- symptoms: at periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

not performed

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 5000 mglkg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mglkg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No signs of toxicity were observed.

Gross pathology:

No treatment-related macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity LD50 on rats was found to be > 5000 mg/kg.

Executive summary:

The study was performed according to the standard method EU B.1 on Wistar rats with a single dose of 5000 mg/kg. Five animals were used per sex. The animals were treated orally by gavage with an aqueous suspension of the the test material. The LD50 was determined to be > 5000 mg/kg; therefore, the test item does not have any classification/labelling requirements.