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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
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.