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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.