Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, guideline-conform study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one
EC Number:
230-625-6
EC Name:
Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one
Cas Number:
7226-23-5
Molecular formula:
C6H12N2O
IUPAC Name:
tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one
Test material form:
other: liquid
Details on test material:
Name of the test substance used in the study report: N,N'-Dimethylpropylenharnstoff

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Five animals per cage were housed in stainless steel wire mesh cages. The animals were held in fully air-conditioned rooms with a central air conditioning in a range of 20 - 24°C and a relative humidity between 30 - 70%. The day/night rhythm was 12 h light and 12 h dark. The rats were identified using cage cards. A standardized rat feed diet and tap water were available ad libitum. The animals were given no feed about 16 h before administration; water was available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
681, 1470, 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Recording of signs and symptoms were done several times on the day of administration (at least once each working day). A check for moribund and dead rats were made twice each working day and once on public holidays.
Withdrawal of food about 15 hours before sacrifice with CO2; necropsy with gross-pathological examination. Necropsy was done of all a nimals that die as early as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 770 mg/kg bw
Based on:
test mat.
Mortality:
Male animals: 681 and 1470 mg/kg: no mortalities after 14 days. 2000 mg/kg: 4/5 after 14 days.
Female animals: 681 mg/kg: no moralities after 14 days. 1470 mg/kg: 1/5 after 14 days. 2000 mg/kg: 4/5 after 14 days.
Clinical signs:
other: Dyspnea, apathy, staggering, twitching, piloerrection, cyanosis (males only), impaired general state (females only) poor general state.
Gross pathology:
Animals that died: general congestion; lungs: intensified hyperemia in few animals.
Sacrificed animals: nothing abnormal detected.

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information