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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methylurea
EC Number:
209-935-0
EC Name:
Methylurea
Cas Number:
598-50-5
Molecular formula:
C2H6N2O
IUPAC Name:
methylurea
Details on test material:
- Name of test material (as cited in study report): Methylharnstoff, technisch (methylurea, technical grade)
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K . THOMAE GMBH, BIBERACH, GERMANY
- Age at study initiation: No data
- Mean weight at study initiation: males: 208 g; females: 188 g (both ± 20 % OF THE MEAN WEIGHT)
- Fasting period before study: 16 hours before administration no feed was given; water was available ad libitum.
- Housing: 5 animals per cage STAINLESS STEEL WIRE MESH CAGES, TVPE DK-III.
- Diet (e.g. ad libitum): KLIBA LABORDIAET, FA. KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, ad libitum
- Water: TAP WATER, ad libitum
- Acclimation period: AT LEAST 1 WEEK

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % (w/v)
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: No data

- Rationale for the selection of the starting dose: limit test
Doses:
5000 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
- Frequency of observations: recording of signs and symptoms several times on the day of administration; afterwards at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Frequency of observations and weighing: before study initiation and on day 7 and 14
- Necropsy of survivors performed: yes. 16 hours before to the end of the observation period food was withdrawn and surviving animals were sacrificed with CO2.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No mortality, no symptoms
Mortality:
No mortality observed.
Clinical signs:
No abnormalities were observed in males and females.
Body weight:
Body weight gain was in the expected range for males and females.
Males: Beginning of the study: 208 g, day 7: 260 g, day 13: 282 g;
Females: Beginning of the study: 188 g, day 7: 218 g, day 13: 226 g;
Gross pathology:
No abnormalities were observed in the organs of males and females.
Other findings:
No other findings.

Applicant's summary and conclusion

Conclusions:
Based on the results of this study, the test substance does not have to be classified according to 67/548/EEC and Regulation (EU) No. 1272/2008.