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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
other: No abnormalities were observed in males and females.
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.