Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-935-0 | CAS number: 598-50-5
Acute Toxicity: oral
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:
- 1 986
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
