Registration Dossier
Registration Dossier
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EC number: 209-935-0 | CAS number: 598-50-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- BASF test
- 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: 279 g; females: 239 g (both ± 20 % OF THE MEAN WEIGHT, Range 200 - 300 g)
- Housing: 1 animal 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
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk, clipped epidermis
- Area of application: unknown; in the report a application area of about 50 x 50 cm was given, which was not comprehensible.
- % coverage: unknown
- Type of wrap if used: porous dressing (four layers absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing of the application site with warm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 50 w/v
- Constant volume or concentration used: yes
- For solids, paste formed: no, solution was applied
VEHICLE
- Amount(s) applied (volume or weight with unit): 4mL/kg
- Concentration (if solution): 50 w/v - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clipping: at least 15 hours before beginning of the study
- 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. Necropsy of all animals that died as early as possible.
- Scoring of skin findings: 30 - 60 minutes after removal of the semiocclussive dressing and then about one week later and before termination of the study. - Statistics:
- No statistics were performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortality
- Mortality:
- No deaths occurred throughout the study.
- Clinical signs:
- other: No abnormalities were observed in males and females.
- Gross pathology:
- No abnormalities were observed in males and females.
- Other findings:
- No local abnormalities were observed in males and females.
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.
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