Registration Dossier

Diss Factsheets

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:
1989
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

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: 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:
No abnormalities were observed in males and females.
Body weight:
Body weight gain was in the expected range for males and females. At 7 days post dose, mean body weight was 306 g for males and 245 g for females. At 13 days post dose, mean body weight was 335 g for males and 256 g for 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.