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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 October 1983 to 19 October 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
12 May 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP statement dates to Dec 18, 1987 QA statement dates to Nov 8, 1983
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
EC Number:
617-441-5
Cas Number:
83121-18-0
Molecular formula:
C14 H6 Cl2 F4 N2 O2
IUPAC Name:
1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
Test material form:
solid

Test animals

Species:
rat
Strain:
other: KFM-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: males: 7 weeks, females: 9 weeks
- Weight at study initiation: males: 203 - 220 g, females: 166 - 180 g
- Housing: animals were caged individually in makrolon type-2 cages with wire mesh lids
- Diet: ad libitum, pelleted standard Kliba 343, rat maintenance diet (Klingentalmuehle AG, CH 4303 Kaiseraugst/Switzerland)
- Water: ad libitum, tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 20 cm² on the shaved back
- Type of wrap: adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: skin was cleaned with lukewarm water
- Time after start of exposure: after 24 hours

TEST MATERIAL
- Amount applied: suspension of 5 mL at 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2000 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 and weighing: Mortality was observed 5 times during day 1 and daily thereafter, body weights were recorded at the day of administration and days 8 and 15 of the test, Symptoms were observed 5 times at day 1 and daily for the nature, onset, severity and duration of toxic effects
- Necropsy of survivors performed: yes

Statistics:
The LOGIT Model could not be applied to the observed rates of death. The LD50 was estimated without use of a statistical model.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
other: No toxic symptoms were observed during the observation period.
Gross pathology:
No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met