Registration Dossier

Diss Factsheets

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: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2001-12-17
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxybenzamide
- Analytical purity: 97.4% w/w
- Physical state: white powder
- Lot/batch No.: 08466/0013

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Test Animals
TEST ANIMALS
-Source: Harlan/Winkelmann, Borden, Germany
-Age at study initiation: approx. 10 -14 weeks
-Body weight at study initiation: 161 g - 177 g (167 ± 6.4 g)
-Fasting period before dosing: approx. 16 - 24 h before administration of the test compound, and approx. 2 - 4 h after administration .
-Diet: standard diet "Provimi Kliba 3883.0.15 Maus/Ratte Haltung. Nutritive composition and the contaminant content checked and analyzed routinely, ad libitum.
Water: tap water was of drinking water quality, ad libitum
Acclimitazation period: at least 5 days
Housing: Group caged conventionally in polycarbonate cages on low dust wood granulate bedding
ENVIRONMENTAL CONDITIONS
Temperature : 22 ± 2 °C
Air humidity : 55 ± 5%
Ventilation : approx. 10 air changes per hour
Light/ Dark cycle : 12/12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tap water with the aid of 2% Cremophor EL
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In accordance with procedure described in the flow charts of
Annex 2, OECD guideline 423, three animals are used for each step. The dose level to be used as the starting dose is selected from one of four fixed levels, 5, 50, 300 and 2000 mg/kg body weight, for this study 2000 mg/kg bw
The starting dose level should be that which is most likely to produce mortality in
some of the dosed animals. Absence or presence of compound-related mortality of
the animals dosed at one step will determine the next step, i.e.:
• no further testing is needed,
• dosing of three additional animals, with the same dose,
• dosing of three additional animals at the next higher or the next lower dose level.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 + 3) female
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of
administration and subsequently at least once daily. Weight gain of the animals was checked weekly
- Necropsy of survivors performed: yes, gross examination or organs and tissues at necropsy
-Other examinations performed: nature, duration and intensity of clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
There were no deaths during the study period
Clinical signs:
No clinical signs of toxicity were observed during the 14-day observation period
Body weight:
No toxicological effects on body weight or bodyweight gain.
Gross pathology:
Necropsies performed at the end of the study revealed no specific or treatment-related findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified