Benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Feb - 15 Mar 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17 Dec 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-320-2

EC Name:

-

Cas Number:

221667-31-8

Molecular formula:

C18H18N205S

IUPAC Name:

N-[4-(cyclopropylcarbamoyl)benzenesulfonyl]-2-methoxybenzamide

Test animals

Species:

rat

Strain:

other: Wistar HsdCpb:Wu

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/Winkelmann, Borden, Germany.
- Females nulliparous and non-pregnant: yes
- 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
- 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:

no

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 of organs and tissues at necropsy.
- Clinical signs including body weight: Yes, nature, duration and intensity of clinical signs and body weight measurements.

Results and discussion

Effect levels

Key result

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:

other: No clinical signs of toxicity were observed during the 14-day observation period

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:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The study was performed in accordance to OECD TG 423 under GLP conditions and is considered reliable. The LD50 was determined to be ≥ 5000 mg/kg bw (LD50 cut-off of value).