Benzamide, 4-methoxy-N-[2-nitro-4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP condidtions according to OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

4-methoxy-N-[4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-2-nitrophenyl]benzamide

EC Number:

616-053-3

Cas Number:

74149-73-8

Molecular formula:

C19 H18 N4 O5

IUPAC Name:

4-methoxy-N-[4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)-2-nitrophenyl]benzamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Nitropyridazinon synonymous to "Stufe, UDCG 115"
- Physical state: solid
- Analytical purity: 99.0 %
- Purity test date: 02 August 2001
- Lot/batch No.: RH 1/1 - 1/23
- Expiration date of the lot/batch: August 2002
- Storage condition of test material: at room temperature, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH; D-33178 Borchen
- Weight at study initiation: male 155 -161 g ; female 144 - 148
- Fasting period before study: overnight prior tor dose administration
- Housing: The animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Feeding ad libitum Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free-TPF
- Water (e.g. ad libitum): Free access to tap water ( drinking water, municipal residue control, microbiol. controlled periodically )
- Acclimation period: adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 : 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : clinical signs - twice a day on day of dosing and once a day thereafter
body weight - prior to first application and once a week thereafter
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No Mortality

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period.

Gross pathology:

Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in all animals of step 1 and step 2.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" has no acute toxic characteristics.
The LD50 was determined to be > 2000 mg/kg bw.

Executive summary:

The acute toxic class method was performed with Nitropyridazinon synonymous to "Stufe, UDCG 115" . It is the principal of the acute toxic class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item to enable its classification.

In the first step the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" was given in a dose of 2000 mg/kg body weight to a group of 3 male rats in a single exposure via oral gavage. In a second step the test item was given to 3 female rats in a single exposure via oral gavage.

The dosage of 2000 mg/kg body weight caused no compound-related mortality neither in the three male nor in the three female animals within the 14 days p. appl..

A careful clinical examination was made once a day. At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes. No clinical signs of toxicity were observed throughout the observation period.

Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in all animals of step 1 and step 2.

Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" is provided.

According to the results obtained the LD50 was determined to be > 2000 mg/kg bw.

Considering the reported data of this toxicity test it can be stated that the test item Nitropyridazinon synonymous to "Stufe, UDCG 115" has no acute toxic characteristics.