Benzenebutanoic acid, 4-[(4-methoxybenzoyl)amino]-.beta.-methyl-3-nitro-.gamma.-oxo-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 06 April 1994 to 18 July 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: compliant to GLP; adequate coherence between data, comments and conclusions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

not applicable

Principles of method if other than guideline:

A single oral dose of 5000 mg/kg UD-CG 115 Nitrobenzamid (Gamma-NAP) was given to 3 male and 3 female rats by gavage.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

426-290-2

EC Name:

-

Cas Number:

74149-72-7

Molecular formula:

C20H20N2O7

IUPAC Name:

methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate

Details on test material:

- Name of test material (as cited in study report): UD-CG 115 Nitrobenzamide (Gamma-NAP)
- Physical state: powder
- Substance type: monoconstituent
- Analytical purity: 98.9%
- Lot/batch No.: 1/94
- Purity test date: 04 February 1994
- Expiration date of the lot/batch: February 1996.

Test animals

Species:

rat

Strain:

other: THOM (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH - D-88397 Biberach
- Age at study initiation: 41 days
- Weight at study initiation: 122-154 g
- Housing: Macrolon cages, type III
- Diet (e.g. ad libitum): dry food (Nafag 8577, in pellets)
- Water (e.g. ad libitum): municipal drinking water
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 45% - 75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 9hours /15 hours

IN-LIFE DATES: From: 12 April 1994 To: 25 April 1994.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% natrosol 250 HX (hydroxyethylcellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the overall appearance and behaviour of each animal were observed at least twice a day. On weekends and on non-working days, the animals were controlled once in the morning. Body weight of the animals was determined on the day of administration
(day 1) as well as on days 2, 7 and 14 of the experiment.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study.

Clinical signs:

other: No clinical signs were noted during the study.

Gross pathology:

No gross lesions were seen at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of the substance was higher than 5000 mg/kg: the substance should not be classified for oral toxicity.