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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

Constituent 1
Chemical structure
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:
No clinical signs were noted during the study.
Body weight:
Body weight of both sexes remained within the normal range.
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.