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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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: well performed GLP and OECD gudeline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methoxy-3-nitro-N-phenylbenzamide
EC Number:
202-572-9
EC Name:
4-methoxy-3-nitro-N-phenylbenzamide
Cas Number:
97-32-5
Molecular formula:
C14H12N2O4
IUPAC Name:
4-methoxy-3-nitro-N-phenylbenzamide

Test animals

Species:
rat
Strain:
other: Wistar, Hoe: WISKf(SPF71)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG company breeding colony
- Age at study initiation: male ca. 7 weeks, female ca. 8 weeks
- Weight at study initiation: male mean 171 g, female mean 179 g
- Fasting period before study: ca. 16 h
- Housing: AC, plastic cages with softwood granules, 5 animals per cage
- Diet (e.g. ad libitum): Rattendiät Altromin 1324, ad libitum
- Water (e.g. ad libitum): botteled tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% starch mucilage
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 10 ml/kg bw.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.

Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily, once daily at weekend and holiday
- Frequency of weighing: once a week
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw. male: 0 of 5
2000 mg/kg bw. female: 0 of 5
Clinical signs:
other: IRREGULAR RESPIRATION, FLANKS DRAWN IN, STILTED GAlT, UNCOORDINATED GAlT, SQUATTING POSTURE. NO ABNORMALITIES DETECTED at day 3 and thereafter.
Gross pathology:
no abnormal finding
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50: >2000 mg/kg bw.

Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008.
Executive summary:

Male and female Wistar-rats were subjected to test acute oral toxicity according to OECD guideline 401. The test substance was administered by gavage at a dose of 2000 mg/kg bw (20% suspension in 2% starch mucilage). No animal died during the 14 day observation period, resulting in a LD50 >2000 mg/kg bw.