Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, comparable to Guideline study, pre-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
single treatment via gavage
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-nitro-o-anisidine
EC Number:
202-588-6
EC Name:
4-nitro-o-anisidine
Cas Number:
97-52-9
Molecular formula:
C7H8N2O3
IUPAC Name:
2-methoxy-4-nitroaniline
Constituent 2
Reference substance name:
PNOA
IUPAC Name:
PNOA

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann BOR: WISW (SPF Cpb)
- Age at study initiation: ca. 14 W

- Fasting period before study: 16 h
- Housing: Macrolon Type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 1,5 C
- Humidity (%): 60 +/- 5%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Appl. Volume: 20 ml/kg bw
Doses:
100-1000-1500-2000-3100-5000 mg/kg in males
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
Observations:
Clin. signs
Mortality
Body weighht
Necropsy (random sample)
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Mortality:
Dose (mg/kg) Moratlity (2-10 d after treatment)
100 0/10
1000 1/10
1500 1/10
2000 5/10
3100 9/10
5000 10/10
Clinical signs:
other: reduced general condition, Sedation, ruffled fur, narcosis, Chromodakryorhea
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
4-Nitro-2-methoxyaniline was practically non toxic in male rats. The LD50 was 2000 mg/kg bw.