Registration Dossier
Registration Dossier
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EC number: 202-588-6 | CAS number: 97-52-9
Acute Toxicity: oral
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:
- 1 982
- 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
- 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
- Reference substance name:
- PNOA
- IUPAC Name:
- PNOA
Constituent 1
Constituent 2
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.
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