3-nitro-p-anisic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed study but only poor documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: company SOP

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-nitro-p-anisic acid

EC Number:

201-906-0

EC Name:

3-nitro-p-anisic acid

Cas Number:

89-41-8

Molecular formula:

C8H7NO5

IUPAC Name:

4-methoxy-3-nitrobenzoic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Wistar TNO W 74
- Source: Winkelmann, Borchen
- Age at study initiation: approximatrely 14 weeks
- Weight at study initiation: average 169 g
- Housing: inmakrolon cages typ III with wood granulate in groups of 5 animals
- Diet: Altromin R 1324 (Altromin GmbH, Lage), . ad libitum
- Water : tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1.5 °C
- Humidity (%): 60 +- 5
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: lutrol

Doses:

5000 mg/ kg bw
administered with a constant application volume of 20 ml /kg bw suspendsed in lutrol

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (twice daily , once on weekends) and weighing (day 1 and 14)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs,

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: Sedation, coat sparse, general condition decreased, decrease of body at one animal

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance id greater than 5000 mg/kg bw.

Executive summary:

The substance was tested for acute oral toxicity. 10 female Wistar rats received once a dose of 5000 mg/kg bw. No mortality occured but syptoms such as sedation, coat sparse and decreased general condition were observed. The development of the body weight was normal except at one animal.