2-nitroaniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study report, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Standard acute method before coming into effect of the OECD testing guideline.
The test substance was administered to 10 female SPF-Wistar rats/dose group at doses of 800, 1250, 1600, 2000, and 3200 mg/kg bw by gavage in a starch emulsion. The animals were observed during the 14-days post-observation time for lethality, and clinical signs of intoxictation.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-nitroaniline

EC Number:

201-855-4

EC Name:

2-nitroaniline

Cas Number:

88-74-4

Molecular formula:

C6H6N2O2

IUPAC Name:

2-nitroaniline

Details on test material:

- Name of test material (as cited in study report): Echtorange GR Base = 2-nitro-1-aminobenzol
- Analytical purity: 98.5-99.5% base

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: SPF-Wistar
- Source: Hoechst AG breed
- Weight at study initiation: 80 - 110 g (mean: 94 g)
- Fasting period before study: yes, 16 hours
- Diet (ad libitum): Altromin 1324 (Altrogge, Lage/Lippe, Germany)
- Water (ad libitum): tap water

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: starch emulsion 10 %

Doses:

800, 1250, 1600, 2000, and 3200 mg/kg bw

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 and weighing: before test start, after 7 and 14 days
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 was determined by means of probit analysis according to the method by Lindner and Weber. Confidence limits were calculated following Cavalli-Sporza

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

1 838 mg/kg bw

Based on:

test mat.

95% CL:

1 673 - 2 018

Mortality:

At the two lowest doses, all animals survived until study termination. At 1600 and 2000 mg/kg bw 2/10 and 7/10 animals died, respectively. At the highest dose all animals died within 24 hours after administration.

Clinical signs:

other: Tremors, convulsions, narcotic-like state, yellow urine.

Gross pathology:

No abnormalities in the deceased animals.

Any other information on results incl. tables

Dose [mg/kg bw]	Concentration [%]	Dead animals/animals tested
800	10	0/10
1250	10	0/10
1600	10	2/10
2000	10	7/10
3200	10	10/10

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU