2-nitroaniline

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study conducted in compliance with GLP regulations. Original report not available. Data, reliability and rationale adopted according to OECD SIDS (2003) (publicly available peer reviewed source). Study according to OECD 422 (all organs, but not hematology or biochemistry; no indication of MetHb in preliminary study).

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2001

Reference 2

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for SIAM 13 (o-nitroaniline) November 6-9, 2001 Bern, Final July 2003.

Author:

OECD SIDS

Year:

2003

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Principles of method if other than guideline:

As part of a reprotoxicity study, the number of animals was 12 per sex at the beginning and 10 animals per sex were used to continue the reprotoxicity part of the study and the examinations.

GLP compliance:

yes

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Males: from 4 weeks prior to mating, during mating, gestation of the females: i.e: 9 weeks.
Females: from 4 weeks prior to mating, during mating, gestation and lactation periods until post-partum day 3. Approximately 9 weeks.

Frequency of treatment:

Daily (7 days a week)

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 50, 150, 450 mg/kg bw/day
Basis:
actual ingested

No. of animals per sex per dose:

12

Control animals:

yes, concurrent vehicle

Results and discussion

Results of examinations

Details on results:

CLINICAL SIGNS AND MORTALITY
The only signs related to treatment were piloerection, salivation and matted fur observed after treatment. Matted fur was also observed and clinical
signs performed at weekly intervals in males and females of the high-dose group. No cyanosis was seen as an indication of methemoglobinemia.

BODY WEIGHT AND WEIGHT GAIN
Statistically significant reduction in body weight (5-6%) were observed at different times in high and mid dose groups during the treatment.
A statistically significant reduction in terminal bodyweight was observed in high-dose males (6%) compared to controls.

ORGAN WEIGHTS
No differences were observed in absolute and relative organ weights of males.

GROSS PATHOLOGY/HISTOPATHOLOGY: NON-NEOPLASTIC
Macroscopic and microscopic observations of all organs, including spermatogenic cycle, did not reveal any treatment-related effects.

Effect levels

1

Dose descriptor:

NOEL

Effect level:

50 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

2

Dose descriptor:

LOAEL

Effect level:

150 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: body weight

Target system / organ toxicity

Critical effects observed:

not specified