4-chloroaniline

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxicology and carcinogenesis studies of p-chloroaniline hydrochloride (CAS no. 20265-96-7) in F344/N rats and B6C3F1 mice (gavage studies)

Author:

NTP

Year:

1989

Bibliographic source:

U.S. department of health and human services Public Health Service National Institutes of Health National toxicology program Technical Report Series No. 351

Reference 2

Reference Type:

review article or handbook

Title:

4-CHLOROANILINE

Author:

IPCS-INCHEM

Year:

2003

Bibliographic source:

in: Concise International Chemical Assessment Document 48

Materials and methods

Principles of method if other than guideline:

Groups of five rats of each sex were administered 25, 50, 100, 200, or 400 mg/kg p-chloroaniline by gavage in aqueous hydrochloric acid, 5 days per week for a total of 12 doses over 16 days. Vehicle controls received deionized water by gavage. A necropsy was performed on all animals.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-chloroanilinium chloride

EC Number:

243-656-5

EC Name:

4-chloroanilinium chloride

Cas Number:

20265-96-7

IUPAC Name:

4-chloroanilinium chloride

Constituent 2

Reference substance name:

p-chloroaniline hydrochloride

IUPAC Name:

p-chloroaniline hydrochloride

Details on test material:

- Name of test material (as cited in study report): p-chloroaniline hydrochloride
- Physical state: solid
- Analytical purity: p-Chloroaniline (99% pure) was used to prepare p-chloroaniline hydrochloride solutions for administration to animals.
- Lot/batch No.: 127
- Stability under test conditions: the chemical was found to be stable in water for at least 14 days at room temperature
- Storage condition of test material: room temperature
- Other: the chemical was found to be stable in water for at least 14 days at room temperature dose mixtures were prepared at weekly intervals, placed in foil wrapped containers, and refrigerated until the day of dosing.

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionized water

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

16 days

Frequency of treatment:

5 days per week

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 50, 100, 200, or 400 mg/kg of body weight.
Basis:
actual ingested

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Examinations

Sacrifice and pathology:

Necropsy performed on all animals; histologic exams performed on 2 males and 2 females in the vehicle control and 100 mg/kg groups. Tissues examined include: adrenal glands, bone marrow, brain, colon, esophagus, heart, jejunum, kidneys, liver, lungs and mainstem bronchi, mandibular lymph nodes, pancreas, parathyroid glands, pituitary gland, prostate/ testes or ovaries/uterus, regional lymph nodes, salivary glands, skin, spleen, stomach, thymus, thyroid gland, tissue masses, trachea, and urinary bladder. Spleen examined from 2 males and 2 females in the 25 mg/kg groups.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

In the 16-day studies, male and female rats received 25, 50, 100,200, or 400 mg/kg of body weight. The vehicle controls received deionized water.

All rats that received 200 or 400 mg/kg died during the first 6 days of the studies. Splenic enlargement was observed at necropsy in rats administered 25, 50, or 100 mg/kg. Congestion of the spleen and hemosiderin deposition in the renal cortical tubular epithelial cells were observed at 100 mg/kg in male and female rats