3-chloroaniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline stdy

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 84/449/EWG

Principles of method if other than guideline:

Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

3-chloroaniline

EC Number:

203-581-0

EC Name:

3-chloroaniline

Cas Number:

108-42-9

Molecular formula:

C6H6ClN

IUPAC Name:

3-chloroaniline

Test material form:

other: liquid

Details on test material:

CAS no.: 108-42-9
purity: 99.5%
molecular weight. 127.6 g/mol
appearance: weak yellow liquid
density: 1.21 g/m³

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Doses:

100, 250, 312, 400, 500 or 1000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female animals/dose

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 353 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 400 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

At a dose of 100 mg/kg bw a bad general condition, ruffle fur, discharge of the nose, sedation, bloody shout and salivation was observed. Beginning with 250 mg/kg bw most of the animals revealed cyanosis and some animals showed gasping. At a dose of 1000 mg/kg bw 2 females had a lateral position 2 hours after application of the test substance and one female showed convulsions.

Pathological signs of the deceased animals at doses of 400 to 1000 mg/kg bw were changes of the gastrointestinal tract, brownish discoloured and edematuos lungs and at 500 mg/kg bw black discoulered livers. All animals sacrificed at the end of the study revealed no pathological signs.

The LD50 for male rats was ca. 400 mg/kg bw and the approximative LD50 for females was 353 mg/kg bw.

Applicant's summary and conclusion

Executive summary:

Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.

The LD50 was approx. 353 mg/kg bw for female and 400 mg/kg bw for male rats.