4-chloroaniline

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: Basic data given

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Evaluation de la toxicite d´agents d´activite´cosmetique cas du trichlorocarbanilide

Author:

Marty JP, and Wepierre J

Year:

1979

Bibliographic source:

Labo Pharma Problemes et techniques, 286, April 1979

Reference 2

Reference Type:

review article or handbook

Title:

BUA-Stoffbericht No 153: p-chloraniline

Author:

BUA (Beratergremium umweltrelevanter Altstoffe) (BUA)

Year:

1995

Bibliographic source:

Gesellschaft Deutscher Chemiker (Hrsg Behret) VCH (Verlag Chemie), Weinheim

Materials and methods

Principles of method if other than guideline:

The LD50 of p-chloroaniline was determined through oral administration (gavage)

GLP compliance:

no

Remarks:

GLP was not mandatory at the time of the study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-chloroaniline

EC Number:

203-401-0

EC Name:

4-chloroaniline

Cas Number:

106-47-8

Molecular formula:

C6H6ClN

IUPAC Name:

4-chloroaniline

Details on test material:

- Name of test material (as cited in study report): p-chloroaniline
- Analytical purity: no data
- Radiochemical purity (if radiolabelling): between 98 and 99%
- Specific activity (if radiolabelling): 19.7 mCi/mmol
- Locations of the label (if radiolabelling): parachloroaniline-14C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cesal , France
- Weight at study initiation: 170 g
- Fasting period before study: no



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 1 °C
- Humidity (%): 50 ± 10%
- Air changes (per hr): 10 times per hour

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

not reported

No. of animals per sex per dose:

Not reported

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

LD50 was calculated according to the method of Litchfield and Wilcoxon, J. Pharmacol. Exp. Ther 96, 99, 1945

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

340 mg/kg bw

95% CL:

280 - 414

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

300 mg/kg bw

95% CL:

246 - 366

Clinical signs:

other: response to the touch, restlessness, tremors and respiratory difficulties, cyanosis and a more advanced stage of intoxication

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Like other chloroanilines, the primary toxic effect of 4-chloroaniline is methaemoglobin formation. Taking into account that humans are much more sensitive to methaemoglobin producing substances than rats and that sufficient results of studies with cats, better suited to judge the level of toxicity for humans, are not available, 4-chloroaniline is classified as Toxicity Category III.

Executive summary:

Marty (1979):

The LD50 of p-chloroaniline was determined through oral administration (gavage).

LD 50 was estimated to be 340 mg/kg bw (280-414) and 300 mg/kg bw (246-366) according to the method of Lichfield and Wilcoxon.

Response to the touch, restlessness, tremors and respiratory difficulties, cyanosis and a more advanced stage of intoxication.