2,4-dichloroaniline

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: Guideline study under GLP condition

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dichloroaniline

EC Number:

209-057-8

EC Name:

2,4-dichloroaniline

Cas Number:

554-00-7

Molecular formula:

C6H5Cl2N

IUPAC Name:

2,4-dichloroaniline

Test material form:

other: brown-red flakes

Details on test material:

- Name of test material (as cited in study report): 2,4-dichloroaniline
- Physical state: solid
- Analytical purity: 99%
- Impurities (identity and concentrations): 2,6-dichloroanilin; monochloranilin (p-chloranilin)
- Lot/batch No.: GAEC 43
- Storage condition of test material: at the dark at 22 °C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 weeks (males); females: 8 weeks
- Weight at study initiation:
males: ca 181.1 g; females: ca.175.1 g
- Fasting period before study: 16 h;
- Fasting after test substance administration: 4 h
- Housing: in groups of 5
- Diet e.g. ad libitum
- Water e.g. ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aequous potato starch

Details on oral exposure:

single oral application by gavage as 2 % aequous potato starch

Doses:

2000, 2500, 3150, and 4000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

other: not applicable

Details on study design:

Groups of 5 males and 5 females received different doses as single oral application by gavage as 2 % aequous potato starch and observed for 14 days mortality and symtoms were recorded; Body weight determination once before treatment, once during observation period and once at termination of the study. Necropsy and gross pathological examination of all animals

Statistics:

The LD 50, the 95% confidence level and the equation of Probit linear slope were calculated from the encountered rate of lethality using the Probit analysis.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 110 mg/kg bw

95% CL:

2 620 - 3 870

Remarks on result:

other: cyanosis (up to 4 days post application), irregular respiration, blood-coloured secretions of noses and eyes, clonic convulsions and miosis, nonspecific symptoms: effects on the musculoskeletal system. All symptoms disappeared within 6 days.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 830 mg/kg bw

95% CL:

>= 1 860 - <= 3 940

Remarks on result:

other: calculated from mrtality data

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 3 330 mg/kg bw

95% CL:

>= 2 590 - <= 5 180

Remarks on result:

other: calculated from mortality data

Mortality:

Lethality occurred until 3 days after application:
males and females:
2000 mg/kg bw: 0/5 and 1/5
2500 mg/kg bw: 1/5 and 2/5
3150 mg/kg bw: 3/5 and 2/5
4000 mg/kg bw: 3/5 and 5/5

Clinical signs:

other: The poisoning was characterized by nonspecific symptoms: effects on the musculoskeletal system and respiration , cyanosis (up to 4 days post application), blood-coloured secretions of noses and eyes, clonic convulsions and miosis. All symptoms were reve

Gross pathology:

death males and females:
The macroscopic findings showed discoloration of dead animals´ adrenal glands, bleeding in the small intestine, congestion of the lungs and bulging bladders.
surviving annimals:
The section of the surviving animals showed no macroscopically visible changes

Applicant's summary and conclusion

Executive summary:

2,4 -dichloroaniline was tested for acute oral toxicity according to OECD TG 401 under GLP conditions. Groups of male and female Wistar rats received 2000 -4000 mg/kg bw as single application suspended in aequous potato starch and were observed for 14 days for mortality, clinical symptoms and body weight development. After termination of the observation period surving animals were sacrificed and all animals were examined macroscopically.

.Animals showed cyanosis (up to 4 days post application), irregular respiration, blood-coloured secretions of noses and eyes, clonic convulsions and miosis, and nonspecific symptoms of the musculoskeletal system. All symptoms disappeared within 6 days. Body weight development was not affected by treatment. Death occurred within 3 days after application resulting in a LD50 value of 3110 mg/kg bw for male and female rats.