2,4,5-trichloroaniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles. Study was conducted prior to GLP implementation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

test was performed up to 5000mg/kg bw; incomplete necropsy

GLP compliance:

no

Remarks:

Study performed prior to GLP regulations

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4,5-trichloroaniline

EC Number:

211-254-9

EC Name:

2,4,5-trichloroaniline

Cas Number:

636-30-6

Molecular formula:

C6H4Cl3N

IUPAC Name:

2,4,5-trichloroaniline

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen Germany
- Age at study initiation: about 9 to 14 weeks
- Weight at study initiation: male mean body weight of about 177 g, female mean body weight of about 166 g
- Fasting period before study: 16 hours
- Housing: Makrolon cages in groups of five animals
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5°C
- Humidity (%): 60 ± 5%
- Photoperiod (hrs dark / hrs light):v 12/12

IN-LIFE DATES: From: 1981-05-27 To: 1981-07-07

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

Males: 3100 and 5000 mg/kg bw
Females:1000, 3100 and 5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On day of application animals were observed several times, thereafter two times a day. The weight was determined at day of application, survivors after one week and at the end of the 14 day observation period.
- Necropsy of survivors performed: yes random examination
-No other examinations were performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

See Table below

Clinical signs:

other: narcosis, scrubby fur, prone position, slight lost of body weight, paralysis of the hind limbs, ensanguined eyes, reduced general condition

Gross pathology:

Macroscopically no findings

Other findings:

none

Any other information on results incl. tables

Tab.   Acute oral toxicity of 2,4,5-Trichloranilin after a single

oral application to rats

Dose [mg/kg bw]	Mortality	Time of death^1	Start of symptoms^1
Males
3100	0/10	—	—
5000	2/10	Day 4	2 h
Females
1000	0/10	—	—
3100	4/10	24 hours, Day 4	4 h
5000	4/10	Day 3- 4	2h

¹hours or days after application

Based on the results of this study the acute oral toxicity (LD50) of 2,4,5 -Trichloranilin was determined to be greater than 5000 mg/kg bw for male and female rats.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the results of this study the acute oral toxicity (LD50) of 2,4,5 -Trichloranilin was determined to be greater than 5000 mg/kg bw for male and female rats. Based on this result no classification is required.