TCA

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16.02.2004 to 01.03.2004.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method according to OECD guideline 401, but no data on GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

TCA

EC Number:

211-479-2

EC Name:

TCA

Cas Number:

650-51-1

Molecular formula:

C2HCl3O2.Na

IUPAC Name:

trichloroacetic acid

Details on test material:

- Name of test material (as cited in study report): Tricloroacetato de sodio
- Analytical purity: 99 % (w/w)

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: 8 to 12 weeks old
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ºC
- Humidity (%): 60 %
- Photoperiod (hrs dark / hrs light): twelve hours light and twelve hours darkness


IN-LIFE DATES: From: 16.02.2004 To: 01.03.2004

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female per group

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were controlled in what concerns cases of death, time of death, body weight, clinical and anatomicopathological alterations.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed in any group of animals.

Clinical signs:

other: There were no changes in animal behavior.

Gross pathology:

No anatomicopathological alterations were found in any organ during the autopsies.

Any other information on results incl. tables

The oral LD 50 was greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD 50 was greater than 2000 mg/kg bw.

Executive summary:

The study of Acute Oral Toxicity of sodium trichloroacetate has been performed using white rats (Rattus norvergicus), Wistar strain. The assay method has been developed according to the OECD Protocol No. 401, 1987. For that purpose, the limit concentration (2.000 mg/kg) was assayed by administering it through oral route to a group of ten rats (five females and five males). Another group of equal number was used as control group without treatment. During the assay period, environmental conditions were kept constant (Temperature: 22 °C, Humidity: 60 % and Photoperiod: twelve hours light and twelve hours darkness). During a fourteen-day observation period, animals were controlled in what concerns cases of death, time of death, body weight, clinical and anatomicopathological alterations. According to the results obtained, the oral LD50 was greater than 2000 mg/kg bw.