TCA

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25.02.2004 to 10.03.2004.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method according to OECD guideline 403, 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 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

(no data is provided on the actual concentration of the test substance)

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: 8-12 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 %
- Air changes (per hr): 10 volumes/h
- Photoperiod (hrs dark / hrs light): twelve hours light, twelve hours darkness

IN-LIFE DATES: From 25.02.2004 to 10.03.2004

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

nose only

Vehicle:

other: water

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The inhalation chamber was made of transparent, hard acrylic and resistant to strong acid and alkaline substances.
- Exposure chamber volume: 4800 cm3
- Method of holding animals in test chamber: Traps
- Source and rate of air: 4 L/minute

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

20 mg/L air

No. of animals per sex per dose:

5 male and 5 female rats 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:

LC50

Effect level:

> 20 mg/L air (nominal)

Exp. duration:

4 h

Mortality:

No mortalities were observed in any group of animals.

Clinical signs:

other: There were no changes in animal behavior.

Body weight:

There were no changes in body weight between the groups.

Gross pathology:

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

Any other information on results incl. tables

LC 50 was greater than 20 mg/L for rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LC 50 was greater than 20 mg/L for rats.

Executive summary:

The study of Acute Inhalation Toxicity of sodium trichloroacetate has been performed using Wistar white rats (Rattus norvergicus). The assay method has been developed according to the OECD Protocol No.403, 1981. For that purpose, the limit concentration (Limit test) of 20 mg/L air was assayed during four hours. For the dose level above described, a group of ten rats (five females and five males), was exposed to this substance through inhalation route and another group of equal number was used as control group without treatment. The flow of air was 4 L/minute and its turnover of 10 volumes/ hour. During the assay period, environmental conditions (Temperature: 22°C, Humidity: 60 % and Photoperiod: twelve hours light, twelve hours darkness) were kept constant.

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 four-hour inhalation LC 50 of sodium trichloroacetate was greater than 20 mg/L.