TCA

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August-October 1973.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study. No GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

The study of Acute Subcutaneous Toxicity of the product sodium trichloroacetate has been performed on male Sprague-Dawley rats. Nine doses were tested (126, 252, 504, 1000, 2000, 2520, 3180, 4000 and 5040 mg/kg bw). For each dose level, a group of ten rats was exposed to this substance through subcutaneous route. During a 14-day observation period, animals were daily controlled in what concerns cases of death, time of death, general behavior and food- and water-consumption. Body weight was recorded at days 0, 7 and 14. At the end of the study all animals were sacrificed and macroscopically examined.

GLP compliance:

no

Limit test:

no

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): NaTA

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Auszuchtstamm der Tierzüchterei S.IVANOVAS, 7964 Kililegg/Allgäu, PO Box 7
- Age at study initiation: ca. 38 days old
- Weight at study initiation: 100-105 g
- Fasting period before study: 16 hours (until 2 hours post-injection)
- Housing: Animals were housedc individually in Makrolon cages (type II).
- Diet (e.g. ad libitum): Altromin 1323 (from Altromin GmbH, 4937 Lage/Lippe, PO Box 285); ad libitum.
- Water (e.g. ad libitum): Tap water; ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 0.5 ºC
- Humidity (%): 60 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hours light (250 Lux)/ 12 hours dark

IN-LIFE DATES: August-October 1973.

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

other: aqueous carboxyethyl cellulose gel

Details on exposure:

Constant volume injected: 5 mL/kg
Vehicle concentration: 1%

Doses:

126, 252, 504, 1000, 2000, 2520, 3180, 4000 and 5040 mg/kg bw.

No. of animals per sex per dose:

10 male rats per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During this period, mortalities, general behavior and food and water consumption were daily observed. The body weight was recorded with an interval of 7 days.
- Necropsy of survivors performed: yes

Statistics:

The LD50 was calculated according to Litchfield and Wilcoxon. It was calculated for 7 days.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

95% CL:

3 670 - 4 350

Mortality:

Lowest lethal dose: 4000 mg/kg.
Death occurred within 2-24 hours after several hours of coma.
The surviving animals recovered within 4 days.

Clinical signs:

Lowest toxic dose: between 126 and 252 mg/kg.
Sedation, ataxia, less food consumption (252 mg/kg), prone or side position, less reflexes, reduced body weight (2000 mg/kg); extremities paralysis and coma (4000 mg/kg).
From 3180 mg/kg: local edema, which healed within 5-10 days.

Body weight:

Reduced body weight: from 2000 mg/kg

Gross pathology:

Dead animals during the study: pale parenchimas.
Surviving animals: no anamoticopathological alterations were found in any organ during the autopsies.

Any other information on results incl. tables

Dose (mg/kg bw)	Mortality rate (dead animals/exposed animals)
126	0/10
252	0/10
504	0/10
1000	0/10
2000	0/10
2520	0/10
3180	0/10
4000	5/10
5040	10/10

Table 07.02.04_01. Mortality rate after a single subcutaneous administration of sodium trichloroacetate.

Applicant's summary and conclusion

Conclusions:

The subcutaneous LC 50 of sodium trichloroacetate was 4000 mg/kg bw (95% CL: 3670-4350 mg/kg bw) for rats.

Executive summary:

The study of Acute Subcutaneous Toxicity of sodium trichloroacetate has been performed on male Sprague-Dawley rats. Nine doses were tested (126, 252, 504, 1000, 2000, 2520, 3180, 4000 and 5040 mg/kg bw). For each dose level, a group of ten rats was exposed to this substance through subcutaneous route. During a 14-day observation period, animals were daily controlled in what concerns cases of death, time of death, general behavior and food- and water-consumption. Body weight was recorded at days 0, 7 and 14. At the end of the study all animals were sacrificed and macroscopically examined. The subcutaneous LC 50 of sodium trichloroacetate was 4000 mg/kg bw (95% CL: 3670-4350 mg/kg bw) for rats.