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Toxicological information

Acute Toxicity: other routes

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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

Constituent 1
Chemical structure
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.