TCA

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-October 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method similar to OECD guideline 402, but no GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

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/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Auszuchtstamm the Tierzüchterei S. Ivanova, 7964 Kißlegg / Allgäu, PO Box 7
- Weight at study initiation: 100-105 g
- Housing: Animals were housed individually in Makrolon cages (type III).
- Diet (e.g. ad libitum): Altromin 1323 (From Altromin GmbH, Lage/Lippe). Ad libitum, except for the application day.
- Water (e.g. ad libitum): Ad libitum, except for the application day.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 ºC
- Humidity (%): 60 ± 3 %
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: August-October 1973

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: aqueous methyl-hydroxiethyl cellulose gel MH 300 P

Details on dermal exposure:

TEST SITE
- Area of exposure: Intact dorsal skin.
- % coverage: 4.5 x 5 cm, 1/10 of body surface
- Type of wrap if used: 4-fold gauze, covered with aluminum foil and with an elastic plaster bandage (Elastoplast, 8 cm, BEIERSDORF AG, 2000 Hamburg 20) around the body.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With warm water (30 ºC)
- Time after start of exposure: 24 hours

VEHICLE
- Amount(s) applied (volume or weight with unit): 5g/kg bw
- Concentration: 1%

Duration of exposure:

24 hours. During the exposure period, the animals were kept individually in glass tubes.

Doses:

250, 500, 1000 and 2000 mg/kg

No. of animals per sex per dose:

3 male and 3 female rats per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Skin reaction, general behavior and feed consumption were daily checked. Body weight were recorded at days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

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 LD 50 of sodium trichloroacetate was greater than 2000 mg/kg bw for rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC 50 of sodium trichloroacetate was greater than 2000 mg/kg bw for rats.

Executive summary:

The study of Acute Dermal Toxicity of sodium trichloroacetate has been performed on male and female Sprague-Dawley rats. Four doses were tested (250, 500, 1000 and 2000 mg/kg bw) during 24 hours. For each dose level, a group of six rats (three males and three females), was exposed to this substance through dermal route. During a 14-day observation period, animals were daily controlled in what concerns cases of death, time of death, general behavior and food-consumption. Body weight was recorded at days 0, 7 and 14. At the end of the study all animals were sacrificed and macroscopically examined. According to the results obtained, the LD50 of sodium trichloroacetate was greater than 2000 mg/kg bw.