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Toxicological information

Acute Toxicity: dermal

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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

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/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.