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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 01.03.2004 to 08.03.2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD guideline 404, 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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

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): Tricloroacetato de sodio
- Analytical purity: 99 % (w/w)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult animals
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ºC
- Humidity (%): 60 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 01.03.2004 to 08.03.2004

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The right side of each treated animal was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water
- Time after start of exposure: 4 hours

SCORING SYSTEM: The degree of irritation was daily registered for three days to be later scored in order to make a whole assessment of the effects.
The score was performed within 30-60 minutes, at 24, 48 and 72 hours.
- Erythema and eschar formation:
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema to slight eschar formation 4
Maximum possible 4
- Edema formation:
No edema 0
Very slight edema 1
Slight edema 2
Moderate edema 3
Severe edema 4
Maximum possible 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 -72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 -72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium trichloroacetate has shown potential of slight irritation for the rabbits skin, and the effects were fully reversible within 7 days.
Executive summary:

This study has been carried out with the aim of evaluating the possible irritant / corrosive effects of sodium trichloroacetate on the skin, using white rabbits (Oryctolagus cuniculus). The method of the assay has been developed according to OECD Protocol Nº 404,1992. A single dose of 0.5 gwas applied to a skin area of approximately 6 cm2 in three rabbits (males). During the assay period, environmental conditions remained constant (Temperature:22°C, Humidity: 60 % and Photoperiod: twelve hours light and twelve hours darkness). The degree of irritation was daily registered for three days to be later scored in order to make a whole assessment of the effects. Sodium trichloroacetate has shown potential of slight irritation for the rabbits skin, and the effects were fully reversible within 7 days.