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Toxicological information

Skin irritation / corrosion

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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.

 

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