Registration Dossier
Registration Dossier
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EC number: 211-479-2 | CAS number: 650-51-1
Skin irritation / corrosion
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:
- 2 004
- 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
- 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)
Constituent 1
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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