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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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tartaric acid
- Substance type: white powder
- Analytical purity: 99.5%
- Lot/batch No.: B 10X 1914

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bettinardi Breeding-Momo-(NO)
- Weight at study initiation: 3370-3410 g
- Housing: Each rabbit has been caged in NORYL cages (dimensions cm 48.2X63X37 h, area cm2 3040).
- Diet (e.g. ad libitum): animals were fed with a standard pellet complete diet supplied by the authorised breeder.
- Water (e.g. ad libitum): animals have been watered with purified water from automatic ad libitum watering systerm.
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hour after the application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: square gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using a pad soaked with physiological solution.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
see the table in the any other information on materials and methods incl. tables

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
not reversible
Irritant / corrosive response data:
see table 1

Any other information on results incl. tables

Table. 1

Skin reaction

Time after bandage

Rabbit number

Average

516

517

518

Erythema

60 minutes

0

0

0

0.00

24 hours

0

0

0

0.00

48 hours

0

0

0

0.00

72 hours

0

0

0

0.00

Oedema

60 minutes

0

0

0

0.00

24 hours

0

0

0

0.00

48 hours

0

0

0

0.00

72 hours

0

0

0

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the results, interpreted according to Official Journal of the European Union 1272/2008 (CLP) dated December 16th 2008 and OECD number 404 April 24th 2002, the test substance ‘tartaric acid’ must be considered not irritant for the skin.
Executive summary:

An acute dermal irritation test was performed on the test substance “tartaric acid” in order to obtain the necessary data to evaluate its toxic effects. 0.5 g of the test substance was applied in a single dose on about 6 cm2 intact skin of 3 rabbits for four hours with a semi-occlusive application with a no irritant gauze. After the removal of the gauzes and in the following 1, 24, 48 and 72 hours, the animals have been surveyed possible erythema and/or edema events. In all treated and control sites no edema or erythema was observed.