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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(+)-tartaric acid
EC Number:
201-766-0
EC Name:
(+)-tartaric acid
Cas Number:
87-69-4
Molecular formula:
C4H6O6
IUPAC Name:
(2R,3R)-2,3-dihydroxybutanedioic acid
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 or test system 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.