(+)-tartaric acid

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

ca. 0

Max. score:

0

Reversibility:

not reversible

Results 2

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.