Calcium tartrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test was performed in an EN-ISO 17025 accredited laboratory for the purpose of waste characterisation under Spanish Ministerial Order 13/10/1989 and Royal Decree 952/97. Although the test was not performed by a GLP accredited laboratory the official EU / OECDE test method was followed and all reporting a quality criteria in the test guideline were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Potassium sodium tartrate

EC Number:

206-156-8

EC Name:

Potassium sodium tartrate

Cas Number:

304-59-6

Molecular formula:

C4H6O6.K.Na

IUPAC Name:

potassium sodium tartrate

Details on test material:

Substance referred to as Potassium Sodium Tartrate Tetrahydrate resulting from an accidental spill during loading. Purity of tested sample prior to becoming waste: >98%. No apparent soiling of foreign materials appreciable in sample received at test laboratory. Sample received referenced labelled "Sal de Rochelle polvo 280410"

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories (France)
- Weight at study initiation: > 1750
- Housing: Individual stainless steel cages, suitably identified.
- Diet: ad libutum. Granulated maintenance feed. Supplier: Harlan Iberica. S.L.
- Water : ad libitum (water from municipal supply city of Madrid)
- Acclimation period: 20 days. No anomalies observed after end of acclimation.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

moistened slightly with water for improved contact

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g of test substance per animal (in semiocclusive patch)

Duration of treatment / exposure:

4 hours

Observation period:

3 days, no effect was observed, thereby additional observation was not required.

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: Dorsal region , > 6 cm2
- Type of wrap if used: self-adhesive, hypoallergenic, semi-occlusive patch (Mepore (R) or similar). Held with cotton bandage and elastic tubular mesh bandage..

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle rinsing with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to tables in EU test Guidelione B.4.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72

Score:

0

Max. score:

0

Reversibility:

other: No effect

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72

Score:

0

Max. score:

0

Reversibility:

other: No effect

Irritant / corrosive response data:

Erythema and edema score was 0 at 24, 48 and 72 h in the two animals tested. No effects observed upon the skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance Potassium Sodium Tartrate, tested in two White New Zealand rabbits, applied slightly moistened upon the shaved skin, according to EU test guideline B.4 yielded no irritant response whatsoever, scoring 0 in terms of edema and erythema at all observation periods (24, 48, 72 h). The test substance is concluded to be non-irritating to the skin according to the definitions and procedures of the test guideline.

Executive summary:

The test substance Potassium Sodium Tartrate, tested in two White New Zealand rabbits, applied slightly moistened upon the shaved skin, according to EU test guideline B.4 yielded no irritant response whatsoever, scoring 0 in terms of edema and erythema at all observation periods (24, 48, 72 h). The test substance is concluded to be non-irritating to the skin according to the definitions and procedures of the test guideline.