Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
0
Reversibility:
other: No effect
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.