Registration Dossier
Registration Dossier
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EC number: 212-773-3 | CAS number: 868-18-8
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 / OECD 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
- Remarks:
- The test was performed in an EN-ISO 17025 accredited laboratory (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/OECD test method was followed.
Test material
- Reference substance name:
- potassium sodium tartrate tetrahydrate
- EC Number:
- 613-385-0
- Cas Number:
- 6381-59-5
- Molecular formula:
- C4H12KNaO10
- IUPAC Name:
- potassium sodium tartrate tetrahydrate
- 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 tartarate
Constituent 1
Constituent 2
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 g
- Housing: Individual stainless steel cages
- 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 ± 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 Guideline B.4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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.
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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