Registration Dossier
Registration Dossier
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EC number: 931-219-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide
- EC Number:
- 931-219-8
- Molecular formula:
- SinO(3n-1)2(n-1) polymeric anions ionically bonded to Al3+ and K2+ cations
- IUPAC Name:
- silicon(4+) dialuminium(3+) dipotassium hexaoxidandiide
- Test material form:
- solid: fibres
- Details on test material:
- - Name of test material (as cited in study report): Superwool 1400
- Substance type: Chopped fibrous wool
- Physical state: solid
- Analytical purity: >99%
- Stability under test conditions: stable
- Storage condition of test material: dry sealed container
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Biceseter
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum, Global Diet 2930C
- Water (e.g. ad libitum): ad libitum, mains drinking water
- Acclimation period: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 52 - 57
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hour cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g/rabbit - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank area
- % coverage:
- Type of wrap if used: 2.5cm square gauze patch, secured using elastic compression tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24hrs
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation or corrosive effects seen
Any other information on results incl. tables
Table1Individual dermal reactions
Dermal reaction |
Observation Time |
Individual Scores – Rabbit Number, Sex, Initial Body weight and Final Body Weight |
Total |
|
|||||||||
25M |
26M |
27M |
|||||||||||
Erythema/Eschar Formation |
Imm |
0 |
N/A |
N/A |
N/A |
|
|||||||
1 Hour |
0 |
0 |
0 |
(0) |
|
||||||||
24 Hours |
0 |
0 |
0 |
0 |
|
||||||||
48 Hours |
0 |
0 |
0 |
(0) |
|
||||||||
72 Hours |
0 |
0 |
0 |
0 |
|
||||||||
Oedema Formation |
Imm |
0 |
N/A |
N/A |
N/A |
|
|||||||
1 Hour |
0 |
0 |
0 |
(0) |
|
||||||||
24 Hours |
0 |
0 |
0 |
0 |
|
||||||||
48 Hours |
0 |
0 |
0 |
(0) |
|
||||||||
72 Hours |
0 |
0 |
0 |
0 |
|
||||||||
Sum of 24 and 72 hour Readings (S) |
: |
0 |
|
||||||||||
Primary Irritation Index (S/6) |
: |
0/6 = 0 |
|
||||||||||
Classification |
: |
NON-IRRITANT |
|
||||||||||
|
|||||||||||||
( ) = total values not used for calculation of primary irritation
index
N/A = not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance produced a primary skin irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
As the test material did not produce positive criteria for irritation or corrosiveness in any rabbit according to the EEC labelling regulations and was classified as non-irritant to rabbit skin. No symbol or risk phrases are therefore required.
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