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EC number: 237-623-4 | CAS number: 13870-28-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- positive control: p-phenylenediamine
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Disodium disilicate
- EC Number:
- 237-623-4
- EC Name:
- Disodium disilicate
- Cas Number:
- 13870-28-5
- Molecular formula:
- Na2Si2O5
- IUPAC Name:
- disodium disilicate
- Details on test material:
- - Name of test material (as cited in study report): Layered Silicate SKS-6
- Physical state: solid, powder
- Colour: white
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, D-33178 Borchen, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 18 - 22 g
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 6.25%, 12.5% and 25%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: maximum 25%
- Irritation: no
MAIN STUDY:
- Evaluation:
Proliferative response of lymph node cells:
DPM/NODE = number of radioactive disintegrations per minute per lymph node;
STIMULATION INDEX = ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to that recorded for control group animals. Background values were subtracted.
EC3 values are determined by linear interpolation {EC3=c+[(3-d)/(b-d)]x(a-c)}, between two points of the stimulation indices axis, one above (a,b) and one below (c,d) the stimulation index of three. If all measured points are above or below the stimulation index of three, no EC3 value can be stated.
- Criteria used to consider a positive response: Stimulation Index ? 3.0 - Positive control substance(s):
- other: p-phenylenediamine 1%
- Statistics:
- NA
Results and discussion
- Positive control results:
- Mean values (SD): DPM: 14552.2 (2997.6), DPM/node: 7265.3 (1498.8), Stimulation Index: 12.0 (2.5)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: c = 6.25%: SI = 0.7 ±0.3 c = 12.5%; SI = 0.6 ± 0.1 c = 25%; SI = 0.7 ± 0.2
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 6.25%; mean values (SD): DPM: 822.8 (393.6); DPM/node: 384.7 (196.8) 12.5%; mean values (SD): DPM: 748.0 (117.4); DPM/node: 347.3 (58.7) 25%; mean values (SD): DPM: 834.0 (221.4); DPM/node: 390.3 (110.7)
Any other information on results incl. tables
Radioactive Determination of the Test Substance Groups
POS |
CPM |
Test Item |
Conc. [%] |
Animal number |
DPM |
DPM- mean back- ground |
DPM/ Node |
Stimulation Index |
18 |
457.0 |
Negative Control |
|
16 |
950.0 |
896.6 |
448.3 |
|
19 |
701.0 |
17 |
1467.0 |
1413.6 |
706.8 |
|
||
20 |
486.0 |
18 |
1017.0 |
963.6 |
481.8 |
|
||
21 |
444.0 |
19 |
931.0 |
877.6 |
438.8 |
|
||
22 |
860.0 |
20 |
1795.0 |
1741.6 |
870.8 |
|
||
MV |
589.6 |
MV |
1232.0 |
1178.6 |
589.3 |
1.0 |
||
SD |
164.3 |
SD |
343.1 |
343.1 |
171.5 |
|
||
61 |
340.0 |
disodium disilicate (delta-crystalline) |
6.25 |
1 |
722.0 |
668.6 |
334.3 |
0.6 |
62 |
67.0 |
2 |
143.0 |
89.6 |
44.8 |
0.1 |
||
63 |
438.0 |
3 |
927.0 |
873.6 |
436.8 |
0.7 |
||
64 |
626.0 |
4 |
1338.0 |
1284.6 |
642.3 |
1.1 |
||
65 |
469.0 |
5 |
984.0 |
930.6 |
465.3 |
0.8 |
||
MV |
388.0 |
MV |
822.8 |
769.4 |
384.7 |
0.7 |
||
SD |
185.0 |
SD |
393.6 |
393.6 |
196.8 |
0.3 |
||
66 |
386.0 |
disodium disilicate (delta-crystalline) |
12.5 |
6 |
820.0 |
766.6 |
383.3 |
0.7 |
67 |
263.0 |
7 |
553.0 |
499.6 |
249.8 |
0.4 |
||
68 |
406.0 |
8 |
856.0 |
802.6 |
401.3 |
0.7 |
||
69 |
1275.0* |
9 |
|
|
|
|
||
70 |
363.0 |
10 |
763.0 |
709.6 |
354.8 |
0.6 |
||
MV |
354.5 |
MV |
748.0 |
694.6 |
347.3 |
0.6 |
||
SD |
55.0 |
SD |
117.4 |
117.4 |
58.7 |
0.1 |
||
73 |
576.0 |
disodium disilicate (delta-crystalline) |
25 |
11 |
1199.0 |
1145.6 |
572.8 |
1.0 |
74 |
335.0 |
12 |
704.0 |
650.6 |
325.3 |
0.6 |
||
75 |
341.0 |
13 |
719.0 |
665.6 |
332.8 |
0.6 |
||
76 |
277.0 |
14 |
581.0 |
527.6 |
263.8 |
0.4 |
||
77 |
463.0 |
15 |
967.0 |
913.6 |
456.8 |
0.8 |
||
MV |
398.4 |
MV |
834.0 |
780.6 |
390.3 |
0.7 |
||
SD |
107.5 |
SD |
221.4 |
221.4 |
110.7 |
0.2 |
||
90 |
23.0 |
Background Szinti and TCA |
|
|
47.0 |
|
|
|
91 |
27.0 |
|
55.0 |
|
|
|
||
92 |
29.0 |
|
60.0 |
|
|
|
||
93 |
29.0 |
|
61.0 |
|
|
|
||
94 |
21.0 |
|
44.0 |
|
|
|
||
MV |
25.8 |
MV |
53.4 |
0.0 |
0.0 |
0.0 |
||
SD |
3.2 |
SD |
6.8 |
|
|
|
*outlier failed Grubbs, Nalimov,
POS = position in counter; CPM = counts per minute; Conc. = concentration;
DPM = disintegrations per minute; SD = standard deviation; MV = mean value;
Szinti = scintillation fluid; TCA = trichloroacetic acid
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance does not meet the criteria for EU or GHS-EU classification.
- Executive summary:
Materials and methods
Based on the results of a preliminary test the test item was assessed for sensitising properties at concentrations of 0 (vehicle only), 6.25%, 12.5% and 25% (v/v) in an LLNA according to OECD 429. The study was performed on female CBA/CaOlaHsd mice; 5 animals were used per group. Acetone/olive oil (4:1 (v/v)) was used as vehicle. General clinical signs and mortality as well as bodyweight development were monitored during the study.
Results and Discussion
At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality were observed. Body weight development was unaffected.
None of the three tested concentrations of the test item reached the stimulation index of 3. The stimulation indices were: at a concentration of 6.25% = 0.7; at a concentration of 12.5% = 0.6 and at a concentration of 25% = 0.7. The EC3 value could not be calculated.
The test item is regarded to have no skin sensitising properties.
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