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Diss Factsheets
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EC number: 235-730-0 | CAS number: 12627-14-4
- 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 (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 20 Oct - 19 Nov 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-study, which meets national standard methods, tested with the source substance AgSil TM 25 Potassium Silicate Solution. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- yes
- Remarks:
- only historical positive control, one dose tested
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 1312-76-1 (content: 30%)
- IUPAC Name:
- 1312-76-1 (content: 30%)
- Details on test material:
- - Name of test material (as cited in study report): AgSil TM 25 Potassium Silicate Solution
- Physical state: claer to hazy white, thick liquid
- Composition of test material, percentage of components: 70% water, 30% silicic acid, potassium salt, potassium silicate
- Lot/batch No.: C052804K1
- Stability under test conditions: stable for the duration of testing
- Storage condition of test material: at room temperature
- Other: ratio: 2.47, pH: 11.3
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, MA, USA
- Age at study initiation: young adult
- Weight at study initiation: 310 - 418 g
- Housing: group housing in stainless steel cages with mesh floors
- Diet (e.g. ad libitum): pelleted Purina guinea pig chow #5025
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by an automatic water dispensing system
- Acclimation period: 3, 6 or 40 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Oct To: 19 Nov 2004
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 100% (undiluted)
Challenge: 75%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 100% (undiluted)
Challenge: 75%
- No. of animals per dose:
- 20 in test group and 10 in naive control group
- Details on study design:
- RANGE FINDING TESTS:
Test to determine the highest non-irrritating concentration of the test substance to be used as challenge dose. The test substance was applied neat (100%) and diluted with distilled water to yield concentrations of 75, 50 and 25% (w/w) to the clipped test side (dorsal area and trunk) using an occlusive Hill Top Chamber. The sites were wrapped with Durapore adhesive tape. After 6h exposure the chambers were gently removed and the test sites were gently cleansed (identical to main study). Approximately 24 h after application, each site was evaluated for local irritation reactions.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test group: near test substance (0.4 mL)
- Control group: no treatment
- Site: left side of each animal
- Frequency of applications: once a week
- Duration: Days 0 - 21
- Concentration: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test group: test substance in distilled water (0.4 mL)
- Control group: test substance in distilled water (0.4 mL)
- Site: right side of each animal
- Concentrations: 75%
- Evaluation (hr after challenge): 24 and 48 h after the challenge application
OTHER: Scoring system
0 - no reaction
0.5 - very faint erythema, usually non-confluent (very faint erythema is not considered a positive reaction)
1 - faint erythema, usually confluent
2 - moderate erythema
3 - severe erythema with or without edema - Positive control substance(s):
- yes
- Remarks:
- technical alpha-hexylcinnamaldehyde (historical control)
Results and discussion
- Positive control results:
- The first and the second reading of the historical positive control group gave 6/10 animals with positive reactions whereas the corresponding negative control group (5 animals) gave no reactions at both time points.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema in 4/10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema in 4/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema in 8/20 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema in 8/20 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- animals were free of irritation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: animals were free of irritation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- one animal with very faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: one animal with very faint erythema.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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