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EC number: 800-035-9 | CAS number: 1374645-21-2
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Lack of data on analytical purity of the test substance. Negative controls were not sham-treated during the induction phase.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Negative controls were not sham-treated during the induction phase. Lack of data on analytical purity of the test substance.
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- niobium oxygen sulfur zinc λ²-stannane
- EC Number:
- 800-035-9
- Cas Number:
- 1374645-21-2
- Molecular formula:
- Sn1.8Zn0.2Nb2O6.8S0.2 (Sn(2-x)Zn(x)Nb2O(7-y)S(y) with x/2 ≤ y, 0.02 ≤ x ≤ 0.22, 0.01 ≤ y ≤ 0.22)
- IUPAC Name:
- niobium oxygen sulfur zinc λ²-stannane
- Details on test material:
- - Name of test material (as cited in study report): Niobium Sulfur Tin Zinc Oxide, EX 1455
- Physical state: solid
- Appearance: powder with lumps
- Analytical purity: no data
- Lot No.: L1903
- Stability under test conditions: The test substance was expected to be stable under the test conditions.
- Storage condition of test material: at room temperature
- Solubility: insoluble
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs
- Age at study initiation: young adult
- Weight at study initiation: 352 - 456 g
- Housing: The animals were housed in groups in suspended stainless steel cages with mesh floors or perforated plastic bottoms. Litter paper was placed beneath the cages and changed at least three times per week.
- Diet: Harlan Teklad Global Guinea Pig Diet #2040, portions of approximately 20 g/d
- Water: filtered tap water, ad libitum
- Acclimation period: 15 - 23 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -23
- Humidity (%): 41 - 62
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Concentration / amount:
- Induction: 84% (w/w) mixture of the test substance in vehicle
Challenge: 84% (w/w) mixture of the test substance in vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Concentration / amount:
- Induction: 84% (w/w) mixture of the test substance in vehicle
Challenge: 84% (w/w) mixture of the test substance in vehicle
- No. of animals per dose:
- 10 (controls), 20 (test groups)
- Details on study design:
- RANGE FINDING TESTS:
To find a suitable concentration for the challenge, 4 animals were treated with different concentrations in vehicle. Therefore, the fur on the dorsal area and flanks of each guinea pig was removed by clipping. The area was divided in four test sites on each animal. Mixtures of the test substance with the vehicle yield 84%, 63%, 42% and 21%. 400 mg of each concentration was applied to a test site using an occlusive 25 mm Hill Top Chamber. After 6 h exposure, the chambers were removed and the application sites were cleaned. After 24 h, each site was evaluated for erythema.
The highest non-irritating dose was 84% of the test substance in the vehicle. This concentration was used for the challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.4 g of a mixture of the test substance in 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Site: left side, using an occlusive 25 mm Hill Top Chamber
- Frequency of applications: every 7 d for 3 weeks
- Duration: 6 h
- Concentrations: 84% (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: 0.4 g of a mixture of the test substance in 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Control group (naive): 0.4 g of a mixture of the test substance in 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Site: right side, using an occlusive 25 mm Hill Top Chamber
- Concentrations: 84% (w/w)
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Challenge controls:
- As control group, 10 naive guinea pigs from the same shipment were treated with 84% of the test substance in vehicle for 6 h.
- Positive control substance(s):
- yes
- Remarks:
- historical positive control: alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The procedures used in this study were validated using the positive control substance alpha-Hexylcinnamaldehyde. The most recent validation of the test system was performed between 11 Oct and 11 Nov 2011. The positive control substance induced positive reactions in 3/10 animals (30%) thus meeting the reliability criteria for the Buehler test (≥ 15%).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 84%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 84%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 84%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 84%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
During the induction phase, 5/20 test animals showed very faint erythema 24 h after the treatment. These effects were reversible in 4/5 animals after 48 h. In none of the other animals treated with the test substance any effects were observed.
In 3/20 test group animals and 2/10 naive control animals, very faint erythema were observed 24 h after the challenge phase. These effects were reversible at the second reading timepoint 48 h after the challenge. The very faint erythema observed 24 h after the challenge were not considered to be a positive reaction.
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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