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EC number: 236-743-4 | CAS number: 13472-45-2
- 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
- Study period:
- 1998-03-24 to 1999-04-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was performed according to OECD Guideline for Testing of Chemicals No. 406 "Skin Sensitization" and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A 1999 guinea pig sensitisation study was available of good quality. Therefore, there is no need to conduct a LLNA study as the guinea pig sensitisation study scientifically fulfills the endpoint. The OECD 406 method provides sensitisation information likely to arise from exposure to test substance via intradermical injection and/or epidermical application to guinea pigs. The guinea pig sensitisation test detects chemicals with moderate to strong sensitisation potential, as well as those with relatively weak sensitisation potential. In such methods activity is measured as a function of challenge-induced dermal hypersensitivity reactions elicited in test animals compared with controls. In addition, guinea pigs have been the animal of choice for predictive sensitisation tests for several decades (way before the LLNA became the test of choice).
The existing guinea pig data submitted here is of good quality as clear results are presented in this robust summary and test methodology followed OECD 406 guidelines, and conducted under GLP. This study it is considered acceptable according to page 266 in ECHA's Chapter r7a on Guidance on Information Requirements and Chemical Safety Assessment.
Test material
- Reference substance name:
- Disodium wolframate
- EC Number:
- 236-743-4
- EC Name:
- Disodium wolframate
- Cas Number:
- 13472-45-2
- Molecular formula:
- Na2WO4
- IUPAC Name:
- disodium dioxotungstenbis(olate)
- Details on test material:
- - Name of test material (as cited in study report): Sodium Tungstate Dihydrate
- Substance type: Active
- Physical state: White Powder
- Analytical purity: 99.9%
- Storage condition of test material: Room Temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffs, UK.
- Age at study initiation: 4 to 7 weeks
- Weight at study initiation: 419 to 527 g
- Housing: Five suspended metal cages with wire mesh floors.
- Diet: Vitamin C enriched guinea-pig diet (Harlan Teklan 9600 FD2 SQC) - ad libitum. Hay was given thrice weekly.
- Water: ad libitum.
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.5 to 23.5
- Humidity (%): 40 to 59%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1998-03-24 To: 1998-04-24
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Distilled water
- Concentration / amount:
- Induction intradermal injection: 5% w/v in sterile water for injection.
Induction topical application: 75% w/v in distilled water.
Topical challenge: 5 and 2.5% w/v in distilled water.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Distilled water
- Concentration / amount:
- Induction intradermal injection: 5% w/v in sterile water for injection.
Induction topical application: 75% w/v in distilled water.
Topical challenge: 5 and 2.5% w/v in distilled water.
- No. of animals per dose:
- 10 animals.
- Details on study design:
- RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the topical route of administration for the challenge phase.
Animals for these investigations were pre-treated with an intradermal injection of Freund's complete adjuvant, 50:50 with water for irrigation (Ph. Eur.), approximately two weeks prior to the start of the preliminary investigations.
MAIN STUDY
A. INDUCTION INTRADERMAL EXPOSURE
- No. of exposures: Three pairs
- Test groups: 0.1 mL of FCA 50:50 with sterile water; 0.1 mL of test substance, 5% w/v in sterile water; 0.1 mL of test substance, 5% w/v in 50:50 mixture of FCA and sterile water for injection.
- Control groups: 0.1 mL of FCA 50:50 with sterile water, 0.1 mL of sterile water, and 0.1 mL of FCA 50:50 with sterile water.
- Site: Scapular area
- Concentrations: 5% w/v
MAIN STUDY
A. INDUCTION TOPICAL EXPOSURE
- No. of exposures: One
- Test groups: 0.4 mL of test substance, 75% w/v in distilled water
- Control group: Concurent no treatment.
- Site: Interscapular area
- Duration: 48 hours
- Concentrations: 75% w/v
B. CHALLENGE EXPOSURE
- No. of exposures: Single
- Test groups: 0.2 mL of test substance, 5% w/v in distilled water and 0.2 mL of test substance, 2.5% w/v in distilled water.
- Control group: Same as test group.
- Site: Anterior site on the flank and posterior site on the flank respectively.
- Concentrations: 5% w/v and 2.5% w/v respectively.
- Evaluation (hr. after challenge): two weeks - Challenge controls:
- Control animals were not exposed within either induction period. Animals were exposed to the same concentrations of test substance as test animals.
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde (HCA), Benzocaine and 2-mercaptobenzothiazole (MBT)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 mL of 2.5 and 5% w/v sodium tungstate in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of ill health or toxicity were observed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 mL of 2.5 and 5% w/v sodium tungstate in distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of ill health or toxicity were observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 mL of 2.5 and 5% w/v in distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no signs of ill health or toxicity were observed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 mL of 2.5 and 5% w/v in distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of ill health or toxicity were observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Localised dermal reaction (restricted to a small area of the challenge site); dryness sloughing of the epidermis
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- positive indication of skin sensitisation Reactions in anterior site, exposed to HCA (as supplied) and posterior site, exposed to HCA, 50% in Alembicol D
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Distilled water - 0.1 ml
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Clinical observations:
- Slight irritation
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- no indication of skin sensitisation
Any other information on results incl. tables
CLINICAL SIGNS:
No signs of ill health or toxicity were recorded.
INDUCTION:
-Intradermal injections: Necrosis was recorded at most sites receiving FCA in test and control animals. Slight to well-defined irritation was seen in test animals at sites receiving the test substance, 5% w/v in sterile water for injection. No irritation was observed in control animals receiving sterile water for injection.
-Topical application: Slight to well-defined erythema was observed in test animals following topical application with the test substance, 75% w/v in distilled water. Slight erythema was seen in most of the control guinea-pigs.
CHALLENGE:
There were no dermal reactions seen in any of the test or control animals. All ten test animals gave negative responses.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not produce evidence of skin sensitization (delayed contract hypersensitivity) in any of the ten test animals under the conditions of the assay.
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