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EC number: 231-975-2 | CAS number: 7783-03-1
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2002-07-22 to 2002-11-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, scientifically sound study that was conducted in accordance to GLP, OECD guideline 406 and Directive 96/54/EC, B.6, "Skin Sensitisation." The reliability of this study for the substance tested is a K1, but in application of read-across to a different substance, ECHA's guidance specifies that the score can be a maximum of a K2.
- Justification for type of information:
- Tungstic acid (WO3•H2O) is the hydrated form of tungsten trioxide (WO3). Based on Annex V, hydrates and water free forms (anhydrous) of compounds can be regarded as the same substance for registration purposes. Therefore, tungstic acid will be considered equivalent to WO3. For more details on the rationale, refer to the attached description of the read-across approach (Annex 3).
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A 2002 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:
- Tungsten trioxide
- EC Number:
- 215-231-4
- EC Name:
- Tungsten trioxide
- Cas Number:
- 1314-35-8
- Molecular formula:
- O3W
- IUPAC Name:
- trioxotungsten
- Details on test material:
- - Name of test material (as cited in study report): Tungsten Oxide (WO3)
- Supplier: Sponsor
- Physical state: Yellow to greenish powder
- Analytical purity: 99.88%
- Purity test date: 2002-05-28
- Stability under test conditions: 5 years
- Storage condition of test material: Room temperature
- Solubility in water: < 10 mg/L at 20 degrees C
- pH: 6.1 (aqueous solution)
- Melting point: Appox. 1473 degrees C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: Approximately 5-7 weeks
- Weight at study initiation: 316-404 g
- Housing: Until day 0- housed singly in Makrolon cages type III; From day 0- group caging in plastic containers (6 control or 11 test substance animals per container)
- Diet (eg ad libitum): Altromin Maintenance Diet No. 3122- ad libitum
- Water (eg ad libitum): Tap water offered in Makrolon bottles with stainless steel canules- ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average 22.0 ⁰C (step one), Average 21.9 ⁰C (step two)
- Humidity(%): Average 59.9% (step one), Average 56.4% (step two)
- Air changes (per hr): 12/hr
- Photoperiod (hrs dark / hrs light): 12 dark/12 light (6 am to 6 pm)
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% w/w
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% w/w
- No. of animals per dose:
- 2 x 10 animals for the substance group
2 x 5 animals for the control group - Details on study design:
- RANGE FINDING TESTS: Preliminary test with 2 female guinea pigs. FCA was administered intradermally and immediately after, the test substance was administered (50% in white petrolatum, w/w) epicutaneously to the sites of the intradermal injections to examine possible systemic effects. 7 days later 4 concentrations of the test substance were administered epicutaneously for 24 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 hours (exposure 1), 48 hours (exposure 2)
- Test groups: 2 groups both dosed at 50% w/w
- Control group: Dosed with white petrolatum only
- Site: Shaved, 2 cm x 4 cm filter papers with test substance applied and fixed with non-irritating tape (interscapular region)
- Frequency of applications: Day 0 and day 8
- Duration: 25 days
- Concentrations: 50% w/w or 0% w/w
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups: 2 groups both dosed at 50% w/w
- Control group: dosed with white petrolatum only
- Site: Shaved, 2 cm x 2 cm filter papers with test substance applied and fixed with non-irritating tape to the left flanks and vehicle to the right flanks.
- Concentrations: 50% w/w
- Evaluation (hr after challenge): 3 hours after end of challenge exposure
OTHER: Intradermal injections of FCA were administered directly before epicutaneous exposures. Also, before the second induction exposure, the animals were pretreated with n-dodecylsulfate, sodium salt (10% in white petrolatum, w/w).
Positive Control: Concentrations of HCA
10 females for the positive control substance group and 5 females for the negative control group.
70% in acetone (v/v) for the 1st epicutaneous induction
70% in acetone (v/v) for the 2nd epicutaneous induction
20% in acetone (v/v) for the challenge exposure - Challenge controls:
- Blind reading of test and control animals. All animals administered 50% in white petrolatum, w/w epicutaneously.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (HCA)
Results and discussion
- Positive control results:
- 7/10 animals (70%) represented also the net rate of animals sensitised by HCA.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive skin reaction in any animal at any reading time
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. Hours after challenge: 24. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No positive skin reaction in any animal at any reading time .
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive skin reaction in any animal at any reading time
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No positive skin reaction in any animal at any reading time
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Hours after challenge: 24 Group: negative control. Dose level: 0 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No positive skin reaction in any animal at any reading time.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No positive skin reaction in any animal at any reading time
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Hours after challenge: 48 Group: negative control. Dose level: 0 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No positive skin reaction in any animal at any reading time.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 70% in actone
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Very slight to severe erythema and/or oedema in 7/10 animals 24 and/or 48 hours after challenge exposure
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 70% HCA for induction and 20% HCA for challenge
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Very slight to severe erythema and/or oedema in 7/10 animals 24 and/or 48 hours after challenge exposure
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Mortality
All animals survived till the end of the study.
Body weight
- Step 1: There were no significant differences in the mean body weights between the animals of the test substance group and those of the control group on Days 0 and 25.
- Step 2: There were no significant differences in the mean body weights between the test substance group and the control group on Day 0. On Day 25 the mean body weight of the test substance group animals was slightly, but statistically, higher than that of the control animals. This was of no biological significance and was regarded as a random event.
General observations
Immediately after the beginning of all epicutaneous exposures (inductions, challenge) the motor activities of all animals were increased. This is due to the dressings which restrict the freedom of movement. Soon afterwards the behaviour was regular again. Except of the observations described above no abnormal behaviour or clinical signs were detected during the experiment in the animals.
Skin reactions after the intradermal FCA administration
Cranial and caudal injection sites: Local irritations were observed in all animals beginning on the day after the injections. The irritations started with local erythema, which became more severe and led to ulcerations. Lesions did not heal until the end of the study. These local alterations are known effects of Freund's adjuvant.
Skin reactions after the first and the second induction exposure
All animals of both groups had severe erythema and oedema in the interscapula region which were attributed to the effects of the adjuvant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the animals in the test substance group were regarded as sensitised.
- Executive summary:
No skin sensitisation data are available for tungstic acid (target substance). However, skin sensitisation data are available for tungsten trioxide (source substance), which were used for read-across. Tungstic acid (WO3•H2O) is the hydrated form of tungsten trioxide (WO3). Based on Annex V, hydrates and water free forms (anhydrous) of compounds can be regarded as the same substance for registration purposes. Therefore, tungstic acid is considered equivalent to WO3. For more details on the rationale, refer to the attached description of the read-across approach.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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