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Diss Factsheets
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EC number: 231-143-9 | CAS number: 7440-33-7
- 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
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Endpoint summary
Administrative data
Description of key information
Tungsten metal powder was deemed to be not sensitising following a skin sensitisation study conducted on guinea pigs according to OECD Guideline 406.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-03-31 to 1999-04-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented OECD guideline study performed under GLP.
- 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. - 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 wks
- Weight at study initiation: 371 to 436 g
- Housing: In groups of five in suspended metal cages with wire mesh floors.
- Diet: ad libitum Vitamin C enriched (Harlan Teklad 9600 FD2 SQC). Hay was given thrice weekly.
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 25.5
- Humidity (%): 37 to 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 1998-03-31 to: 1998-05-01 - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% w/v in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% w/v in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% hexyl cinnamic aldehyde (HCA) in Alembicol D - Not concurrent
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Clinical observations:
- Dryness and sloughing of the epidermis
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under conditions of this study, Tungsten metal powder did not produce evidence of skin sensitisation (delayed contact hypersensitivity).
Reference
RESULTS
Dermal reactions seen following the induction:
- Intradermal injections:
Necrosis was recorded at most sites receiving Freund's Complete Adjuvant in both test and control animals.
Slight irritation was seen in most test animals at sites receiving Tungsten metal powder (20% w/v) in sterile water. No irritation was observed in control animals receiving sterile water for injection.
Topical application:
Slight erythema was observed in most test animals following topical application with Tungsten metal powder, 70% w/v in distilled water. Slight erythema was also seen in most of the control guinea-pigs after topical application of distilled water alone.
- Dermal reactions elicited by the challenge applications:
No dermal reactions were seen in any of the test or control animals.
BODYWEIGHT
Bodyweight increases were recorded for all guinea pigs over the period of the study.
CLINICAL SIGNS
No signs of ill health or toxicity were recorded.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Although no study data specifically evaluating the potential respiratory sensitisation effects are available, based on the lack of human case reports indicating that tungsten metal is a respiratory sensitiser, as well as negative responses observed in both the skin sensitisation and skin irritation animal studies, tungsten metal is not likely to be a respiratory sensitiser.
Justification for classification or non-classification
A skin sensitisation test of sufficient quality and tested in accordance with standard methodology was available for tungsten metal. The results of this study showed that tungsten metal did not cause skin sensitisation in Guinea Pigs. Therefore, no classification is warranted for the skin sensitisation endpoint. No respiratory sensitization study is available for tungsten metal. Therefore, classification cannot be made due to lack of data. However, this endpoint is not required for REACH registration.
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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