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Diss Factsheets
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EC number: 231-193-1 | CAS number: 7446-07-3
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human".
The most sensitive endpoint is the oral repeated dose toxicity (NOAEL= 25 mg/kg/day). The more sensitive NOAEL for reprotoxicity is not selected due to adverse effects are specific to the developing organism.
Starting point: Derived oral NOAEL in rats: 25 mg/kg/d -> NOAEL human = 25/4 = 6.25 mg/kg/d; NOAEC worker (8 h) = NOAEL x 70/10 = 6.25 x 70/10 = 43.75 mg/m3.
The applied factors can be derived from the flow chart below. As first approach the route to route extrapolation from oral to inhalation is based on a comparable resorption for both pathways.
Explanation of factors:
4: Transfer rat->human
70: human bodyweight
10: daily respiration volume (workers per work shift)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute->chronic, default value according to ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).
In the evaluated scenarios only dry expsosure to Tellurium dioxide dust is relevant. The Health Risk Assessment Guidance for Metals (HERAG) proposes for the dermal absorption after exposure to dust or other dry metal compounds a default value of 0.1 % (see also HERAG fact sheet - assessment of occupational dermal exposure and dermal absorption for metal cations and inorganic metal substances; EBRC Consulting GmbH / Hannover /Germany; August 2007) . The starting point of the DNEL-derivation comes from an oral study on rats. As discussed in the chapter "Toxicokinetics" the bioavailability of Tellurium dioxde after oral uptake is considered to be lower than 25 %. An in vitro study stated a bioavailability in artificial gastrointestinal fluid of approx. 3 % after 24h. Typically such an in vitro study may underestimate the bioavailabilty in humans, the realistic bioavailability after oral ingestion may be between 3 % and 25 %. Based on this bandwidth the dermal bioavailability is estimated with 10 % of the oral biovailability and the extrapolated dermal NOAEL is stated with 250 mg/kg bw per day.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute->chronic, default value according to ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat-> human; Default value according to ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The derivation of DNELs is based on available toxicological data and the toxicokinetic behaviour of tellurium compounds.
Critical parameters for DNEL derivations
NOAEL for Tellurium dioxide: 25 mg/kg bw/d
Extrapolation for time scaling subacute -> chronic: factor 6
Therefore the chronic NOAELoral after time scaling is:
25 mg/kg bw/day /6 = 4.17 mg/kgbw/day
The derived NOAEL for developmental toxicity was stated with 3.19 mg Tellurium dioxide/kg body weight per day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human".
Starting point: Derived oral NOAEL in rats: 25 mg/kg/d -> NOAEL human = 25/4 = 6.25mg/kg/d; NOAEC general population (24 h) = NOAEL x 70/20 = 6.25 x 70/20 = 21.88 mg/m3.
The applied factors can be derived from the flow chart below. As first approach the route to route extrapolation from oral to inhalation is based on a comparable resorption for both pathways.
Explanation of factors:
4: Transfer rat->human
70: human bodyweight
20: daily respiration volume (general population for 24 h)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute->chronic, default value according to ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).
In the evaluated scenarios only dry expsosure to Tellurium dioxide dust is relevant. The Health Risk Assessment Guidance for Metals (HERAG) proposes for the dermal absorption after exposure to dust or other dry metal compounds a default value of 0.1 % (see also HERAG fact sheet - assessment of occupational dermal exposure and dermal absorption for metal cations and inorganic metal substances; EBRC Consulting GmbH / Hannover /Germany; August 2007) . The starting point of the DNEL-derivation comes from an oral study on rats. As discussed in the chapter "Toxicokinetics" the bioavailability of Tellurium dioxde after oral uptake is considered to be lower than 25 %. An in vitro study stated a bioavailability in artificial gastrointestinal fluid of approx. 3 % after 24h. Typically such an in vitro study may underestimate the bioavailabilty in humans, the realistic bioavailability after oral ingestion may be between 3 % and 25 %. Based on this bandwidth the dermal bioavailability is estimated with 10 % of the oral biovailability and the extrapolated dermal NOAEL is stated with 250 mg/kg bw per day.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute->chronic, default value according to ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat-> human, default value according to ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see chapter "toxicokinetics"
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute->chronic, default value according to ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat-> human, default value according to ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value according to ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default value according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Critical parameters for DNEL derivations
NOAEL for Tellurium dioxide: 25mg/kg bw/d from an oral study with rats.
Extrapolation for time scaling subacute -> chronic: factor 6
Therefore the chronic NOAELoral after time scaling is:
25 mg/kg bw/day /6 = 4.17 mg/kg bw/day
Doses for adverse effects derived from the reproductive/developmental screening toxicity is 3.19 mg Tellurium dioxide/kg body weight per day and for this endpoint a time scaling is not required.
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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