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Diss Factsheets
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EC number: 247-415-5 | CAS number: 26021-57-8
- 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:
- 0.12 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8.82 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Data used for the calculation:
The Relevant dose descriptor: NOAEL: 10 mg/kg/bw based on microscopic findings in the kidneys observed with a dose-related incidence and severity at 100 and 1000 mg/kg/day in 28 days repeated dose toxicity study on rat Sprague Dawley OFA, receiving the substance in suspended 2 % Polysorbate 80 sterile water hydrogel (containing dimethicone) at doses: 0, 10, 100 and 1000 mg/kg bw/day in a volume of 10 mg/kg bw.Route to route extrapolation: NOAEC = NOAEL x (1/sRV(rat)) x (sRVhuman/wRV) x (ABSoral/ABSinhal.)
NOAEC = 10 mg/kg/day x (1/0.38 m3/kg/bw) x (6.7 m3/10 m3) x (50%*/100%) = 8.82 mg/m3*oral bioavailability as determined in toxicokinetic study, by default, inhalation bioavailability is supposed to be 100%.
In absence of toxicokinetic data, 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation. (Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health)
The Assessment factor = 1 x 2.5 x 5 x 6 x 1 x 1 = 75
Worker-DNEL long term inhalation systemic= 8.82 mg/m3 / 75
Worker-DNEL long term inhalation systemic= 0.12 mg/m3- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 6
- Justification:
- default value for extrapolation subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Extrapolation from oral to inhalation route (example B3 of guidance R8))
- AF for other interspecies differences:
- 2.5
- Justification:
- R8 ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 353 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.41 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL = 500 mg/kg bw.
Calculation: according to ECHA guidance document R8, the rat respiratory volume is 0.2L/min/rat that mean for 4h: 0.2x 60x 4 = 48 L. The maximum achievable exposure regarding required 5 mg/L for 4 hours (OECD 403: 48 L x 5 mg/L = 240 mg/rat). 240 mg/0.250 kg bw = 960 mg/kg bw maximum achievable exposure
Oral Bioavailability = 50% (default value) Inhalation Bioavailability: Assumed to be 100% Determination of the correction factor oral vs. inhalation route: 50% oral vs. 100% inhalation = 0.50
NOAEC calc inhal.: 500 mg/kg bw x 0.250 kg bw x 0.5/48 L = 1.30 mg/L for 4h supposed exposure.
For the DNEL derivation the first step is to modify the starting point Rat NOAEC (4h) into NOAEC worker (4h), according to ECHA guidance on information requirements and chemical safety assessment R8. Rat NOAEC (4h) = 1.30 mg/L --> inhalation NOAEC worker (4h) = 1.30 mg/L x (sRVhuman/wRV) sRVhuman: standard respiratory volume for human: 6.7 m3 wRV: worker respiratory volume for 4 hours: 5 m3 --> NOAEC worker (4h) = 1.30 x (6.7/5) = 1.75 mg/L
NOAEC free base worker (4h) = 1.75 mg/L Conversion of the NOAEC for 4 hours to NOAEC for 15 minutes using Haber low: Haber law Cn x t = k with n=3 for extrapolation from longer to shorter duration: (1.75)3 x 4 x 60 = k = 1286.25 NOAEC (15 min) = 3√(1286.25/15) = 4.41 mg/L, NOAEC free base worker (15 min). Overall assessment factors (AS): 125 DNEL (4h) = NOAEC / AS = 4.41 / 12.5 = 0.353 mg/L = 353 mg/m3 Worker-DNEL acute for inhalation route-systemic (15 min) = 353 mg/m3.
This value is indicative and qualitative evaluation should also be considered.- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Extrapolation from oral to inhalation route (example B3 of guidance R8)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.894 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 227.27 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Further explanation on hazard conclusions:
In absence of toxicokinetic data, 50% (instead of 100%) absorption is assumed for oral absorption, and 2.2% for dermal exposure.
NOAEL: 10 mg/kg/bw based on microscopic findings in the kidneys observed with a dose-related incidence and severity at 100 and 1000 mg/kg/day in 28 days repeated dose toxicity study on rat Sprague Dawley OFA, receiving the substance in suspended 2 % Polysorbate 80 sterile water hydrogel (containing dimethicone) at doses: 0, 10, 100 and 1000 mg/kg bw/day in a volume of 10 mg/kg bw.
Determination of the correction factor oral vs. dermal route 50 % oral vs. 2.2 % dermal = 10 * (50/2.2) = 227.27 mg/kg bw /d NOAEL dermal
Assessment factor = 1x6x1x4x5x1x1 = 120
Worker DNEL for long term dermal route = 227.27 mg/kg /120
Worker DNEL for long term dermal route: 1.894 mg/kg bw- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 6
- Justification:
- default value for extrapolation subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value
- AF for other interspecies differences:
- 4
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value for worker
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default factor
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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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