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Diss Factsheets
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EC number: 482-410-3 | CAS number: -
- 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:
- 21 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 48
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Basis for calculation of long-term DNEL for dermal exposure: systemic effects
Rationale for selection of dose descriptor: The test material did produce some reversible ffects (increased liver weights, thymus lymphoid atrophy) at the highest level (1,000 mg/kg bw/day), but not at the lower tested levels. Renal effects at lower dose levels were observed in male rats but were associated with hydrocarbon-induced alpha-2 -microglobulin dependent male rat nephropathy, which is not relevant for humans.
Modification of starting factor: The starting factor needs to be adjusted from seven times per week to five times a week. the tthe test material is expected to be poorly absorbed through skin and dermal penetration through human skin is expected to be considerably less than through rat skin. A modification factor of 2.3 is applied to account for this difference. (CONCAWE DNEL guidance, 2009). Extrapolation from oral to dermal exposure is inherently extremely conservative for the test material.
250 mg/kg * 7d/w / 5d/w * 2.3 = 805 mg/kg
Assessment factors:
Intraspecies = 3 (CONCAWE DNEL guidance 2009)
Interspecies = 4 (CONCAWE DNEL guidance 2009)
Duration = 4 (Subchronic to chronic (R.8, page 35) (90 day is a factor of 2, 28 day is a factor of 6, so assign a 54 day study a factor of 4)
Total = 48 (3)(4)(4) = 48
Basis for calculation of long-term DNEL for inhalationl exposure: systemic effects
Rationale for selection of dose descriptor: the test material did produce some reversible effects (increased liver weights, thymus lymphoid atrophy) at the highest level (1,000 mg/kg bw/day), but not at the lower tested levels. Renal effects at lower dose levels were observed in male rats but were associated with hydrocarbon-induced alpha-2 -microglobulin dependent male rat nephropathy, which is not relevant for humans.
Modification of starting factor: The starting factor needs to be adjusted from seven times per week to five times per week. Additionally the dose needs to be allometrically scaled from rat to human (divide by 0.38 for rat), and adjusted for worker ventilation rate (6.7 m3/ 10 m3).
(250 mg/kg) * (7 days/week/ 5 days/week) * (1/0.38m3/kg) * (6.7m3/10 m3) = 617 mg /m3
Assessment factors:
Intraspecies = 3 (CONCAWE DNEL guidance 2009)
Interspecies = 2.5 (CONCAWE DNEL guidance 2009)
Duration = 4 (Subchronic to chronic (R.8, page 35)90
dats is a factor of 2, 28 day is a factor of 6, so asisgn a 54 day study a factor of 4).Total = 30 (3)(2.5)(4) = 30
Calculation of DNEL: 617 mg/m3 / 15 = 21 mg/m3
Within industry an occupational exposure limit of 5 mg/m3 os generally applied for aerosols of mineral oils since at this concentration the oil is a rather thick fog which may moisten floors and equipment and pose a safety hazard. It is advised to keep the same limit value for the test material.
Reference:
CONCAW DNEL Guidance (2009)
R.8 - ECHA Guidance on information requirements and chemical safety assessment - chapter R.8 - May 2008
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
General population is considered for indirect exposure via the environment only.
Long-term DNEL for general population, oral route, systemic effects: 40 mg/kg/day
Dose descriptor: NOAEL 250 mg/kg/ bw
Basis for dose descriptor: Based on an oral repeate dose study (OECD 422) with Hatcol 1760 in the rat, a NOAEL of 250 mg/kg bw/day was set.
Rationale for selection of dose descriptor:
the test material did produce some reversible effects (increased liver weights, thymus lymphoid atrophy) at the highest level (1,000 mg/kg bw/day), but not at the lower tested levels. Renal effects at lower dose levels were observed in male rats but were associated with hydrocarbon-induced alpha-2 -microglobulin dependent male rat nephropathy, which is not relevant for humans.
Dose descriptor was not a NOAEL at the highest dose tested and was not ≥ limit dose.
Modification of starting factor: It is assumed that dietary exposure is constant throughout the day therefore no time scaling is required.
Assessment factors
Intraspecies = 5 (DNEL guidance Version 3.4)
Interspecies = 4 (DNEL guidance Version 3.4)
Duration = 4 (Subchronic to chronic (R.8, page 35) (90 day is a factor of 2, 28 day is a factor of 6, so assign a 54 day study a factor of 4))
total = 80 (5)(4)(4) = 80
Calculation of DNEL: 250 mg/kg/day / 80 = 3 mg/kg
Reference:
R.8 - ECHA Guidance on information requirements and chemical safety assessment - chapter R.8 - May 2008
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