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Diss Factsheets
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EC number: 680-341-5 | CAS number: 41438-38-4
- 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:
- 4.29 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 429.77 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No data are available to evaluate the long term inhalation toxicity.
No data are available to evaluate the long term inhalation toxicity.
According to column 2 part 8.5.2 "testing by the inhalation route is appropriate if exposure of humans via inhalation is likely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
The test substance at room temperature can have different aspects: amorphous solid with better crystallized parts (brown to yellow staining), yellow liquid if it remained supercooled appearance. The melting point is 29.5 °C. No particle size could be evaluated because of the liquid supercooled form. No aerosol are expected. The calculation of the vapor pressure of MEXORYL SBU at 25 °C by interpolation based upon the simplified Clausius-Clapeyron equation resulted in a vapor pressure of 2.2 x 10-2 Pa at 25 °C. Based on ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.14: Occupational exposure estimation", Table R.14-4, the "low vapour pressure " regarding fugacity and dustiness is being defined as the vapour pressure range upper or equal to 0.00001 and lower than 0.5 kPa. So MEXORYL SBU has a low fugacity. A low exposure by inhalation is expected furthermore, according to long term dermal toxicity data available no toxic effects are expected, a route to route extrapolation could be done for DNEL calculation.
According to column 2 part 8.5.2 "testing by the inhalation route is appropriate if exposure of humans via inhalation is likely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The test substance at room temperature can have different aspects: amorphous solid with better crystallized parts (brown to yellow staining), yellow liquid if it remained supercooled appearance. The melting point is 29.5 °C. No particle size could be evaluated because of the liquid supercooled form. No aerosol are expected. The calculation of the vapor pressure of MEXORYL SBU at 25 °C by interpolation based upon the simplified Clausius-Clapeyron equation resulted in a vapor pressure of 2.2 x 10-2 Pa at 25 °C. Based on ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.14: Occupational exposure estimation", Table R.14-4, the "low vapour pressure " regarding fugacity and dustiness is being defined as the vapour pressure range >=0.00001- <0.5 kPa. So MEXORYL SBU has a low fugacity. A low exposure by inhalation is expected furthermore, according to long term dermal toxicity data available no toxic effects are expected, a route to route extrapolation could be done for DNEL calculation.
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value
- 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
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
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:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract
- AF for intraspecies differences:
- 5
- Justification:
- default value worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The potential of the undiluted test item Mexoryl SBU to induce ocular irritation was evaluated in three rabbits according OECD and EC guidelines. Mean scores calculated for each animal over 24, 48 and 72 hours were 3.0, 1.3 and 2.0 for chemosis, 3.0, 2.0 and 2.0 for redness of the conjunctivae, 1.0, 0.0 and 1.0 for iris lesions and 1.7, 1.7 and 2.0 for corneal opacity.
Under applied experimental conditions, the test item Mexoryl SBU is irritant when administered by ocular route to rabbits.General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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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