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Diss Factsheets
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EC number: 248-324-3 | CAS number: 27206-35-5
- 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:
- 98.74 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):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 234.21 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Due to the low vapour pressure and its physical state (solid) of the test substance acute exposure hazard via inhalation is unlikely for humans and hence, repeated dose toxicity testing via the inhalation route was not done. Therefore a route-to-route extrapolation from an oral repeated dose study, as a worst case, is justified.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- No additional AF required as NOAEL is already derived from a chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling should be applied in case of oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- default (database is of high quality)
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 70 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on dermal toxicity is available and required, so only oral toxicity data can be used.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- No additional AF required as NOAEL is already derived from a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for allometric scaling (rat to human) as given in ECHA guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- default (database is of high quality)
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- medium hazard (no threshold derived)
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 calculation of the DNELs is performed in accordance with the principles given in ECHA (2008) “Guidance of Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.”
Available dose descriptors:
For SPS, DNELs are needed for chronic exposure by the oral (only for consumers), dermal (for workers and consumers) and inhalation routes of exposure (workers and consumers). Inhalation is not a relevant route of exposure due to the low vapour pressure and the physical state (solid) of the substance. Since SPS does not represent an acute hazard (not classified for acute toxicity), no DNELs for acute systemic toxicity need to be derived.
No DNELs are needed for local effects because there is no dose-response and route-specific information on these endpoints, and no skin irritating effects were observed. Long-term systemic DNELs cover sufficiently local effects.
From all available data for the different human health endpoints it is clear that SPS exerts its effect by a threshold mode of action. Thus, DNELs can be calculated for the different threshold endpoints based on the most relevant dose descriptors per endpoint. DNELs are derived based on the available toxicity data for the substance, reflecting the routes, duration and frequency of exposure. DNELs are derived for workers and the general population. The general population includes consumers and humans exposed via the environment. There are following annotations for each endpoint:
- Since the substance is not acutely toxic by oral route of exposure, no DNEL needs to be derived. This is based on a LD50dermal greater than 7500 mg/kg bw, a LD50oral > 2000 mg/kg bw and LC50inhalation greater 5 mg/L (as evident from the available studies/estimation).
- Acute DNELs for inhalation (systemic and local) are not necessary since there is no acute toxic hazard by inhalation.
- A qualitative approach in hazard assessment for eye and skin irritation/corrosion and skin sensitization is used because no quantitative dose descriptors are available on these endpoints.
- There is no animal data on repeated dermal or inhalation exposure. To cover this endpoint, data from an oral drinking water chronic toxicity study in rats on the suitable RA-substance MPS as most sensitive endpoint has been used to calculate the long-term DNELs.
- No DNELs for reprotoxic effects are derived because no evidence for toxicity to reproduction is available (which is directly attributable to the substance).
First of all, available dose descriptors were converted into a correct starting point to take into account differences in routes of exposure between experimental animals and humans and differences in human and animal exposure conditions. Consecutively, the assessment factors have been applied to the correct starting point to obtain the endpoint specific DNELs. Assessment factors (AFs) correct uncertainties and variability within and between species in the effect data.
The assessment factors are applied in accordance with R.8 ECHA guidance document.
Modification of the relevant dose descriptors to the correct starting point:
Bioavailability (absorption)
A dermal absorption rate of 10% is considered for the target substance as outlined in the subchapter “Basic Toxicokinetics”, based on the available physico-chemical and toxicological properties of the substance. The dermal absorption in rats and in humans is assumed to be the same since no experimentally determined values are available for dermal absorption of the target chemical in rats and in humans. In case of oral to inhalation extrapolation, 100% absorption is assumed for oral absorption and 50% absorption for inhalation is assumed.
Route-to-route extrapolation:
Oral-to-inhalation extrapolations are performed to assess long-term inhalation effects in humans, as well as oral-to-dermal extrapolations are conducted to assess long-term dermal effects in humans. This is due to the fact that only one oral study is available, because oral exposure in general is the most suitable administration route to assess systemic toxicity.
Exposure conditions:
No exposure time adaption are required. Rats were exposed chronically to the test substance once daily via drinking water, workers are exposed 8h daily (5 days/week). The dose descriptor (the NOAEL of ≥ 350 mg/kg bw) was not adjusted.
Respiratory volumes:
Differences in the respiratory volumes between experimental animals and humans were used when an oral rat NOAEL from the chronic study in rats was used to assess inhalation exposure in humans. 0.38 m³/kg/day is the standard respiratory volumes in rats during 8h exposure. 6.7 and 10 m³ are standard respiratory volumes for workers under normal conditions and by light activity, respectively.
Applying of assessment factors:
Interspecies differences:
No allometric scaling factor is applied in case of oral-to-inhalation extrapolation. For oral-to-dermal extrapolation, an allometric scaling factor of 4 is applied (default, rat to human).
An additional assessment factor of 2.5 is applied for remaining interspecies differences in toxicodynamics between rats and humans.
Intraspecies differences:
An assessment factor of 5 is applied for workers for all endpoints and for all exposure routes. The factor of 10 is used in the process of DNEL-calculation for general population due to the greater intra-species variations.
Extrapolation of duration:
No assessment factor is required as the available NOAEL was already derived from a chronic study.
Quality of whole data base:
An assessment factor for uncertainties in the quality of the data base is regarded to be 1, because no concern was indicated upon the quality of the provided data.
Issues related to dose response:
An assessment factor of 1 was used because there were no indications for deviation from the default value, as already the available NOAEL was derived applying scientifically valid considerations.
Remaining uncertainties:
An assessment factor of 1 was applied here because no remaining uncertainties were identified.
Calculation of endpoint-specific DNELs for workers
Long-term exposure - systemic effects (dermal)
The
oral NOAEL of 350 mg/kg bw was converted into the dermal NOAEL:
Dermal NOAEL = oral NOAEL x (ABS oral-rat/ABS dermal-human) = 350 mg/kg
bw x (100%/10%) = 3500 mg/kg bw.
DNEL = 3500 mg/kg bw/(1 x 1 x 4 x 2.5 x 5 x 1 x 1) = 70 mg/kg bw.
Assessment factors are: 1 – dose response (clear dose response), 1 – study duration (chronic study), 4 – interspecies, allometric scaling, 2.5 – remaining interspecies differences, 5 – intraspecies (workers), 1 – quality of data base, 1 – remaining uncertainties (none remaining).
Long-term exposure - systemic effects (inhalation)
The oral NOAEL of 350 mg/kg bw was converted into the inhalation NOAEC:
Inhalation NOAEC = oral NOAEL x (1/sRVrat) x (ABS oral-rat/ABS inhal-human) x (6.7 m³/10 m³) = 350 mg/kg bw x (1/0.38 m³/kg/day) x (100%/50%) x (6.7/10) = 1234.21 mg/m³
DNEL = 1234.21 mg/m³/(1 x 1 x 1 x 2.5 x 5 x 1 x 1) = 98.74 mg/m³.
Assessment factors are: 1 – dose response (clear dose response), 1 – study duration (chronic study), 1 – interspecies, no allometric scaling required for oral to inhalation exposure, 2.5 – remaining interspecies differences, 5 – intraspecies (workers), 1 – quality of data base, 1 – remaining uncertainties (none remaining).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.35 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 608.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Due to the low vapour pressure and its physical state (solid, no aerosols are formed during handling) of the test substance acute exposure hazard via inhalation is unlikely for humans and hence, repeated dose toxicity testing via the inhalation route was not done. Therefore a route-to-route extrapolation from an oral repeated dose study, as a worst case, is justified.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- No additional AF required as NOAEL is already derived from a chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling should be applied in case of oral-to-inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- default (database is of high quality)
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 35 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on dermal toxicity is available and required, so only oral toxicity data can be used.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- No additional AF required as NOAEL is already derived from a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for allometric scaling (rat to human) as given in ECHA guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- default (database is of high quality)
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- medium hazard (no threshold derived)
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:
- 3.5 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable - NOAEL from oral study
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- No additional AF required as NOAEL is already derived from a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for allometric scaling (rat to human) as given in ECHA guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- default (database is of high quality)
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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
The principles of the DNEL calculation for the general population are the same as already described for workers. However, there are additional considerations or deviations for:
Modification of the starting point:
Bioavailability (absorption)
The oral absorption in rats and in humans is assumed to be the same since no information for oral absorption for target chemical in rats and in humans is available.
Respiratory volumes:
No differences in the respiratory volumes under normal conditions and by light activity in humans were taken into account. A default respiratory volume of 1.15 m³/kg bw for rats was used to convert oral NOAEL into inhalation NOAEC.
Applying of assessment factors:
A higher assessment factor of 10 (instead of 5 for workers) for intraspecies variation/differences of human population was used.
Calculation of endpoint-specific DNEL for general population
Long-term exposure - systemic effects (oral)
The
oral NOAEL of 350 mg/kg bw was not modified for differences in
absorption by oral route since no substance- and route specific
information is available:
Oral NOAEL rat = oral NOAEL human = 350 mg/kg bw.
DNEL = 350 mg/kg bw/(1 x 1 x 4 x 2.5 x 10 x 1 x 1) = 3.5 mg/kg bw.
Assessment factors are:1 – dose response (clear dose response), 1 – study duration (chronic study), 4 – interspecies, allometric scaling, 2.5 – remaining interspecies differences, 10 – intraspecies (general population), 1 – quality of data base, 1 – remaining uncertainties (none remaining).
Long-term exposure - systemic effects (dermal)
The
oral NOAEL of 350 mg/kg bw was converted into the dermal NOAEL:
Dermal NOAEL = oral NOAEL x (ABS oral-rat/ABS dermal-human) = 350 mg/kg
bw x (100%/10%) = 3500 mg/kg bw.
DNEL = 3500 mg/kg bw/(1 x 1 x 4 x 2.5 x 10 x 1 x 1) = 35 mg/kg bw.
Assessment factors are: 1 – dose response (clear dose response), 1 – study duration (chronic study), 4 – interspecies, allometric scaling, 2.5 – remaining interspecies differences, 10 – intraspecies (general population), 1 – quality of data base, 1 – remaining uncertainties (none remaining).
Long-term exposure - systemic effects (inhalation)
The oral NOAEL of 350 mg/kg bw was converted into the inhalation NOAEC:
Corrected inhalation NOAEC = oral rat NOAEL x (1/1.15 m³/kg bw/day) x (ABS oral-rat/ABS inhal-human), where 1.15 m³/kg bw is standard respiratory volume of rats during 24 h, ABS is absorption (values are the same as described for workers).
Corrected Inhalation NOAEC = 350 mg/kg bw x (1/1.15 m³/kg/day) x (100%/50%) = 608.70mg/m³
DNEL = 608.70 mg/m³/(1 x 1 x 1 x 2.5 x 10 x 1 x 1) = 24.35 mg/m³.
Assessment factors are:1 – dose response (clear dose response), 1 – study duration (chronic study), 1 – interspecies, no allometric scaling required for oral to inhalation exposure, 2.5 – remaining interspecies differences, 10 – intraspecies (general population), 1 – quality of data base, 1 – remaining uncertainties (none remaining).
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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