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Diss Factsheets
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EC number: 214-317-9 | CAS number: 1120-71-4
- 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:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.32 µg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25 000
- Dose descriptor starting point:
- T25
- Value:
- 4.48 mg/kg bw/day
- Modified dose descriptor starting point:
- T25
- Value:
- 7.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of specific absorption data following oral, dermal or inhalation exposure, the acute toxicity data can be used to establish a factor for the oral-to-inhalation route extrapolation.
The inhalation LC50 in the rat after a 6-hour exposure is approximately 1.7 mg/L (OTS, 1992). Taking into account a rat breathing volume of 0.29 m³/kg bw and assuming 100% absorption the corresponding systemic dose is 490 mg/kg bw. In comparison, oral LD50 values ranging between 100 and 350 mg/kg bw have been reported for the rat (OTS, 1992; MAK, 1985; Druckrey et al., 1970), indicating that inhalation absorption will not be higher than oral absorption. Thus, the factor of 1 for oral-to-inhalation extrapolation is justified.
Taking into account the T25 (oral, workplace) of 4.48 mg/kg bw/d, the 8-h standard respiratory volume of 0.38 m³/kg bw for the rat, the adjustment of the respiratory volume for light activity of 6.7 m³/10 m³ and the oral-to-inhalation route extrapolation factor of 1 the T25 (inhalation, workplace) can be calculated as:
T25 (inhalation, workplace) = 4.48 mg/kg bw/d / 0.38 m³/kg bw x 1 x 6.7 m³/10 m³ = 7.9 mg/m³
- AF for dose response relationship:
- 25 000
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, the dose descriptor T25, has an increasing order incorporated uncertainty in its estimate and therefore, there is no separate assessment factor to account for this. Another related issue concerning the dose response that is relevant specifically for non-threshold effects is high to low dose extrapolation. This is covered with a default value for the worker of 25000.
- AF for differences in duration of exposure:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, no assessment factor has to be applied for this extrapolation step for non-threshold effects.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012) no interspecies assessment factor for the inhalation route have to apply.
- AF for other interspecies differences:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, no assessment factor has to be applied for non-threshold effects.
- AF for intraspecies differences:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, no assessment factor has to be applied for non-threshold effects.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA standard value for good/standard quality of the database.
- AF for remaining uncertainties:
- 1
- Justification:
- No further remaining differences are available.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.1 µg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100 000
- Dose descriptor starting point:
- T25
- Value:
- 4.48 mg/kg bw/day
- Modified dose descriptor starting point:
- T25
- Value:
- 9.96 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In the absence of specific absorption data following oral, dermal or inhalation exposure, the acute toxicity data can be used to establish a factor for the oral-to-dermal route extrapolation.
The only species where both dermal and oral acute toxicity data are available is the mouse. Whereas the oral LD50 is 400 mg/kg bw (OTS, 1992), the dermal LD50 is > 830 mg/kg bw (830 mg/kg bw caused 15% death; Doak et al., 1972). This data indicates that dermal absorption will be more than 2-fold lower than oral absorption, justifying a factor of 0.5 for oral-to-dermal extrapolation.
Taking into account the T25 (oral, workplace) of 4.48 mg/kg bw/d and the oral-to-dermal route extrapolation factor of 0.5 the T25 (dermal, workplace) can be calculated as:
T25 (dermal, workplace) = 4.48 mg/kg bw/d / 0.5 = 9.96 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, the dose descriptor T25, has an increasing order incorporated uncertainty in its estimate and therefore, there is no separate assessment factor to account for this. Another related issue concerning the dose response that is relevant specifically for non-threshold effects is high to low dose extrapolation. This is covered with a default value for the worker of 25000.
- AF for differences in duration of exposure:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, no assessment factor has to be applied for this extrapolation step for non-threshold effects.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default value for the rat.
- AF for other interspecies differences:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, no assessment factor has to be applied for non-threshold effects.
- AF for intraspecies differences:
- 1
- Justification:
- According to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, 2012), linearised approach for DMEL calculation, no assessment factor has to be applied for non-threshold effects.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA standard value for good/standard quality of the database.
- AF for remaining uncertainties:
- 1
- Justification:
- No further remaining differences are available.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
1,3-propanesultone is a highly reactive alkylating agent. As its hazard potential is dominated by the carcinogenic potency, the establishment of DNELs is not needed and only DMELs are relevant.
Acute /short-term exposure – systemic and local effects
Due to its carcinogenic potency 1,3-propanesultone is manufactured and used under rigorous risk management measures which prevent the occurrence of peak exposures. Therefore, the derivation of acute/short term DMELs for local and systemic effects is not needed. This is in agreement with the “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012).
Long term exposure - systemic and local effects
A dermal T25 value of 9.96 mg/kg bw/d has been established for 1,3-propanesultone. Taking into account an interspecies assessment factor of 4 for rat-to-human extrapolation and the high-to-low-dose extrapolation factor of 25000 the DMEL can be calculated as follows:
DMEL(long term dermal exposure, systemic effects) = 9.96 mg/kg bw/d / 4 / 25000 = 0.0001 mg/kg bw/d or 0.1 µg/kg bw/d.
For inhalation exposure a T25 value of 7.9 mg/m³ has been derived. As for the inhalation route no interspecies assessment factors applies, only the high-to-low-dose extrapolation factor of 25000 has to be taken into account to calculate the DMEL:
DMEL(long term inhalation exposure, systemic effects) = 7.9 mg/m³ / 25000 = 0.00032 mg/m³ or 0.32 µg/m³
In the chronic skin painting study in mice (Doak et al., 1976) the incidence of local and systemic tumors were similar, i.e. 59% of the treated mice developed local tumors and 51% systemic tumors. Therefore, the local effects are covered by the DMEL established for long term exposure - systemic effects and a derivation of a DMEL for long term exposure - local effects is not needed.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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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