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Diss Factsheets
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EC number: 233-820-4 | CAS number: 10377-48-7
- 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:
- 10 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):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 33.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value was initially used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable according to ECHA REACH Guidance document R8, 2012
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, please refer to the discussion
- AF for the quality of the whole database:
- 1
- Justification:
- Please refer to the discussion
- AF for remaining uncertainties:
- 1
- Justification:
- Please refer to the discussion
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:
- 95 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):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 95 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, please refer to the discussion
- AF for the quality of the whole database:
- 1
- Justification:
- Please refer to the discussion
- AF for remaining uncertainties:
- 1
- Justification:
- Please refer to the discussion
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNEL derivation for each of the relevant endpoints was based on the most conservative dose descriptors obtained. Assessment factors were assigned accordingly. Thus, the DNELs represent worst-case scenarios.
DNEL long-term inhalation, systemic
According to ECHA guidance document CSA: R8, 2012, for dust as in the case with lithium sulfate and lithium sulfate monohydrate, the general dust limit should be applied if the derived DNEL for inhalation is above the general dust limit (10 mg/m³).
As the calculated DNEL long-term inhalation for lithium sulfate and lithium sulfate monohydrate was determined to be 33.27 mg/m³ and 38.72 mg/m³, respectively (see below *), the DNEL considered for risk characterisation is the general dust limit of 10 mg/m³.
* An inhalation NOAEC was derived by route-to-route extrapolation (ECHA CSR R8, 2012) from the lithium NOAEL long-term oral (human) value of 1.2 mg Li/kg bw/day, corresponding to 84 mg Li/person/day (70 kg/person x 1.2 mg Li/kg bw/day), as lithium is the toxicological relevant component of lithium sulfate (obtained from human data, long-term (chronic) treatment of bipolar disorder with lithium carbonate, see IUCLID section 7.5). The oral, long-term (human) NOAEL of 1.2 mg Li/kg bw/day was converted to an inhalation NOAEC (human), assuming, 70 kg body weight for worker, 100 % absorption via the lung, 50 % absorption via the oral route and a daily exposure period of 8 hours during light activity (corresponding to breathing volume of 10 m³/day). Accordingly, a NOAEC of 4.2 mg Li/m³ equivalent to 33.26 mg Li2SO4/m³ and 38.71 mg Li2SO4*H2O/m³ was calculated.
NOAEC (worker) inhalation = 84 mg Li/person/ day * (1 / 10m³/person/day(8h)) * (50 % Abs. / 100 % abs.) = 4.2 mg Li/m³
= 33.26 mg Li2SO4/m³
= 38.71 mg Li2SO4*H2O/m³.
An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations (being acceptable to humans, which are physically fit, but also being applicable to all sub-populations, in conclusion being applicable to worker and general population).
The resulting worker DNEL long-term inhalation is 33.26 mg Li2SO4/m³/day and 38.71 mg Li2SO4*H2O/m³/day
(33.26 mg/m³/day : 1 (AFs); 38.71 mg/m³/day : 1 (AFs)).
DNEL long-term dermal, systemic
The NOAEL long-term dermal of 95.0 mg Li2SO4/kg bw/day and 110.6 mg Li2SO4*H2O/kg bw/day were calculated from the NOAEL long-term oral of 9.50 mg Li2SO4/kg bw/day and 11.06 mg Li2SO4*H2O/kg bw/day considering a conservative 10 % absorption through the skin (ECHA document R.7C, 2012, 7.12).
NOAEL (Li2SO4) long-term dermal = 9.5 mg/kg bw/day x 100% : 10% = 95 mg Li2SO4/kg bw/day;
NOAEL (Li2SO4*H2O) long-term dermal = 11.06 mg/kg bw/day x 100% : 10% = 110.6 mg Li2SO4*H2O/kg bw/day.
The NOAEL long-term oral and thus the NOAEL long-term dermal are based on lithium toxicity as lithium is the toxicological relevant component of lithium sulfate. An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from very reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations (being acceptable to humans, which are physically fit but also being applicable to all sub-populations) and therefore applicable for worker and general population.
The resulting
DNEL long-term dermal (Li2SO4) is 95.0 mg Li2SO4/kg bw/day : 1 (AFs) = 95.0 mg Li2SO4/kg bw/day and
DNEL long-term dermal (Li2SO4*H2O) is 110.6 mg Li2SO4*H2O/kg bw/day : 1 (AFs) = 110.6 mg Li2SO4*H2O/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 16.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, please refer to the discussion
- AF for the quality of the whole database:
- 1
- Justification:
- Please refer to the discussion
- AF for remaining uncertainties:
- 1
- Justification:
- Please refer to the discussion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 95 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):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 95 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Calculations based on worst case. Performance of the study was waived according to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, section 8.6.1 (see IUCLID section 7.5.3).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, please refer to the discussion
- AF for the quality of the whole database:
- 1
- Justification:
- Please refer to the discussion
- AF for remaining uncertainties:
- 1
- Justification:
- Please refer to the discussion
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.5 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):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 9.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation required.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value used for calculations
- AF for differences in duration of exposure:
- 1
- Justification:
- Recommended AF (for chronic exposure) ECHA REACH Guidance document R8, 2012
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, derived from human data
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable, derived from human data
- AF for intraspecies differences:
- 1
- Justification:
- Not applicable, please refer to the discussion
- AF for the quality of the whole database:
- 1
- Justification:
- Please refer to the discussion
- AF for remaining uncertainties:
- 1
- Justification:
- Please refer to the discussion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 28.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNEL derivation for each of the relevant endpoints was based on the most conservative dose descriptors obtained. Assessment factors were assigned accordingly. Thus, the DNELs represent worst-case scenarios.
DNEL long-term inhalation, systemic effects
According to ECHA guidance document CSA: R8, 2012, for dust if the derived DNEL for inhalation is above the general dust limit (10 mg/m³), then the general dust limit should be applied. As the calculated DNEL long-term inhalation for lithium sulfate and lithium sulfate monohydrate was determined to be 16.63 mg/m³ and 19.36 mg/m³, respectively (see below *), the DNEL considered for risk characterisation is the general dust limit of 10 mg/m³.
* An inhalation NOAEC was derived by route-to-route extrapolation (ECHA CSR R8, 2012) from the lithium NOAEL long-term oral (human) value of 1.2 mg Li/kg bw/day, corresponding to 84 mg Li/person/day (60 kg/person x 1.2 mg Li/kg bw/day), as lithium is the toxicological relevant component of lithium sulfate (obtained from human data, long-term (chronic) treatment of bipolar disorder with lithium carbonate, see IUCLID section 7.5). The oral, long-term (human) NOAEL of 1.2 mg Li/kg bw/day was converted to an inhalation NOAEC (human), assuming, 60 kg body weight for general population, 100 % absorption via the lung, 50 % absorption via the oral route and a daily exposure period of 24 hours (corresponding to breathing volume of 20 m³/day). Accordingly, a NOAEC of 2.1 mg Li/m³ equivalent to 16.63 mg Li2SO4 /m³ and 19.36 mg Li2SO4*H2O/m³ was calculated.
NOAEC (general population) inhalation = 84 mg Li/person/day * (1 / 20 m³/person/day(24h)) * (50 % Abs./ 100 % Abs.) = 2.1 mg Li/m³
= 16.63 mg Li2SO4/m³
= 19.36 mg Li2SO4*H2O/m³.
An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations (being acceptable to humans, which are physically fit but also being applicable to all sub-populations), being applicable for general population. The resulting DNEL long-term inhalation (general population) is 16.63 mg Li2SO4/m³ and 19.36 mg Li2SO4/m³ (16.63 mg Li2SO4/m³ : 1 (AFs), 19.36 mg Li2SO4*H2O/m³ : 1 (AFs)).
DNEL long-term dermal, systemic
The NOAEL long-term dermal of 95.0 mg Li2SO4/kg bw/day and 110.6 mg Li2SO4*H2O/kg bw/day were calculated from the NOAEL long-term oral of 9.50 mg Li2SO4/kg bw/day and 11.06 mg Li2SO4*H2O/kg bw/day considering a conservative 10 % absorption through the skin (ECHA document R.7C, 2012, 7.12).
NOAEL (Li2SO4) long-term dermal = 9.5 mg/kg bw/day x 100% : 10% = 95 mg Li2SO4/kg bw/day;
NOAEL (Li2SO4*H2O) long-term dermal = 11.06 mg/kg bw/day x 100% : 10% = 110.6 mg Li2SO4*H2O/kg bw/day.
The NOAEL long-term oral and thus the NOAEL long-term dermal are based on lithium toxicity as lithium is the toxicological relevant component of lithium sulfate. An AF for exposure duration was not applicable, as data covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from very reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations being also acceptable to general population.
The resulting DNEL long-term dermal (Li2SO4) = 95.0 mg Li2SO4/kg bw/day : 1 (AFs) = 95.0 mg Li2SO4/kg bw/day and
DNEL long-term dermal (Li2SO4*H2O) = 110.6 mg Li2SO4*H2O/kg bw/day : 1 (AFs) = 110.6 mg Li2SO4*H2O/kg bw/day.
DNEL lomg-term oral, systemic effects
The toxicological relevant component of lithium sulfate is lithium. Thus, the NOAEL long-term oral was calculated to be 9.50 mg Li2SO4/kg bw/day and 11.06 mg Li2SO4*H2O/kg bw/day, based on lithium NOAEL long-term oral of 1.2 mg Li/kg bw/day (obtained from human data on long-term (chronic) treatment of bipolar disorder with lithium carbonate, see IUCLID section 7.5). For lithium sulfate and lithium sulfate monohydrate DNEL long-term oral derivation, an AF for exposure duration was not applicable as data available covered long-term / chronic exposure. Interspecies AFs were not applicable as the relevant NOAEL was derived from reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on therapeutic concentrations being applicable to general population.
The resulting DNEL general population long-term oral is 9.50 mg Li2SO4/kg bw/day and 11.06 mg Li2SO4*H2O/kg bw/day
(9.50 mg Li2SO4/kg bw/day : 1 (AFs), 11.06 mg Li2SO4*H2O/kg bw/day : 1 (AFs)).
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