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Diss Factsheets
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EC number: 232-218-9 | CAS number: 7790-69-4
- 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:
- 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:
- 14.4 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 1907/2006/EC Annex VIII section 8.6.1 (see 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, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
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:
- 41.1 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:
- 41.1 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 1907/2006/EC Annex VIII section 8.6.1 (see section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value was 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, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
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 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 was determined to be 14.40 mg LiNO3/m³ (see below *), the DNEL considered for risk characterisation is the general dust limit (10 mg/m³).
* For DNEL long-term inhalation derivation, a NOAEC value was calculated by route-to-route extrapolation (ECHA CSA R8, 2012) from the NOAEL long-term oral (human) value. The NOAEL long-term oral (human) value of lithium nitrate was based on the ADI (Acceptable Daily Intake) value of nitrate (3.7 mg nitrate/kg bw/day) being the toxicological limiting value for lithium nitrate (see IUCLID section 7.5). Thus, the NOAEC (human) calculation for lithium nitrate was based on the NOAEL (human) long-term value of nitrate (3.7 mg nitrate/kg bw/day) corresponding to 259 mg nitrate/person/day (70 kg/person x 3.7 mg Br-/kg bw/day). This value 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 (8 h). Accordingly, a NOAEC of 12.95 mg nitrate/ m³ was calculated which is equivalent to 14.40 mg lithium nitrate/m³.
NOAEC (worker)inhalation = 259 mg nitrate/person/day x (1 / 10 m³/person/day(8h)) x (50 % Abs. / 100 % Abs.) = 12.95 mg nitrate/m³ = 14.40 mg lithium nitrate/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 very reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on a toxicological value (ADI of nitrate) which is relevant for worker and general population including sub-populations. The resulting worker DNEL long-term inhalation = 14.40 mg LiNO3/m³ : 1 (AFs) = 14.40 mg LiNO3/m³.
DNEL long-term dermal, systemic effects
The NOAEL long-term dermal of 41.1 mg (LiNO3)/kg bw/day was calculated from the NOAEL long-term oral of 4.11 mg (LiNO3)/kg bw/day considering a conservative 10 % absorption through the skin (ECHA document R.7c, 2012, 7.12).
NOAEL long-term dermal = 4.11 mg/kg bw/day x 100 : 10 = 41.1 mg/kg bw/day.
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 a toxicological value (ADI of nitrate) which is relevant for workers and general population.
The resulting DNEL long-term dermal = 41.1 mg LiNO3/ kg bw/day : 1 (AFs) = 41.1 mg LiNO3/ kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.12 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:
- 6.12 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 1907/2006/EC Annex VIII section 8.6.1 (see 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, 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, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
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:
- 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:
- 41.1 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:
- 41.1 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 1907/2006/EC Annex VIII section 8.6.1 (see section 7.5.2).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (human, oral) value was 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, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- see below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
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:
- 4.11 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:
- 4.11 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 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, see below in "justification and comments"
- AF for the quality of the whole database:
- 1
- Justification:
- See below in "justification and comments"
- AF for remaining uncertainties:
- 1
- Justification:
- See below in "justification and comments"
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 12.33 mg/kg bw/day
- Most sensitive endpoint:
- acute 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
For DNEL long-term inhalation derivation, a NOAEC value was calculated by route-to-route extrapolation (ECHA CSA R8, 2012) from the NOAEL long-term oral (human) value. The NOAEL long-term oral (human) value of lithium nitrate was based on the ADI (Acceptable Daily Intake) value of nitrate (3.7 mg nitrate/kg bw/day) being the toxicological limiting value for lithium nitrate (see IUCLID section 7.5). Thus, the NOAEC (human) calculation for lithium nitrate was based on the NOAEL (human) long-term value of nitrate (3.7 mg nitrate/kg bw/day) corresponding to 222 mg nitrate/person/day (60 kg/person x 3.7 mg nitrate/kg bw/day). This value 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 during light activity (corresponding to breathing volume of 20 m³/day (8 h). Accordingly, a NOAEC of 5.55 mg nitrate/ m³ was calculated which is equivalent to 6.12 mg lithium nitrate/m³.
NOAEC (general population)inhalation = 222 mg nitrate/person/day x (1 / 20 m³/person/day(24h)) x (50 % Abs. / 100 % Abs.) = 5.55 mg nitrate/m³ = 6.12 mg lithium nitrate/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 very reliable and relevant high quality human data. Intraspecies differences were considered not applicable as the NOAEL was based on a toxicological value (ADI of nitrate) which is relevant for worker and general population including sub-populations. The resulting general population DNEL long-term inhalation = 6.12 mg LiNO3/m³ : 1 (AFs) = 6.12 mg LiNO3/m³.
DNEL long-term dermal, systemic effects
The NOAEL long-term dermal of 41.1 mg (LiNO3)/kg bw/day was calculated from the NOAEL long-term oral of 4.11 mg (LiNO3)/kg bw/day considering a conservative 10 % absorption through the skin (ECHA document R.7c, 2012, 7.12).
NOAEL long-term dermal = 4.11 mg/kg bw/day x 100 : 10 = 41.1 mg/kg bw/day.
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 a toxicological value (ADI of nitrate) which is relevant for workers and general population.
The resulting DNEL long-term dermal = 41.1 mg LiNO3/ kg bw/day : 1 (AFs) = 41.1 mg LiNO3/ kg bw/day.
DNEL long-term oral, systemic effects
For calculation of the NOAEL long-term oral of lithium nitrate the following (human) data was available (see IUCLID section 7. 5): The ADI value of nitrate (3.7 mg nitrate/kg bw/day) and the NOAEL/DNEL of lithium (1.2 mg lithium/kg bw/day). The calculated NOAEL oral of lithium nitrate (4.11 mg lithium nitrate/kg bw/day) based on the ADI of nitrate is smaller than the calculated NOAEL of lithium nitrate (11.92 mg lithium nitrate/kg bw/day) based on the NOAEL/ DNEL of lithium. Thus, the determined NOAEL oral of lithium nitrate is 4.11 mg lithium nitrate/kg bw/day based on the ADI value of nitrate being the toxicological limiting value for lithium nitrate.
As the NOAEL long-term oral of lithium nitrate is based on the ADI of nitrate (comparable to DNEL), it can be assumed that the AFs were already included. Thus, no AFs were considered (AF = 1). It can also be explained and detailed as following: 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 a toxicological value (ADI nitrate) which is relevant for general population and worker. DNEL (general population) long-term oral = 4.11 mg lithium nitrate/kg bw/day : 1 (AFs) = 4.11 mg lithium nitrate/kg bw/day.
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