Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-042-6 | CAS number: 553-54-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.6 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):
- 50
- Dose descriptor starting point:
- LOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The therapeutic dose of 40 mg/kg/day is considered to be the LOAEL in humans; ie the minimum dose to have an effect on the patient.
- AF for dose response relationship:
- 1
- Justification:
- Guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- Starting point based on chronic human LOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Starting point based on chronic human LOAEL
- AF for other interspecies differences:
- 5
- Justification:
- Starting point based on chronic human LOAEL; additional safety factor used
- AF for the quality of the whole database:
- 10
- Justification:
- Although based on public LOAEL data for humans, an additional factor 10 safety margin is recommended
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The therapeutic dose of 40 mg/kg/day is considered to be the LOAEL in humans; ie the minimum dose to have an effect on the patient.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for other interspecies differences:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for intraspecies differences:
- 5
- Justification:
- Starting point based on chronic human LOAEL; additional safety factor used
- AF for the quality of the whole database:
- 10
- Justification:
- Safety margin added
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.8 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The therapeutic dose of 40 mg/kg/day is considered to be the LOAEL in humans; ie the minimum dose to have an effect on the patient.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for intraspecies differences:
- 10
- Justification:
- For general population
- AF for the quality of the whole database:
- 10
- Justification:
- Additional safety factor added
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.8 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The therapeutic dose of 40 mg/kg/day is considered to be the LOAEL in humans; ie the minimum dose to have an effect on the patient.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for intraspecies differences:
- 10
- Justification:
- For general population
- AF for the quality of the whole database:
- 10
- Justification:
- Safety facrtor added
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The starting point is based on a published NOAEL in humans of 120 mg/kgday following oral administration.
- AF for intraspecies differences:
- 5
- Justification:
- Modified for general population
- AF for the quality of the whole database:
- 10
- Justification:
- Safety factor added
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
The therapeutic dose of 40 mg/kg/day Lithium is considered safe from the perspective to chronic toxicity, including CMR effects, but the psychological changes during therapy is clearly a 'toxic' response in its own right. The therapeutic dose is therefore considered to be the LOAEL level; ie the psychotic effect is 'adverse'.
Although there is no human data to confirm an effective safety margin, a nominal factor of 100 has been applied in considering a human NOEL level to the general population. The starting point used is therefore set based on the general population with a modifying factor of 0.5 to worker exposure.
There is no evidence of dermal or inhalation absorption of lithium and all therapeutic uses are by the oral route. A dose response ratio of 1 is used for inhalation and a modifying factor of 0.5 used for dermal.
These modifications have been applied to determine the key DNELs for chronic inhalation and dermal systemic toxicity.
In view of the absence of local toxic effects, short term DNELs have not been estimated; the therapeutic use requires multiple administration to maintain blood levels of lithium and for this reason, acute exposure levels for inhalation should not exceed the recommended chronic exposure.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
