Registration Dossier

Environmental fate & pathways

Bioaccumulation: terrestrial

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Administrative data

Endpoint:
bioaccumulation: terrestrial
Type of information:
other: Due to its hydrolytic instability, the registered substance will not be present in surface waters. Evaluation of bioaccumulation potential must therefore be based on its hydrolysis products. This information source reports lithium bioaccumulation data.
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert review of available information on interactions of lithium and lithium salts with biological systems, published by the Swedish National Institute for Working Life

Data source

Reference
Reference Type:
secondary source
Title:
Lithium and lithium compounds
Author:
Lagerkvist B.J. and Lindell B.
Year:
2002
Bibliographic source:
The Nordic Expert Group for Criteria Documentation of Health Risks from Chemicals, Volume 131.

Materials and methods

Principles of method if other than guideline:
Expert review of absorption and excretion of lithium in experimental animals and man.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Lithium (LiF, dissociating to give Li+ ions) is a hydrolysis product of the reaction of LiPF6 with water

Test organisms

Details on test organisms:
Rats and humans

Results and discussion

Kinetic parameters:
Half-life for lithium elimination from serum after one or a few doses has been reported as 11 -12h in adult rats, 2 -6h in man.

Any other information on results incl. tables

In man, >95% of a single Li+ dose has been reported to be eliminated without change, via the kidneys. Elimination via sweat and faeces accounts for <1% and 4 -5% respectively. The urinary elimination is biphasic: up to 66% of the dose is excreted within 6 -12h, the rest being excreted during the following 10 -14 days.

Elderly patients on chronic lithium medication may eliminate lithium more slowly (serum/plasma half-life for elimination up to 58h).

With repeated human administration, a steady-state balancing absorption and excretion is achieved after 5 -6 days.

Applicant's summary and conclusion

Conclusions:
Information from animal studies, human trials and human repeat-dose therapy all suggest that lithium is not extensively accumulated within the body