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EC number: 208-914-3 | CAS number: 546-89-4
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Lithium acetate anhydrous and lithium
acetate dihydrate are both white, odourless solids with the formula
LiOOCCH3 and CH3COOLi * 2 H2O, respectively. Lithium acetate has a
molecular weight of 65.99 g/mol while its dihydrate has a molecular
weight of 102.02 g/mol. Both compounds are very soluble in water (>
10000 mg/L).
The substance completely dissociates in water forming lithium cation
(Li+) and the corresponding acetate anion (CH3COO- or acetic acid
C2H4O2). Therefore the log Pow of the anion (acetic acid) was evaluated
in a weight of evidence approach. Different literature sources report
the partition coefficient within the range of -0.31 to -0.17 for acetic
acid. The theoretical, calculated (EPIWIN) log Pow of acetic acid is
0.09.
The toxicokinetic assessment of lithium acetate focuses mainly on
lithium as it is the moiety with the pharmacological activity. Further,
the acetate anion is the conjugated base of acetic acid, which is used
in the food industry as a preservative against bacteria and fungi. As
acetic acid is considered harmless, no acceptable daily intake (ADI)
limit is set (FAO/WHO Expert Committee on Food Additives, 2000).
Estimations of the daily intake of acetic acid vary from about 1 g to
2.1 g/day for subjects older than 2 years. No adverse health effects are
reported at these intakes (SCOEL, 2012).
Lithium has been neither known as an essential element for life nor has
known biological use but according to various reports there is growing
evidence that lithium may be an essential mineral in the human diet. The
average daily lithium intake of 70 kg adult (in the U.S.A.) is between
0.65 and 3.1 mg/day and in some lithium-rich places like Chile, the
total lithium intake may reach 10 mg/day without evidence of adverse
effects to the local population. Major dietary sources of lithium are
grains and vegetables, dairy products and meat. A recommended daily
intake (RDA) of 1.0 mg lithium/day for 70 kg adult was proposed,
corresponding to 14.3 µg/kg bw. Intake of lithium can occur as part of a
psychiatric therapy in the treatment of bipolar affective disorders as
lithium ion (Li+) (administered as any of several lithium salts) has
proved to be useful as a mood-stabilizing drug.
Since lithium has been used as a psychiatric drug for almost half a
century, there are many numbers of publications on lithium
pharmacokinetics and toxicity in humans.
Dermal absorption
The stratum corneum provides its greatest barrier function against
hydrophilic compounds, whereas the viable epidermis is most resistant to
highly lipophilic compounds. Based on the hydrophilic character of
lithium acetate and the barrier function of the stratum corneum against
salts, dermal absorption is expected to be very poor. It is supported by
an acute dermal toxicity study with lithium acetate dihydrate that
revealed a LD50 value >2000 mg/kg bw without any local or systemic
effects. The assumption that absorption is negligible is further
confirmed by the negative results of an EPISKIN assay (OECD 439) with
lithium acetate anhydrous and a Corrositex assay with lithium acetate
dihydrate, respectively. Further, no sensitization was observed in a
sensitization studies with the read-across substances lithium chloride
and lithium carbonate. Additionally, acetic acid is an important
industrial chemical that is also used in food industry as acidity
regulator (E260). Its harmonised classification and labelling listed in
Annex VI of Regulation (EU) No 1272/2008 does not include skin
sensitising properties. Based on the results of the read across
substances it is concluded, that lithium acetate is not skin sensitizing.
Resorption after oral uptake:
Upon oral uptake, lithium acetate will reach the stomach in form of
lithium ions and acetate ions. Lithium- and acetate ions will be readily
and almost completely absorbed from the gastrointestinal tract due to
their low molecular weight (< 500 g/mol). Additionally, the low log Pow
of both ions favors them for absorption by passive diffusion and
therefore they can cross lipophilic membranes. They are also small and
water soluble enough to be carried through the epithelial barrier by the
bulk passage of water. In a study with lithium acetate an LD0 of 1500
mg/kg bw was determined. Based on this result the substance in
classified as cat. 4 H302.
Resorption after inhalation:
The vapour pressure of lithium acetate is negligible (Modified Gain
method: 2.59E-006 Pa at 25 °C) and therefore exposure to vapour is
toxicologically not relevant. If lithium ions reach the lung resorption
after inhalation is assumed to be low due to the very low log Pow. Thus,
upon inhalation, the bioavailability of lithium acetate is expected to
be low.
Distribution, Metabolism and Excretion
Lithium:
Lithium does not bind to protein and as a small cation it is quickly
distributed throughout the body water both intra- and extracellularly,
replacing normal cations (as K+, Na+). Lithium ion effects in the cell
level are presumed to be related to interferences with processes that
involve these ions such as renal tubular transport and ion channels
involved in neurotransmission. Lithium has a large volume of
distribution of 0.6-0.9 L/kg (for a 70 kg human a 42 L of volume of
distribution). Because of its large volume of distribution, lithium
shifts into the intracellular compartment of cells. With long-term use,
the intracellular concentration of lithium increases, which thereby
results in increased total body lithium load. The intracellular
concentration is not reflected by the plasma level, which measures only
the extracellular fluid concentration. Organ distribution is not
uniform: Lithium is rapidly taken up by the kidney (there is obviously a
clear interaction between lithium and sodium excretion/retention
altering the electrolyte balance in humans). Penetration is slower into
the liver, bone and muscle. Its passage across the blood-brain barrier
is slow and equilibration of the CSF lithium level reaches only
approximately half the plasma concentration.
The primary route of excretion is through the kidneys. Lithium is
filtered by the glumeruli and 80 % of the filtered lithium is reabsorbed
in the tubules, probably by the same mechanism of sodium reabsorption.
Lithium is excreted primarily in urine with less than1 % being
eliminated with the feces.
The renal clearance of lithium is proportional to its plasma
concentration. The excretion of lithium ions is considered to be fast.
About 50 % of a single dose of lithium is excreted in 24 hours and about
90 % in 48 hours. However, trace amounts can still be found 1 to 2 weeks
after the ingestion of a single lithium dose. A single oral dose of
lithium ion is excreted almost unchanged through the kidneys. A low salt
intake resulting in low tubular concentration of sodium will increase
lithium reabsorption and might result in retention and intoxication.
Renal lithium clearance is under ordinary circumstances, remarkably
constant in the same individual but decreases with age and also when
sodium intake is lowered.
Due to the fast excretion bioaccumulation is not to be assumed. Lithium
is not metabolised to any appreciable extent in the human body. In
conclusion, lithium in human body is quickly distributed and unchanged
excreted. Bioaccumulation can be excluded.
Acetate ion/Acetic acid:
The acetate ion (the anion of acetic acid) is a normally occurring
metabolite in catabolism or in anabolic synthesis (e.g. in formation of
glycogen, cholesterol synthesis, degradation of fatty acids, and
acetylation of amines). The estimated plasma level of the acetate ion in
the human body is about 50-60 µmol/L (3.0-3.6 mg/L) and 116 µmol/L (7
mg/L) in cerebrospinal fluid. Daily turnover of the acetate ion in
humans is estimated to be about 7.5 µmol/kg/min (45 g/day; SCOL, 2012).
Via the citric acid cycle, acetate is rapidly metabolised to carbon
dioxide, which will be eliminated from the body, predominantly via the
exhaled air and in smaller quantities also via urine and faeces. Acetic
acid can also be used as a building block e.g. in the biosynthesis of
fatty acids (efsa, 2011)
References:
ECHA (2017) Guidance on information
requirements and chemical safety assessment, Chapter R.7c: Endpoint
specific guidance.
European Food Safety Authority
(efsa, 2011): Scientific Opinion on Flavoring Group Evaluation 309
(FGE.309): Sodium Diacetate. EFSA Panel on Food Contact Materials,
Enzymes, Flavourings and Processing Aids. EFSA Journal, 9(7):2163.
Scientific Committee on Occupational Exposure (SCOEL, 2012):
Recommendation from the Scientific Committee on Occupational Exposure
Limits for acetic acid. SCOEL/SUM/98, June 2012.
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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