Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 485-110-0 | CAS number: 53535-81-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Expert Statement
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: Expert Statement
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Expert statement
Test material
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- no test animals, Expert statement
Administration / exposure
- Details on exposure:
- no test animals, Expert statement
- Duration and frequency of treatment / exposure:
- no test animals, Expert statement
Doses / concentrations
- Remarks:
- Doses / Concentrations:
no test animals, Expert statement
- No. of animals per sex per dose / concentration:
- no test animals, Expert statement
- Positive control reference chemical:
- no test animals, Expert statement
- Details on study design:
- no test animals, Expert statement
- Details on dosing and sampling:
- no test animals, Expert statement
- Statistics:
- no test animals, Expert statement
Results and discussion
- Preliminary studies:
- not applicable
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- LiOH:
Following oral uptake the Li+ cation and OH- anion dissociate in the stomach. Lithium is rapidly absorbed in the gastrointestinal tract. Blood levels peak after single doses between two to four hours and full absorption occurs in about 8 hours.
Tert-amyl alcohol:
The most likely route of exposures are via the oral route, followed by inhalation. Uptake of tert-amyl alcohol or the parent compound via the skin can be practically excluded, based on physical chemical properties. Following oral uptake, tert-amyl alcohol is partially absorbed in the GI-tract. Exposure via inhalation may lead to uptake via the lungs, however, absorption is likely to be lower than via the oral route. - Details on distribution in tissues:
- LiOH:
Lithium is not protein bound and distributes throughout the body and then gradually accumulates in various tissues.
Tert-amyl alcohol:
Following uptake, distribution in the body is likely to be limited, due to the compounds low water solubility.
- Details on excretion:
- LiOH:
Approximately 95% of a single dose of Li+ is eliminated in the urine. From one- to two-thirds of an acute dose is excreted during a 6- to 12-hour initial phase of excretion, followed by slow excretion over the next 10 to 14 days.
Ter-amyl alcohol:
Substantial fractions of tert-amyl alcohol are excreted in urine and respired in air. The fraction of the tertiary alcohols excreted unchanged is substantially higher than those of the primary or secondary alcohols. The fraction of tert-amyl alcohol becoming bioavailable is relatively small.
Metabolite characterisation studies
- Details on metabolites:
- Metabolites indentified: not measured.
LiOH:
Lithium is not protein bound and not metabolised.
Ter-amyl alcohol:
Several phase I metabolic reactions, including reduction and hydrolysis reactions, catalysed by cytochrome P-450-dependent monooxygenase enzymes may occur. Parent compound and metabolites formed in phase I metabolic reactions may be rendered more polar by phase II metabolism in subsequent steps. Finally, remaining amounts of the parent compound and formed metabolites are expected to be excreted in urine or bile. Following oral administration of tert-amyl alcohol to rabbits, small amounts of conjugated glucuronic acid were found in the urine. However, dogs excreted no glucuronic acid following administration of the tertiary alcohol.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: no bioaccumulation based on study results.
- Executive summary:
LTA disintegrates as soon as in contact with water. The hydrolysis reaction is spontaneous and takes place instantaneous. Thus, the toxicokinetic profile of LTA is determined by the compound's hydrolysis products LiOH and tert-amyl alcohol, respectively.
Both, LiOH and tert-amyl alcohol are of relatively low acute toxicity. For LiOH the subacute oral LOAEL was determined in rats at 9.1 mg/kg bw/day and the inhalation LOAEL at 8.0 mg/m3/4h. For tert-amyl alcohol the subchronic inhalation NOEL in mice was determined at 1000 ppm, in rats at 225 ppm and in dogs a subchronic inhalation NOAEL was estimated at 225 ppm. Subacute dermal administration of tert-amyl alcohol to rabbits revealed a NOAEL of 344 mg/kg bw/day.
Local irritation may occur, due to the alkaline properties inherent to the hydroxide anion in LiOH. Tert-amyl alcohol also revealed skin and eye irritation. Both hydrolysis products of LTA did not show sensitisation potential.
Both the hydrolysis products and the parent compound did not show genotoxic potential. Both, LiOH and tert-amyl alcohol were not mutagenic when tested in an Ames test. The parent compound LTA was shown to be not mutagenic and not clastogenic in an Ames test and an in vitro chromosome aberration test, respectively.
Of a single dose of Li+ 95 % are eliminated in the urine. 80 % of the filtered Li+ is reabsorbed by the proximal renal tubules and clearance of Li+by the kidney is about 20 % of that for creatinine, ranging between 15 and 30 ml/minute. Less than 1% of ingested Li+ leaves the human body in the faeces, and 4 % to 5 % is secreted in sweat.
For tert-amyl alcohol bioaccumulation is not likely to occur, based on structure and associated physical-chemical characteristics (logBCF = 0.5). A large fraction is excreted unchanged via urine and respiration. Once bioavailable, the substance or its metabolites are expected to be little distributed throughout the body fluids, but rapidly excreted via urine (non-conjugated forms) or via faces (high molecular weight conjugated forms). Formation of toxic tert-amyl alcohol metabolites is unlikely. No indication for either compound to bioaccumulate was found.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies