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EC number: 600-039-9 | CAS number: 10023-48-0
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Preliminary findings of high-dose Thiamine in Dementia of Alzheimer´s Type
- Author:
- Meador K. et al.
- Year:
- 1 993
- Bibliographic source:
- J Geriatr Psychiatry Neurol. 6(4):222-229
Materials and methods
- Endpoint addressed:
- repeated dose toxicity: oral
- Principles of method if other than guideline:
- The test substance was administered orally at 3 g/day and at 4 - 8 g/day, respectively, in patients diagnosed Alzheimer´s disease, which is a type of dementia.
- GLP compliance:
- no
Test material
- Reference substance name:
- Thiamine hydrochloride
- EC Number:
- 200-641-8
- EC Name:
- Thiamine hydrochloride
- Cas Number:
- 67-03-8
- Molecular formula:
- C12H17N4OS.ClH.Cl
- IUPAC Name:
- 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl)-4-methyl-1,3-thiazol-3-ium chloride hydrochloride
Constituent 1
Method
- Ethical approval:
- other: Informed consent was obtained from the patients and their next of kin
- Details on study design:
- A double-blind, placebo-controlled, randomized, crossover design was performed with patients diagnosed with probable Alzheimer´s disease according to the standard criteria.
- Details on exposure:
- TYPE OF EXPOSURE: Orally, the test substance was administered in 250 mg and 500 mg tablets, which were obtained from Rugby Laboratories (West Hempstead, NY).
EXPOSURE LEVELS:
First experiment: 3 g/day
Second experiment: 4 - 8 g/day
EXPOSURE PERIOD:
First experiment: 1 month
Second experiment: In the first phase, the first two subjects were initially administered at 3 g/day, and daily dosage incrementally increased 0.5 g/day every 2 weeks, up to 6 g/day. These patients underwent physical examination every 2 weeks. Because the first two patients tolerated dosages up to 6 g/day well without any side effects, the remaining patients were initially administered at 4 g/day, and daily dosage was increased by 1 g/day every month, up to 6 g/day. In the third phase, daily thiamine dosage was incrementally increased by 0.5 g/day each month, up to a maximum of 8 g/day. Subjects were examined and tested every 4 weeks through month 9 in phases 2 and 3 and then every 8 weeks thereafter.
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
First experiment: 18 patients (including five men and 13 women) with a mean age of 71 years (ranged from 61 to 86 years).
Second experiment: 17 patients; Of these, 6 were included from the first experiment and 11 additional subjects meeting the same diagnostic and experimental criteria were recruited. The subjects included nine men and eight women with mean age of 69 years (ranged from 54 to 93 years).
Results and discussion
- Results:
- First experiment: all patients tolerated the thiamine dose well, and no side effects were noted.
Second experiment: Most subjects tolerated the dosages well without weakness or side effects. Two subjects developed nausea and indigestion at dosages of 7.0 and 7.5 g/day, respectively. These two subjects were subsequently treated at their highest tolerated dose without side effects in the latter months (i.e., 6.5 and 7.0 g/day).
Applicant's summary and conclusion
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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