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Diss Factsheets
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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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- 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:
- A Toxicity Study of Parenteral Thiamine Hydrochloride
- Author:
- Wrenn et al.
- Year:
- 1 989
- Bibliographic source:
- Ann Emerg Med. 18:867-870
Materials and methods
- Endpoint addressed:
- other: repeated dose toxicity: other routes
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The safety of the test substance was evaluated after administration intravenously as a 100 mg bolus in 989 consecutive patients. In total 1070 doses were administered. Four patients received large-dose thiamine for overt Wernicke's encephalopathy; two received 1 g in multiple 100 mg boluses and two received 300 mg in multiple 100 mg boluses within the first few hours of being seen. For purposes of analysis, these were considered single doses. There were 39 instances (3.9% of the total population) in which individual patients received between two and seven individual doses over the entire study period. One patient received seven doses, two received six, three received five, two received four, 16 received three, and 15 received two doses.
- 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
- Type of population:
- other: patients
- Subjects:
- - Number of subjects exposed: 989 patients
- Sex: 795 men (80%) and 194 women (20%)
- Age: 16 - 80 years
- Known diseases: alcoholism (65%), alcohol withdrawal (0.9%), alcoholic seizure (13%), alcoholic hypoglycemia (0.8%), seizures (7%), hypoglycemia (1%), hypothermia (1%), malnutrition (0.3%), cancer (0.1%), cocaine (0.2%), AIDS (0.8%), altered mental status (0.9%), sepsis ( 0.1%), drug overdose (0.7%), dehydration (0.2%), hypertension (0.1%), nausea or vomiting (0.5%), cerebrovascular accident (0.2%) and unknown (7%) - Ethical approval:
- confirmed, but no further information available
- Route of exposure:
- other: intravenous (IV bolus)
- Reason of exposure:
- intentional
- Details on exposure:
- Over a 6-month period, 1070 doses of the test substance were administered by rapid IV push technique to 989 patients. Four patients received large-dose thiamine for overt Wernicke's encephalopathy; two received 1 g in multiple 100 mg boluses and two received 300 mg in multiple 100 mg boluses within the first few hours of being seen. For purposes of analysis, these were considered single doses
- Examinations:
- Cardiac monitor: 94 patients were incidentally on a cardiac monitor at the time of the study.
Results and discussion
- Clinical signs:
- Adverse reactions were observed in 12 cases (1.1%). In 11 of the cases, transient burning occurred immediately after injection in the arm with the IV line and lasted from seconds to minutes. The authors considered this a minor reaction with no allergic or immune component. Of these 11 patients, seven were men and four were women (1.75:1 ratio). The 12th case, transient generalized pruritus without any other associated symptoms was observed in the patient; the authors considered this a potentially major reaction. The rates of minor and major reactions, therefore, were 1.02 and 0.093%, respectively. No adverse systemic effects were reported.
- Results of examinations:
- Cardiac monitor: No arrhythmias were noted.
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.
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.