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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 200-641-8 | CAS number: 67-03-8
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitsation) - [study scientifically not necessary / other information available]
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VIII, information requirement 8.5.3 (acute toxicity by dermal route) testing is not considered to be appropriate because skin contact in production and/or use is unlikely. Furthermore, in vivo acute oral toxicity studies have revealed that the substance does not require classification for STOT-SE by the oral route, in vitro skin corrosion/irritation and skin sensitisation studies do not indicate effects following dermal exposure to the substance and no systemic toxicity is predicted.
Although no dermal toxicity study was performed with thiamine hydrochloride it can be seen from the acute oral toxicity studies that the substance is of low acute toxicity. Two study reports are available for the acute oral endpoint (Bächtold Report No. 3191, 1970 and Bächtold Report No. 6474, 1976). The resulting LD50s were above 10000 mg/kg bw both in mice and in rats. As a consequence, Thiamine hydrochloride has not to be classified with regards to that endpoint.
Furthermore e request that the following points are also considered in support of the proposed waiver:-
- Usually acute oral toxicity drives the hazard classification (Moore et al., 2013).
- Based on the general accepted assumption that dermal absorption will not be higher than oral absorption, acute dermal toxicity of Thiamine hydrochloride is expected to result in a LD50 > 10000 mg/kg/bw.
- It is described in the EU Commission Regulation 2016/863 that there is scientific evidence for expecting substances that are not toxic via the oral route to be also non-toxic via the dermal route. Therefore, additional testing with dermal application is considered unlikely provide essential information for the safety assessment.
- Further testing is not warranted for animal welfare reasons.
References
Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity
Moore et al., 2013: Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classification under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Reg Tox Pharm 66(1): 30-37
Data source
Materials and methods
Results and discussion
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.