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Diss Factsheets
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EC number: 200-386-2 | CAS number: 58-56-0
- 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
Endpoint summary
Administrative data
Description of key information
Company data and peer-reviewed literature do not indicate oral and dermal toxicity of pyridoxine-hydrochloride below 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No rough data are included (calculated LD values only). No data on number of animals tested per concentration. No details on clinical signs or gross pathology. The test was performed in mice. Observation time limited to 10 days.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female mice were exposed to three different concentration of the test substance and observed for at least ten days.
- GLP compliance:
- no
- Test type:
- other: no details on study design
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 18-22 g - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- Animals were observed for at least 10 days.
- Doses:
- 3500, 7000 and 14000 mg/kg bw
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- Ten batches were tested.
- Statistics:
- OLIVETTI calculator was used to detrmine LD values.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 6 994 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 10 day observation period; calculated value
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 3 344 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 10 day observation period
- Mortality:
- One animals died within 24 hours, some animals died after the first 24 hours but within the observation time of 10 days.
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity of ten batches of pyridoxine-hydrochlorid was tested in mice. After 10 days observation period, the LD0 was found to be 3344 mg/kg bw. The LD50 was calculated based on results of 10 batches and found to be 6994 mg/ kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data derived from peer-reviwed handbook.
- Principles of method if other than guideline:
- No details are given on test protocol.
- GLP compliance:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 4 000 mg/kg bw
- Based on:
- test mat.
- Conclusions:
- In peer-reviewed literature, the LD50 for acute oral toxicity of the test substance in rat was found to be 4000 mg/kg bw and in mice 5500 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No details on test substance (Lot, purity), no details on test protocol (number of animals, doses tested). Observation time limited to 10 days.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Ten different batches of the test substance were tested in 3 concentrations. Animals were observed for at least 10 days.
- GLP compliance:
- no
- Test type:
- other: no details on study design
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Details on study design:
- Observation period was ten days
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 7 750 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 6 600 - < 8 900
- Remarks on result:
- other: 10 days observation, calculated value
- Sex:
- not specified
- Dose descriptor:
- other: LD10
- Effect level:
- 4 940 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 10 days observation, calculated value
- Sex:
- not specified
- Dose descriptor:
- other: LD90
- Effect level:
- 12 160 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 10 days observation, calculated value
- Mortality:
- Some animals died within 24 hours, some animals died after the first 24 hours but within the observation time of 10 days.
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The oral toxicity of pyridoxine-hydrochloride was tested in rats. As the LD10 after 10 days was found to be 4940 mg/ kg bw, the test substance is not classified for oral toxicity.
Referenceopen allclose all
Other data in this handbook:
rat- scu LD50 = 3000 mg/kg
rat- ivn LD50 = 530 mg/kg
mouse- oral LD50 = 5500 mg/kg bw
mouse- scu LD50 = 2450 mg/ kg
mouse- ivn LD50 = 660 mg/ kg
cat- scu LDL0 = 1000 mg/ kg
cat- ivn LD50 = 560 mg/ kg
cat- ims LD50 = 500 mg/ kg
rabbit- ivn LD50 = 464 mg/ kg
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Company data is available on the acute oral toxicity of the test substance in rat and mouse (Klimisch 2). Furthermore, data from peer-reviewed literature source is available.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The oral toxicity of pyridoxine-hydrochloride was tested in rats.The LD10 after 10 days was found to be 4940 mg/ kg bw. The acute oral toxicity of ten batches of pyridoxine-hydrochlorid was tested in mice. After 10 days observation period, the LD0 was found to be 3344 mg/kg bw. The LD50 was calculated based on results of 10 batches and found to be 6994 mg/ kg bw. In peer-reviewed literature, the LD50 for acute oral toxicity of the test substance in rat was found to be 4000 mg/kg bw and in mice 5500 mg/kg bw.
The acute dermal toxicity test is not a data requirement for Annex VII. Moreover, according to Competent Authorities for REACH and CLP (CARACAL) agreement to amend REACH Annex VIII (point 8.5.3) to waive this endpoint for substances that have not shown oral acute toxicity up to a limit dose of 2000 mg/kg bw in absence of indications that dermal adsorption exceeds oral adorption. Furthermore, data from peer-reviewed literature source report an LD50 of 2450 mg/ kg in mice.
Justification for selection of acute toxicity – oral endpoint
No single study was selected, endpoint conclusion derived based on
weight-of-evidence.
Justification for classification or non-classification
As the available data do not indicate toxic effects after single exposure, pyridoxine-hydrochloride is not classified for acute toxicity according to Regulation (EC) No 1272/2008.
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.