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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: 10 days
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1974
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No details on purity of test substance. No guideline followed. Parameters addressed limited to body weight and mortality. No control group included.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats and mice were exposed daily via oral gavage for ten days. Body weight was meassured on day 0, 5 and 11. Mortality was determined daily.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Pyridoxine hydrochloride
- EC Number:
- 200-386-2
- EC Name:
- Pyridoxine hydrochloride
- Cas Number:
- 58-56-0
- Molecular formula:
- C8H11NO3.ClH
- IUPAC Name:
- 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): Pyridoxin-hydrochlorid
- Lot no.: Mag-No 1160, A/364462
Constituent 1
Test animals
- Species:
- other: rat and mice
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 20 g (mice), 50 g (rats)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: gum arabic
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2000, 4000, 8000 and 16000 mg/kg bw (mice)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
500, 1000, 2000, 4000, 8000 and 16000 mg/kg bw (rats)
Basis:
actual ingested
- No. of animals per sex per dose:
- No data
- Control animals:
- no
- Details on study design:
- Observation period: 20 days (10 days observation after last dose)
Examinations
- Observations and examinations performed and frequency:
- Mortality was checked at least daily. Weight was determined on day 0, 5, 10 and 20.
- Sacrifice and pathology:
- No data.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Observations in mice:
No mortality was observed at 2000 mg/kg bw/ day. At 4000 mg/kg, mortality was 30% on day 2, 50% on day 3, and 60% on day 8 until the end of the observation period. At 8000 mg/kg bw, 10% of the mice died on day 1, all others on day 2. At the highest dose of 16000 mg/kg bw, no mice survived the first exposure.
On day 5and 10, the mice exposed to 4000 mg/kg bw/ day suffered body weight loss (- 12% and -17.5% resp.). The group exposed at 2000 mg/kg bw had a slight body weight increase compared to the start weight on both days (on average + 8% and 15.5% for days 5 and 10 resp.).
Observations in rats:
No rats survived 16000 mg/kg bw (100% mortality day 1) and 8000 mg/kg bw/ day (80% mortality day 1, 100% mortality day 2). At 4000 mg/kg bw/ day, 50% of the rats died on day 3, on day 4 and 5 mortality increased to 80% and 100%. At 2000 mg/kg bw/ day, 10% of the rats died on day 3, mortality on day 6 increased to 60%, and on day 7 to 80%. No rats survived more than 8 days exposure to 2000 mg/kg bw/ day. At 1000 mg/kg bw/ day, no mortality occurred up to day 9 (10% mortality), no other rats died at this dose level. All rats survived 500 mg/kg bw/ day.
Rats at 2000 mg/kg bw/ day had a decreased body weight at day 5 compared to day 0 (-15%). Rats exposed to 500 and 1000 mg/kg bw/ day had an increased body weight on day 5 (+46.8% and + 37.6% resp.) and day 11 (+89.4% and + 67.6% resp.) compared to their weight at day 0.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Rats and mice were orally exposed to pyridoxine hydrochloride for 10 days. Only at the lowest test doses (2000 mg/kg bw/day (mice) and 500 mg/kg bw/ day (rats)) no mortality was seen. Rats and mice dosed at the highest dose (16000 mg/ kg bw/ day) died on the first day. At 8000 mg/kg bw/ day, exposed mice and rats died after second dosing. Pyrodoxin-hydrochlorid influenced body weight gain of mice and rats in a dose-dependent way.
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