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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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Effects of Excess Thiamine and Pyridoxine on Growth and Reproduction in Rats
- Author:
- Morrison, A.B. and Sarett H.P.
- Year:
- 1 959
- Bibliographic source:
- J. Nutrition 69:111-116
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was conducted to determine whether excess amounts of thiamine hydrochloride affected growth and reproductive performance in female rats. The female rats of the control group were fed with a basal diet containing 1.5 mg thiamine hydrochloride per 1 kg of diet. For the treatment group the feed was supplemented with 50 times of this level, resulting in a diet containing 75 mg/kg food. Records were kept of the amounts of food and water consumed by each rat, and the animals were weighed individually at weekly intervals. After an exposure duration of 12 weeks, the animals were mated with stock males of proven fertility. As soon as possible after each hitter was born, the number and weight of the young were recorded. When necessary, the number of young per litter was reduced to 8 at 5 days of age.
- GLP compliance:
- no
- Limit test:
- 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
Test animals
- Species:
- rat
- Strain:
- other: McCollum-Wisconsin
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 19 - 21 days
- Weight at study initiation: 50 g
- Housing: The animals were individually housed in screen-bottom cages.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- Females were mated with stock males of proven fertility.
- Analytical verification of doses or concentrations:
- no
- Frequency of treatment:
- (P) Females: 12 weeks before mating, during mating, during resulting pregnancies and until lactation day 21, through weaning of their F1 offspring.
(F1) Males and Females: 19 - 21 days, until weaning - Details on study schedule:
- - Age at mating of the mated animals in the study: approximately 15 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 75 mg/kg diet
- Remarks:
- basal diet contained 1.5 mg thiamine hydrochloride per kg food and was supplemented with 50 times of this level, resulting in a diet containing 75 mg/kg food.
- Dose / conc.:
- 9 mg/kg bw/day (nominal)
- Remarks:
- a default factor of 0.12 for rats was used for converting test substance concentrations in feed (mg/kg) into daily dose (mg/kg bw per day) as described in a scientific opinion from EFSA (EFSA Journal 2012;10(3):2579).
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- BODY WEIGHT: Yes, the body weight of the female rats were recorded weekly.
FOOD CONSUMPTION AND FOOD EFFICIENCY:
Amounts of food consumed by each rat were recorded.
WATER CONSUMPTION:
Amounts of water consumed by each rat were recorded. - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 5 postpartum: when neccesary, the number of young per litter was reduced to 8
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: as soon as possible after each litter was born, the number and weight of the pups were recorded. Thereafter, weight gain was recorded on lactation day 21 again. Postnatal mortality was determined on lactation day 5 and 21, respectively. - Postmortem examinations (parental animals):
- SACRIFICE
- Maternal animals: All surviving animals were sacrificed by intraperitoneal injection of Nembutal solution after the F1 generation had reached 21 days of age.
GROSS NECROPSY
- Gross necropsy consisted of the examination of liver, kidneys and adrenals. These organs were removed and weighted. In addition, the livers of each treatment group were pooled and analyzed for solids, total lipids and thiamine content.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Control: 1/12 females died.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- calculated
- Effect level:
- 9 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effects were observed at the dose level of 75 mg/kg of diet
- Remarks on result:
- other: a default factor of 0.12 for rats was used for converting test substance concentrations in feed (mg/kg) into daily dose (mg/kg bw per day) as described in a scientific opinion from EFSA (EFSA Journal 2012;10(3):2579).
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Control: 98% survived from day 0 to day 5 and 73% survived from day 0 to day 21
75 mg/kg diet: 96% survived from day 0 to day 5 and 76% survived from day 0 to day 21
There was no difference between the survival rates of control and treatment group, therefore the effect was considered to be non-treatment related. - Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- calculated
- Generation:
- F1
- Effect level:
- 9 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed in the F1 generation
- Remarks on result:
- other: a default factor of 0.12 for rats was used for converting test substance concentrations in feed (mg/kg) into daily dose (mg/kg bw per day), as described in a scientific opinion from EFSA (EFSA Journal 2012;10(3):2579).
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The source substance had no effect on reproductive performance.
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