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EC number: 435-580-8 | CAS number: 56553-60-7
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-06-10 - 2005-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study according GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 435-580-8
- EC Name:
- -
- Cas Number:
- 56553-60-7
- Molecular formula:
- C6H10BNaO6
- IUPAC Name:
- sodium bis(acetyloxy)boranuidyl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sodium triacetoxyborohydride
- Physical state: solid
- Analytical purity: 98%
- Lot/batch No.: STAB50104
- Expiration date of the lot/batch: January 04, 2006
- Storage condition of test material: at room temperature at about 15-25°C, protected from light and moisture under nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Laboratory Animal Service, CH-Füllinsdorf, Switzerland
- Age at study initiation: 6 weeks
- Weight at study initiation: mean 143.4 g (males), mean 120.0 g (females)
Housing: In groups of five in Macrolon type-4 cages with wire mesh tops and standard softwood bedding (“Lignocell”, Schill AG, CH-4132 Muttenz, Switzerland
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch No. 54/03 and 78/03 (Provimi Kliba AG, CH-4303 Kaiseraugst, Switzerland); ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf; ad libitum
- Acclimation period: 7 days, under test conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Desiccated corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was daily freshly prepared by weighing into a glass beaker and mixing with vehicle.The mixture was perpared using magnetic stirrer and used at room temperature (15-25°C)
VEHICLE
- Justification for use and choice of vehicle (if other than water): Since test usbstance decomposes in water, desiccated corn oil was chosen as vehicle.
- Amount of vehicle (if gavage): 5 mL/kg bw
- Lot/batch no. (if required): Charge 11570660 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration, homogeneity and stability (after 2 hours) of the dose formulations were determined in samples taken after experimental start. Concentration and homogeneity of dose formulations were determined during week 3 of treatment.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100 and 300 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 mg/kg bw/d: 5 males and 5 females
100 mg/kg bw/d: 5 males and 5 females,
300 mg/kg bw/d: 5 males and 5 females; additionally 5 males and 5 females for recovery group
Control: 5 males and 5 females; additionally 5 males and 5 females for recovery group - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: doses were selected based on results of a 5-day oral toxicity study (Report A05308)
- Post-exposure recovery period in satellite groups: 14 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Observations for clinical signs once before administration, twice daily on days 1-3, once daily during days 4-28 and during recovery period on days 29-42
- Cage side observations checked in table were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: in random sequence once before administration and once weekly during weeks 1-3
BODY WEIGHT: Yes
- Time schedule for examinations: weekly during acclimatization, treatment and recovery and before necropsy
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 4 weeks (all groups), after 6 weeks (recovery groups), early in the morning
- Anaesthetic used for blood collection: Yes (Isoflurane)
- Animals fasted: Yes (approx. 18 h)
- How many animals: all animals of the designated groups
- Parameters checked in table were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks (all groups), after 6 weeks (recovery groups)
- Anaesthetic used for blood collection: Yes (Isoflurane)
- Animals fasted: Yes (approx. 18 h)
- How many animals: all animals of the designated groups
- Parameters checked in table were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: after 4 weeks (all groups), after 6 weeks (recovery groups)
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes (approx. 18 h)
- Parameters checked in table were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: During week 4
- Dose groups that were examined: All animals
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Follwing statistical methods were used for analysis of grips strenght, locomotor activity, body weights, organ weights and ratios:
- Dunnett-test
-Steel-test
- Fisher's exact test
Follwing statistical method was used for analysis of clinical laboratory data:
- One-way ANOVA
- DunnettTest
-Kruskal-Wallis test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- observed in the moribund rats
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- observed in the moribund rats
- 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):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- observed in the moribund rats
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- observed in the moribund rats
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two males pf the high dose group died before scheduled necropsy, one on day 2 and one was killed on day 12 for ethical reasons.
No test-related clinical signs were noted. Only noted findings included piloerection, salivation, hunched posture, sedation, rales, emaciation and distended abdomen in the male sacrificed for ethical reasons.
BODY WEIGHT AND WEIGHT GAIN
No changes in body weight an all animals of all dose groups were compared to control groups were noted.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
During treatment and recovery period, the mean daily food consumption values of treated animals of all dose groups were unaffected.
HAEMATOLOGY
After the end of the treatment and recovery period, no differences of toxicological relevance were seen in all treated animals.
CLINICAL CHEMISTRY
After the end of the treatment and recovery period, no differences of toxicological relevance were seen in all treated animals.
URINALYSIS
After the end of the treatment and recovery period, no differences of toxicological relevance were seen in all treated animals.
FUNCTIONAL OBSERVATION BATTERY
No clinical signs of toxicological relevance were evident. The mean fore- and hindlimb grip strength values of all treated animals were unaffected. No substance-related changes in locomotor activity was seen.
ORGAN WEIGHTS
No substance-related changes were noted after treatment or recovery periods in the mean absolute or relative organ weights in all treated animals.
GROSS PATHOLOGY
With exception of the two animals sacrificed before scheduled necropsy, all macroscopical changes noted in the remaining substance-treated animals were considered to be in the range of normal background lesions seen in rats of this strain and age. Thus the noted lesions were considered incidental reflecting the usual individual variability and not substance-related.
The male died on day 2 had incomplete lung deflation and dark red discoloration of the mandibular lymph nodes and salivary glands. The animals sacrificed for ethical reasons had distension of the entire digestive tract with multiple crateriform red to dark-red retractions of the stomach fundus and hyposplenia which was considered to the reactive nature of the substance.
HISTOPATHOLOGY: NON-NEOPLASTIC
No substance-related microscopical changes were noted after treatment or recovery periods in all treated animals, except the animal sacrificed for ethical reasons. This animal had several foci of mucosal necrosis with mild gastric haemorrhage , mild luminal dilation of the ileum and colon and minimal luminal dilation of the rectum. No substance-related microscopic findings were evident in rats necropsied after recovery period.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Absence of substance-related systemic effects
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Absence of substance-related systemic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the absence of substance-related systemic effects in male and female Wistar rats treated for 28 days, the NOAEL of 300 mg/kg bw/d was determined for Sodium triacetoxyborohydride.
- Executive summary:
Oral toxicity of Sodium triacetoxyborohydride after repeated dosing for 28 day was evaluated in a GLP study performed according OECD guideline 407. Groups of 5 male and female Wistar rats received 30, 100 and 300 mg/kg bw/d in desiccated corn oil by gavage for 28 days. Additional groups were treated with control only and 300 mg/kg bw/d for 28 days had a recovery period of 14 days. Clinical signs and mortality, body weight, food consumption, clinical chemistry data and functional observation battery was analysed during and at the end of the treatment period. After necropsy macroscopic and microscopic changes were recorded. Two males of the high dose groups died prior to scheduled necropsy, but the effects were considered to the reactive nature of the substance. No substance related systemic effects were noted on all the other treated animals. Based on these findings, the NOAEL was determined to be 300 mg/kg bw/d, the highest dose tested.
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