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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-08-11 1 2004-09-08
- 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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, 2003
- Type of study:
- mouse local lymph node assay (LLNA)
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: 95%
- Lot/batch No.: LOT 30102
- Expiration date of the lot/batch: December 01, 2004
- Storage condition of test material: at room temperature at about 20°C, away from sunlight under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, B.V. Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: 8- 12 weeks
- Weight at study initiation: 16 – 24 g
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding (“Lgnocel”, Schill AG, CH-4132 Muttenz, Switzerland)
- Diet (e.g. ad libitum): 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: Under test conditions under health examinations.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Pre-test: 2.5%, 5%, 10% and 25%
Main test: 0, 5%, 10% and 25% - No. of animals per dose:
- Pre-test: 2 females
Main test: 4 females - Details on study design:
- RANGE FINDING TESTS:
- Irritation: 24 h after single topical application of 2.5%, 5%, 10% and 25% to the ears of two females, no irritation was observed at all concentrations.
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph node Assay (LLNA)
- Criteria used to consider a positive response:
The proliferation response of lymph node cells was expressed as the number of radioactive disintegration per minute per lymph node and as ratio of 3HTdR incorporated into lymph node cells of the test group relative to control group values.
The test item was regarded as sensitizer if the following criteria are fulfilled:
- Exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater the control values as indicated by the stimulation index SI
- The data are compatible with a dose response, although allowance must be made for local toxicity or immunological suppression
TREATMENT PREPARATION AND ADMINISTRATION:
Animals were treated by topical application of 25 µl solution of test substance in DMF to the dorsal surface of each ear lobe once a day for three consecutive days. Five days after the first application, all mice received application of 250 µl of 73.3 µCi/ml 3HTdR by intravenous injection. Five hours after this treatment all animals were sacrificed and lymph nodes were excised and prepared for determination of incorporated 3HTdR. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5%: 0.7 10%: 1.2 25%: 1.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean over 8 lymph nodes): Vehicle control: 2357 5%: 1741 10%: 2784 25%: 2598
Any other information on results incl. tables
Viability: No mortality was noted.
Clinical signs: No symptoms of local toxicity at the ears and no signs of systemic was noted in all animals during the study.
Body weights: The body weights of all animals were within the range commonly recorded for the animals of the strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sodium triacetoxyborohydride did not induce an increase incorporation in mouse lymph node cells and thus was found to be a non-sensitizer .
- Executive summary:
Sodium triacetoxyborohydride was tested for sensitizing properties in a Local Lymph Node Assay (LLNA) performed according to GLP and OECD 429. Groups of 4 female CBA mice were treated by topical application of 25 µl solution of 5%, 10% and 25% Sodium triacetoxyborohydride in DMF to the ears once daily for three consecutive days. The resulting stimulating indices (SI) were 0.7, 1.2 and 1.1, respectively. Thus, Sodium triacetoxyborohydride was not sensitizing under the condition of this test.
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