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Diss Factsheets
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EC number: 241-004-4 | CAS number: 16940-66-2
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.1 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 240 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 30
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Worker-DNELlong-term, inhalation, systemic
No animal studies for the inhalation route are available for sodium borohydride or boric acid. Therefore a NOAEC was extrapolated from the boric acid oral key study using the BMDL05 of 10.3 mg B/kg bw/day. An eight hour workday and an according respiratory volume of 10 m3are assumed. The corrected inhalatory NOAEC of 18.16 mg B/m3was calculated as recommended by Chapter R.8 from the Guidance on IR and CSA using the following equation:
Corrected Inhalatory NOAEC = oral BMDL5x (1/ sRVrat) x (ABSoral-rat/ ABSinh-rat) x (sRVhuman/ wRV)
Corrected Inhalatory NOAEC = 10.3 mg B/kg bw/day x (1/ 0.38m3/kg/d) x (100%/ 100%) x (6.7 m3(8h)/ 10 m3(8h))
Corrected Inhalatory NOAEC = 18.16 mg B/m3
sRV: standard Respiratory Volume
ABS: Absorption,
wRV: worker Respiratory Volume
sRVrat= 0,38 m3/day
sRVhuman= 6,7 m3/day (8h);
sRVhuman, moderate work= 10 m3/day (8h)
ABSoral-rat= ABSinh-human= 100%
Absorption of boric acid and tetraborates via the oral route is close to 100 %. Due to the good water solubility of the compounds and studies in animals and humans a realistic worst case assumption of 100 % absorption via the inhalation route is justified. Borates exist predominantly as un-dissociated boric acid in dilute aqueous solution at physiological pH, it is not further metabolized, therefore it can be concluded that the main species in the plasma of mammals is un-dissociated boric acid, and as such can exert its toxic effects in the target organs.The toxicokinetics of boric acid and disodium tetraborates are similar in rats and humans with regard to absorption, distribution, and metabolism. Differences exist for renal clearance, which is approximately 3 times faster in rats compared to humans. The physiological process of renal clearance is affected by the basal metabolic rate. In the above stated formular differences with regard to metabolic rate between rats and humans are considered. As recommended by Chapter R.8 from the Guidance on IR and CSA the remaining inter-species differences are covered by applying the factor 2.5 for toxicodynamic differences and the factor 5 for intraspecies variability within the working population. An additional factor for uncertainties caused by route-to-route extrapolation was considered not necessary.
Worker-DNELlong-term, inhalation, systemic = (18.16 mg B/m3)/(2.5 x 5) = 1.45 mg B/m3 or 5.1 mg NaBH4 / m3
Worker-DNELlong-term, inhalation, systemic
The dermal DNEL refers to mg Sodiumborohydride/kg bw/day and is derived from data on boric acid. No relevant animal studies for the dermal route are available. Therefore a NOAEC was extrapolated from the boric acid oral key study using the BMDL05 of 10.3 mg B/kg bw/day (36 mg NaBH4/kg bw/day). For risk assessment of borates a dermal absorption of 0.5 % is used as a worst case approach. The assessment factors applied are for interspecies variability (5) and intraspecies variability (6).
The dermal DNEL is derived for information purpose. Corrosivity of SBH will determine the PPE requirements.
Local Effects
Respiratory irritation may be an endpoint of relevance, especially for a corrosive substance such as sodium borohydride. To take this into consideration, the mouse RD50 of 0.44mg/l (IUCLID Section 7.9.3, Hilaski 2001) was extrapolated to a human respiratory irritation LOAEL based on the correlation published by Kuwabara et al. 2007 (EHS 115:1609 -1616):
log RD50 = 1.16 (log LOAEL) + 0.77
The extrapolated human LOAEL is 0.1069 mg/l, or 107 mg/m3. Considering that the DNEL for systemic effects is 5.1 mg/m3, it can be reasonably assumed that the long-term systemic inhalation DNEL is also protective of respiratory irritation effects.
A DNEL dermal for acute local effects will not be derived due to the corrosivity of the substance. A qualitative risk assessment is provided to evaluate risk management measures.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- BMDL05
- Value:
- 10.3 mg/kg bw/day
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Sodium borohydride is not applied in any consumer use, so that DNELs for the general populations are not required. The DNEL is only depicted for information purpose.
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.
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