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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 701-475-3 | CAS number: -
- 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:
- 7.1 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 7.1 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 7.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Using the standard equation as outlined in ECHA R8 guidance document, corrected Inhalatory NOAEC = oral NOAEL x (1/ sRVrat) x (ABSoral-rat/ ABSinh-rat) x (sRVhuman/ wRV)
Corrected Inhalatory NOAEC = 50 mg/kg (bw)/day x (1/ 0.38m³ /kg/d) x (100 %/ 100 %) x (6.7 m³(8h) / 10 m³(8h))
Corrected Inhalatory NOAEC = 88.16 mg/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 %
Note The oral absorption of dilithium tetraborate is expected to be circa 100% in both test animals and humans. Based on the water solubility of dilithium tetraborate a 'worse case' of 100% absorption by the inhalation route is also assumed.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Combined reproductive/devlopmental/repeated dose toxicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- 1 - the allometric scaling is covered in the formula which is used
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers according to ECHA REACH Guidance (R8, 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.1 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value used
- AF for differences in duration of exposure:
- 1
- Justification:
- Reproductive/screening developmental toxicity study
- AF for other interspecies differences:
- 5
- Justification:
- Default worker value (ECHA guidance document) - There is currently insufficient chemical specific data to amend the default assessment factor for interspecies variation and therefore for workers it remains at 5 and for the general population it is 10. (Doursonet al.,1998)
- AF for intraspecies differences:
- 6
- Justification:
- Based on available data, the pregnant female is the most susceptible of the human population which is associated with the critical effect of dilithium tetraborate. Absorption and distribution within the humans is expected to be similar, with no metabolism predicted.
However, elimination/excretion during pregnancy is likely to be different. This is based on an increase in glomerular filtration rate (GFR) as a known physiological adaptation during pregnancy (Doursonet al.,1998)
Therefore, by use of the mean GFR from healthy humans in late pregnancy minus two standard deviations to take into account the variation for approximately 95% of the human population, a value of 1.8 is derived. This is then put forward as the toxicokinetic part of the intraspecies assessment factor (the default value is 3.2). (EFSA,2013; US EPA, 2004)
The default value of 3.2 for intraspecies variation (toxicodynamics) is used as a default value.
This gives a total of 1.8 x 3.2 for the intraspecies variation = 5.76 (i.e. 6) - AF for the quality of the whole database:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
It is necessary to wear appropriate eye protection and have access to eye wash stations in the areas where dilithium tetraborate is handled/stored.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1.74 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.74 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In line with ECHA guidance document (R8, 2008,p58)
Divide the NOAEL (oral dose, rat) by 1.15 m3 /kg bw to obtain the no adverse effect concentration (24 hours, general population), i.e. 50/1.15 = 43.48 mg/m3.
Then apply the appropriate assessment factors = 43.48/ 25 = 1.74 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Combined reproductive/developmental/repeated dose toxicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for intraspecies differences:
- 10
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- DNEL extrapolated from long term DNEL
- Value:
- 1.74 mg/m³
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 1.74 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
An estimate of 0.5% is proposed for dermal absorption, which is a reasonable worse case approach (SCCS, 2010). The DNEL for dermal exposure is therefore adjusted to take this into consideration.
Therfore, DNEL (Systemic, long term, dermal, general population) = 50/60 = 0.83/0.5% = 166 mg/kg (bw)
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 1
- Justification:
- Combined reproductive/developmental toxicity/repeated dose screening study
- AF for other interspecies differences:
- 10
- Justification:
- Default value (ECHA guidance document) - There is currently insufficient chemical specific data to amend the default assessment factor for interspecies variation and therefore for the general population it is 10. (Doursonet al.,1998)
- AF for intraspecies differences:
- 6
- Justification:
- Based on available data, the pregnant female is the most susceptible of the human population which is associated with the critical effect of dilithium tetraborate. Absorption and distribution within the humans is expected to be similar, with no metabolism predicted.However, elimination/excretion during pregnancy is likely to be different. This is based on an increase in glomerular filtration rate (GFR) as a known physiological adaptation during pregnancy (Doursonet al.,1998)
Therefore, by use of the mean GFR from healthy humans in late pregnancy minus two standard deviations to take into account the variation for approximately 95% of the human population, a value of 1.8 is derived. This is then put forward as the toxicokinetic part of the intraspecies assessment factor (the default value is 3.2). (EFSA,2013; US EPA, 2004)
The default value of 3.2 for intraspecies variation (toxicodynamics) is used as a default value.
This gives a total of 1.8 x 3.2 for the intraspecies variation = 5.76 (i.e. 6) - AF for the quality of the whole database:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.83 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.83 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The study upon which the DNEL is based was a repeated dose oral study (OECD TG422)
- AF for dose response relationship:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for other interspecies differences:
- 10
- Justification:
- There is currently insufficient chemical specific data to amend the default assessment factor for interspecies variation and therefore for workers it remains at 5 and for the general population it is 10. (Doursonet al.,1998)
- AF for intraspecies differences:
- 6
- Justification:
- Based on available data, the pregnant female is the most susceptible of the human population which is associated with the critical effect of dilithium tetraborate. Absorption and distribution within the humans is expected to be similar, with no metabolism predicted.
However, elimination/excretion during pregnancy is likely to be different. This is based on an increase in glomerular filtration rate (GFR) as a known physiological adaptation during pregnancy (Doursonet al.,1998)
Therefore, by use of the mean GFR from healthy humans in late pregnancy minus two standard deviations to take into account the variation for approximately 95% of the human population, a value of 1.8 is derived. This is then put forward as the toxicokinetic part of the intraspecies assessment factor (the default value is 3.2). (EFSA,2013; US EPA, 2004) - AF for the quality of the whole database:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- Standard default value according to ECHA REACH Guidance (R8, 2012).
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the long term DNEL (consumer, oral, long term) will protect against any potential short term acute oral exposures.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Appropriate labelling to highlight the need to avoid eye contact
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.