Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 456-990-3 | CAS number: 244761-29-3 LITHIUM-BIS(OXALATO)BORATE
- 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:
- 1.23 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 30.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 25 mg/kg bw /day was determined for the registered substance in an oral sub-chronic toxicity study in rats (OECD TG 408, GLP).
This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (based on ECHA Guidance R.8 the absorption rate of the starting route is by the factor of 2 lower than the one of the end-route in case of route to route extrapolation from oral to inhalation) and the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEC corrected = 25 mg/kg bw/day * 1/0.38 m³/kg/day * 0.5 * (6.7 m³/10 m³) * 1.4 = 30.8 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not applicable for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 39.2 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 125
- Dose descriptor starting point:
- other: LD0
- Value:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LC0
- Value:
- 4 900 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There is experimental data for acute toxicity by the oral and inhalatory route. The acute DNEL is derived from the acute oral and acute inhalation toxicity study. The most conservative DNEL is then selected.
Oral acute toxicity as starting point
The oral LD0 of 175 mg/kg bw was converted into a corrected inhalatory LC0 taking into account the standard respiratory factor for 15 min of 1/0.012 m³/kg (0.0008 m³/min/kg bw * 15 min), the absorption rates (oral 50 %, inhalation 100 %) and the standard respiratory volume in humans/ worker respiratory volume (0.21 m³/person in 15 min / 0.3125 m³ (15 min)). For details on underlying assumtions and calculations see below.
Guidance R8 Table R8 -2:
Respiratory volume (standard) in rat : 0.8 L/min/kg bw converted to 0.0008 m³/min/kg
Respriatory volume (standard) in human, 8h: 6.7 m³/person / 480 (8h * 60 min) *15 min; Respiratory volume light acitvity 8h: 10m³/person / 480 (8h*60min) *15 min
LC0 corrected = 175 mg/kg bw * 1/(0.012 m³/kg) * 50/100 * (0.21 m³/0.3125 m³) = 4900 mg/m³
Inhalation acute toxicity as starting point
The inhalative LC0 of 5220.8 mg/m³ was converted into a corrected inhalatory LC0 by applying the Haber's Law to correct for the study duration.
Haber's Law: Cn * t = k,
where ‘C’ is the concentration, ‘n’ is a regression coefficient, ‘t’ is the exposure time and ‘k’ is a constant; a default value of n=3 for extrapolating from longer to shorter exposure durations is used.
(C³ x t) = (C') ³ x t', giving C' = C x (t/t')0.333333. C' is the sought concentration. C' = 5220.8 mg/m³ x (4h/0.25h)0.3333333 = 13155.6 mg/m³. The concentration of 13155.6 mg/m³ was adjusted for the differences in the respiratory rates by normal conditions and by light activity: 0.21 m³/0.3125 m³
LC0 corrected = 13155.6 mg/m³ * 0.21 m³/0.3125 m³ = 8770.4 mg/m³
- AF for dose response relationship:
- 10
- Justification:
- The LC0 is considered as LOAEC. To account for the uncertainties for the use of an acute toxicity study to derive a NOAEC the highest assessment factor of 10 for the LOAEL to NOAEL extrapolation proposed by the ECHA Guidance R.8 is used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not applicable for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 25 mg/kg bw /day was determined for the registered substance in a sub-chronic oral toxicity study in rats (OECD TG 408, GLP). This value was converted into the corrected NOAEL taking into account the absorption rates (based on the physicochemical properties and toxicological profile of the registered substance, an oral absorption rate of 100 % and a dermal absorption rate of 10 % are assumed as worst-case assumptions) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEL corrected = 25 mg/kg bw/day * 100/10 * 1.4 = 350 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.218 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 25 mg/kg bw /day was determined for the registered substance in a sub-chronic oral toxicity study in rats (OECD TG 408, GLP).
This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day and the absorption rates (based on ECHA Guidance R.8 the absorption rate of the starting route is by the factor of 2 lower than the one of the end-route in case of route to route extrapolation from oral to inhalation).
NOAEC corrected = 25 mg/kg bw/day * 1/1.15 m³/kg/day * 0.5 = 10.9 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not applicable for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.2 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 250
- Dose descriptor starting point:
- other: LD0
- Value:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LC0
- Value:
- 7 291.67 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There is experimental data for acute toxicity by the oral and inhalatory route. The acute DNEL was derived from the acute oral and acute inhalation toxicity study. The most conservative DNEL is then selected.
Oral acute toxicity as starting point
The oral LD0 of 175 mg/kg bw was converted into a corrected inhalatory LC0 taking into account the standard respiratory factor for 15 min of 1/0.012 m³/kg (0.0008 m³/min/kg bw * 15 min) and the absorption rates (oral 50 %, inhalation 100 %). For details on underlying assumtions and calculations see below.
Guidance R8 Table R8 -2:
Respiratory volume (standard) in rat : 0.8 L/min/kg bw converted to 0.0008 m³/min/kg
Respriatory volume (standard) in human, 8h: 6.7 m³/person / 480 (8h * 60 min) *15 min;
LC0 corrected = 175 mg/kg bw * 1/0.012 m³/kg * 50/100 = 7291.67 mg/m³
Inhalation acute toxicity as starting point
The inhalative LC0 of 5220.8 mg/m³ was converted into a corrected inhalatory LC0 by applying the Haber's Law to correct for the study duration.
Haber's Law: Cn * t = k,
where ‘C’ is the concentration, ‘n’ is a regression coefficient, ‘t’ is the exposure time and ‘k’ is a constant; a default value of n=3 for extrapolating from longer to shorter exposure durations is used.
(C³ x t) = (C') ³ x t', giving C' = C x (t/t')0.333333. C' is the sought concentration. C' = 5220.8 mg/m³ x (4h/0.25h)0.3333333 = 13155.6 mg/m³.
LC0 corrected = 13155.6 mg/m³
- AF for dose response relationship:
- 10
- Justification:
- The LC0 is considered as LOAEC. To account for the uncertainties for the use of an acute toxicity study to derive a NOAEC the highest assessment factor of 10 for the LOAEL to NOAEL extrapolation proposed by the ECHA Guidance R.8 is used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient quality of the database
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 25 mg/kg bw /day was determined for the registered substance ina sub-chronic oral toxicity study in rats (OECD TG 408, GLP). This value was converted into the corrected NOAEL taking into account the absorption rates (based on the physicochemical properties and toxicological profile of the registered substance, an oral absorption rate of 100 % and a dermal absorption rate of 10 % are assumed as worst-case assumptions).
NOAEL corrected = 25 mg/kg bw/day * 100/10 = 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.125 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 25 mg/kg bw /day was determined for the registered substance in a sub-chronic oral toxicity study in rats (OECD TG 408, GLP).
This value does not have to be corrected as the oral absorption rate of rats and humans are considered to be identical (100 % as worst-case assumption).
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- default for sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient quality of the database
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.625 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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.