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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-108-0 | CAS number: 7787-32-8
- 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:
- 2.75 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 68.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
8 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, no inhalation study available.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 135 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 688 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
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:
- no hazard identified
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:
- low hazard (no threshold derived)
Additional information - workers
According to the REACH Guidance on information requirements and chemical safety assessment, a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
Short-term toxicity
According to the REACH guideline (R8, Appendix R 8-8), a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential risk for high peak exposures. The substance is classified for acute inhalation toxicity. For short term exposure to barium fluoride, a DNEL has been derived based on the results of an acute inhalation study according to the REACH guidance. Barium fluoride is not considered to be irritating or sensitizing to the skin, while it is considered as irritating to eyes.Therefore, no local dermal DNELs need to be derived.
Long-term toxicity
Barium fluoride will dissociate under physiological conditions to form barium and fluoride ions. Since no data on the repeated dose toxicity are available for barium fluoride, the available studies with sodium fluoride and barium chloride were used to assess the systemic toxicity of Ba2 + and F- ions. For barium a relevant study (Dietz, 1992) for repeated dose toxicity, oral route performed with barium chloride dihydrate is available that results in an NOAEL of 61 mg Ba/kg bw/d which corresponds to 78 mg BaF2/kg bw/d.
For fluoride reliable repeated dose toxicity studies are available in which sodium fluoride was administered via drinking water to rats and mice for 6 months (NTP, 1990). In the rat study a NOAEL of 100 ppm NaF in the drinking water (approx. 2.8 mg fluoride/kg bw/day) was considered a NOAEL. In the mouse study a NOAEL of 10 ppm NaF in the drinking water corresponding to fluoride doses of 1.6 mg/kg bw/day was obtained for systemic toxicity in mice. This value refers to approx. 7.4 mg barium fluoride/kg bw/day.
In the absence of substance specific quantitative data on absoption, 100% absorption is assumed for the inhalation and 50% for the oral route. For the dermal route, 0.19% absorption is assumed.
Long-term DNEL inhalation, systemic effects
Based on the available repeated dose toxicity studies with barium and fluoride, the critical systemic toxic effects of barium fluoride will be due to fluoride. By comparison, long-term systemic DNELs for inhalation have been derived based both on a point-of-departure for a soluble barium substance (barium chloride) and for soluble inorganic fluorides.
Fluoride
The critical systemic effect for fluoride exposure is skeletal fluorosis. The SCOEL have recommended (1998) an IOEL value of 2.5 mg/m3 (8 -hour TWA) for inorganic fluorides (equivalent to 11.5 mg/m3 barium fluoride).
Barium
As inhalation repeated dose toxicity studies with barium fluoride are not available, route to route extrapolation was applied to derive a DNEL for the inhalation route, based on the results of a sub-chronic oral study with barium chloride in rat (Dietz, 1992) where an NOAEL of 78 mg BaF2/kg bw/day was derived.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 78 mg BaF2/kg bw/day |
A NOAEL of 61 mg Ba/kg bw/d in male rats (study performed with barium dichloride dihydrate) was identified from the 13 -week drinking water study by Dietz et al. (1992). |
Step 2) Modification of starting point |
2 0.38 m3/kg bw
6.7 m3/10 m3 |
The REACh Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 2 in case of oral to inhalation exposure. Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the REACH Guidance on information requirements and chemical safety assessment (R.8.4.2). Correction for activity driven differences of respiratory volumes in workers compared to workers in rest. |
Modified dose-descriptor |
78 x (1/2) x (1/0.38) x (6.7/10) = 68.8 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
2.5 |
No factor for allometric scaling is needed in case of inhalation exposure.A default factor of 2.5 for remaining uncertainties is used. |
Intraspecies |
5 |
Default AF for workers |
Exposure duration |
2 |
Extrapolation to chronic exposure based on a sub-chronic toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
Step 4) Calculate DNEL |
68.8 / (2.5 x 5 x 2 x 1 x 1) = 2.75 mg/m3 |
Short-term – inhalation, systemic effects
Based on the available acute inhalation toxicity study with barium fluoride in rats (Charles River, 2018).
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEC: 1000 mg/m3 |
In the acute inhalation study with barium fluoride no deaths occurred and no abnormalities were found at macroscopic examination. Therefore, 1000 mg/m3 is interpreted as a NOAEC. |
Step 2) Modification of starting point |
3√(10003x 16)
6.7/10 |
In the REACH guidance (R.8, Appendix R. 8-8), it is mentioned: ‘If a DNEL for acute toxicity needs to be established, this should be derived only for a specified fraction of the daily exposure duration (usually 15 minutes)’. The most appropriate approach is the modified Haber’s law (Cn* t = k). For extrapolation from longer to shorter durations a default value of n=3 should be used.
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3). |
Step 3) Assessment factors |
|
|
Interspecies |
2.5 |
For inhalation studies only a factor 2.5 is used, and no correction is made for differences in body size, because extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements. |
Intraspecies |
5 |
Default AF for workers |
Exposure duration |
1 |
|
Dose response |
1 |
|
Quality of database |
1 |
|
Step 4) Calculate DNEL |
3√(10003x 16) x (6.7/10) / (2.5 x 5 x 1 x 1 x 1) = 135 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.68 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 33.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
24 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, no inhalation study available.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 101 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 520 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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:
- no hazard identified
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
General population DNELs
The general population may be directly exposed to barium fluoride through some of the supported uses of the substance. The indirect exposure of the general population to barium fluoride is of limited relevance. The substance will dissociate in the environment to form fluoride and barium ions and will further interact with other ionic species naturally present in the environment. The contribution of the substance to the total fluoride intake of the general population is likely to be very small in comparison to the contribution of fluoride from natural sources, predominantly throught the diet and drinking water.
Long-term DNEL inhalation, systemic effects
Based on the available repeated dose toxicity studies with barium and fluoride, the critical systemic toxic effects of barium fluoride will be due to fluoride. By comparison, long-term systemic DNELs for inhalation have been derived based both on a point-of-departure for a soluble barium substance (barium chloride) and for soluble inorganic fluorides.
Fluoride
The critical systemic effect for fluoride exposure is skeletal and dental fluorosis. The SCOEL have recommended an IOEL value of 2.5 mg/m3 to protect against the systemic effects of fluoride exposure in workers. A systemic inhalation DNEL for the general population may be derived by the application of an assessment factor of 5 to the worker DNEL value of 2.5 mg/m3 fluoride (11.5 mg/m3 barium difluoride) to take into account the potential greater sensitivity, breathing rate (20 m3/day) and longer potential exposure period (24 hours/day) of the general population. A long-term systemic general population DNEL value of 0.5 mg/m3 fluoride is therefore calculated (equivalent to approximately 2.3 mg BaF2/m3).
Barium
As inhalation repeated dose toxicity studies with barium fluoride are not available, route to route extrapolation was applied to derive a DNEL for the inhalation route, based on the results of a sub-chronic oral study with barium chloride in rat (Dietz, 1992) where an NOAEL of 78 mg BaF2/kg bw/day was derived.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 78 mg BaF2/kg bw/day |
A NOAEL of 61 mg Ba/kg bw/d in male rats (study performed with barium dichloride dihydrate) was identified from the 13 -week drinking water study by Dietz et al. (1992). |
Step 2) Modification of starting point |
2 1.15 m3/kg bw
|
The REACh Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 2 in case of oral to inhalation exposure. Standard respiratory volume of a rat, corrected for 24 h exposure, as proposed in the REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) |
Modified dose-descriptor |
78 x (1/2) x (1/1.15) = 33.9 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
2.5 |
No factor for allometric scaling is needed in case of inhalation exposure.A default factor of 2.5 for remaining uncertainties is used. |
Intraspecies |
10 |
Default AF for general population |
Exposure duration |
2 |
Extrapolation to chronic exposure based on a sub-chronic toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
Step 4) Calculate DNEL |
33.9 / (2.5 x 10 x 2 x 1 x 1) = 0.68 mg/m3 |
Short-term – inhalation, systemic effects
Based on the available acute inhalation toxicity study with barium fluoride in rats (Charles River, 2018).
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEC: 1000 mg/m3 |
In the acute inhalation study with Barium fluoride no deaths occurred and no abnormalities were found at macroscopic examination. Therefore, 1000 mg/m3 is interpreted as a NOAEC. |
Step 2) Modification of starting point |
3√(10003x 16)
|
In the REACH guidance (R.8, Appendix R. 8-8), it is mentioned: ‘If a DNEL for acute toxicity needs to be established, this should be derived only for a specified fraction of the daily exposure duration (usually 15 minutes)’. The most appropriate approach is the modified Haber’s law (Cn* t = k). For extrapolation from longer to shorter durations a default value of n=3 should be used. |
Step 3) Assessment factors |
|
|
Interspecies |
2.5 |
For inhalation studies only a factor 2.5 is used, and no correction is made for differences in body size, because extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements. |
Intraspecies |
10 |
Default AF for general population |
Exposure duration |
1 |
|
Dose response |
1 |
|
Quality of database |
1 |
|
Step 4) Calculate DNEL |
3√(10003x 16) / (2.5 x 10 x 1 x 1 x 1) = 101 mg/m3 |
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.