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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 249-277-1 | CAS number: 28874-51-3
- 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:
- 141 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to inhalation NOAEC: 1000 mg/kg/day x [1/0.38 x 100/100 x 6.7/10] = 1763 mg/m3
- AF for differences in duration of exposure:
- 1
- Justification:
- Although the duration of the OECD 421 study from which the starting point (NOAEL/NOEL 1000 mg/kg bw/day) was obtained is generally considered sub-acute, treatment for up to 6 months at the extremely high dosage of 7200 mg/kg bw/day resulted in no adverse effects but only adaptive changes in kidneys. On this basis it is considered appropriate to not apply any AF for duration of exposure at the much lower limit dose of 1000 mg/kg bw/day chosen as the worst-case starting point
- Justification:
- Not applicable for inhalation (differences in species addressed in calculation of dose descriptor starting point).
- AF for other interspecies differences:
- 2.5
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point.
- AF for intraspecies differences:
- 5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for the tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 000 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to dermal NOAEL: 1000 mg/kg/day x [oral absorption 100% / dermal absorption 1%] = 100000 mg/kg/day
- AF for differences in duration of exposure:
- 1
- Justification:
- Although the duration of the OECD 421 study from which the starting point (NOAEL/NOEL 1000 mg/kg bw/day) was obtained is generally considered sub-acute, treatment for up to 6 months at the extremely high dosage of 7200 mg/kg bw/day resulted in no adverse effects but only adaptive changes in kidneys. On this basis it is considered appropriate to not apply any AF for duration of exposure at the much lower limit dose of 1000 mg/kg bw/day chosen as the worst-case starting point.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for other interspecies differences:
- 2.5
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point.
- AF for intraspecies differences:
- 5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for the tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
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:
- no hazard identified
Additional information - workers
The substance is not acutely toxic following oral administration or dermal application and therefore acute DNELs for systemic effects are not required. The substance was not irritating either to the skin or eye and did not show any sensitising potential therefore DNELs for local effects are not required.
Based on the available studies used to support the registration, the substance is considered to not be genotoxic.
Treatment for up to 6 months at dosages as high as 7200 mg/kg bw/day resulted in no over toxicity and only in adaptive changes of the kidney to the constant high load of sodium. Similarly, no adverse effects were observed for any of the parameters examined in a fully compliant OECD 421 study, and the NOAEL for parental systemic toxicity, and reproductive and developmental toxicity was the set at the limit dose of 1000 mg/kg bw/day.
This value was chosen as the more appropriate starting point for systemic DNELs calculation however, as the longer-term studies demonstrated that increasing the exposure duration at extremely high doses does not increase the incidence or severity of adverse effects, an assessment factor of 1 has been applied to this lower NOAEL for duration of exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to inhalation NOAEC: 1000 mg/kg/day x [1/1.15 x 100/100] = 870 mg/m3
- AF for differences in duration of exposure:
- 1
- Justification:
- Although the duration of the OECD 421 study from which the starting point (NOAEL/NOEL 1000 mg/kg bw/day) was obtained is generally considered sub-acute, treatment for up to 6 months at the extremely high dosage of 7200 mg/kg bw/day resulted in no adverse effects but only adaptive changes in kidneys. On this basis it is considered appropriate to not apply any AF for duration of exposure at the much lower limit dose of 1000 mg/kg bw/day chosen as the worst-case starting point.
- Justification:
- Not applicable for inhalation (differences in species addressed in calculation of dose descriptor starting point).
- AF for other interspecies differences:
- 2.5
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point.
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for the tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 000 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to dermal NOAEL: 1000 mg/kg/day x [oral absorption 100% / dermal absorption 1%] = 100000 mg/kg/day
- AF for differences in duration of exposure:
- 1
- Justification:
- Although the duration of the OECD 421 study from which the starting point (NOAEL/NOEL 1000 mg/kg bw/day) was obtained is generally considered sub-acute, treatment for up to 6 months at the extremely high dosage of 7200 mg/kg bw/day resulted in no adverse effects but only adaptive changes in kidneys. On this basis it is considered appropriate to not apply any AF for duration of exposure at the much lower limit dose of 1000 mg/kg bw/day chosen as the worst-case starting point.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for other interspecies differences:
- 2.5
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point.
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for the tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
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:
- 10 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for differences in duration of exposure:
- 1
- Justification:
- Although the duration of the OECD 421 study from which the starting point (NOAEL/NOEL 1000 mg/kg bw/day) was obtained is generally considered sub-acute, treatment for up to 6 months at the extremely high dosage of 7200 mg/kg bw/day resulted in no adverse effects but only adaptive changes in kidneys. On this basis it is considered appropriate to not apply any AF for duration of exposure at the much lower limit dose of 1000 mg/kg bw/day chosen as the worst-case starting point.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for other interspecies differences:
- 2.5
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point.
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for the quality of the whole database:
- 1
- Justification:
- Database appropriate for the tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance is not acutely toxic following oral administration or dermal application and therefore acute DNELs for systemic effects are not required. The substance was not irritating either to the skin or eye and did not show any sensitising potential therefore DNELs for local effects are not required.
Based on the available studies used to support the registration, the substance is considered to not be genotoxic.
Treatment for up to 6 months at dosages as high as 7200 mg/kg bw/day resulted in no over toxicity and only in adaptive changes of the kidney to the constant high load of sodium. Similarly, no adverse effects were observed for any of the parameters examined in a fully compliant OECD 421 study, and the NOAEL for parental systemic toxicity, and reproductive and developmental toxicity was the set at the limit dose of 1000 mg/kg bw/day.
This value was chosen as the more appropriate starting point for systemic DNELs calculation however, as the longer-term studies demonstrated that increasing the exposure duration at extremely high doses does not increase the incidence or severity of adverse effects, an assessment factor of 1 has been applied to this lower NOAEL for duration of exposure.
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.