Registration Dossier
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EC number: 916-899-6 | 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:
- 7.8 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 330 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 581.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NOAEC = oral NOAEL * 1/0.38 m3 kg-1 * 6.7/10
There are no quantitative oral or inhalation absorption rates available. Based on the log Pow in the range of 1.82 -3.72, the high water solubility, and the information that absorption occurs following oral exposure, absorption by the respiratory tract is likely and can be assumed to be in the same range than oral absorption. Therefore, no further factor for absorption differences oral to inhalation is introduced.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor is 1, according to ECHA Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for duration extrapolation subacute to chronic, according to ECHA Guidance.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already covered in the modification of starting point from rat oral to human inhalatory exposure, considering the differences in respiratory volume for rat and human (worker).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences, according to ECHA Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for intraspecies differences in workers, according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The default factor for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements is 1, according to ECHA Guidance.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 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:
- 1.1 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 330 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No further factors is introduced for absorption differences extrapolation oral to dermal, because it can be assumed that absorption after dermal exposure will not be higher than after oral exposure (e.g. molecular weight in a range not favourable for dermal absorption).
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor is 1, according to ECHA Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for duration extrapolation subacute to chronic, according to ECHA Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for allometric scaling rat to human, according to ECHA Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences, according to ECHA Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for intraspecies differences in workers, according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The default factor for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements is 1, according to ECHA Guidance.
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
Contact to the skin is the relevant route to be assessed for workers. Inhalation exposure is unlikely, since the vapour pressure of the substance is calculated to be negligible at ambient temperature.
In the available Combined Repeated Dose toxicity study with the Reproduction/ Developmental Toxicity Screening (OECD TG 422) with oral exposure the substance was generally well tolerated by the rats. The kidney was identified as the primary target organ with adverse effects reported in males and females given 1000 mg/kg bw (degeneration of the tubular epithelium in both sexes and tubular basophilia in males). The NOAEL was concluded to be at the next lower dose, i.e. 330 mg/kg bw. This study is used as the point of departion for a DNEL delineation, unless further data will become available (a testing proposal of an OECD TG 408 is included in this dossier).
Since only systemic advers effects were revealed in that study route to route extrapolation from oral to dermal and from oral to inhalation is possible, and is applied (for further explanations and assessment factors see DNEL endpoint-specific fields).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.9 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 330 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 287 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NOAEC = oral NOAEL * 1/1.15 m3 kg-1
There are no quantitative oral or inhalation absorption rates available. Based on the log Pow in the range of 1.82 -3.72, the high water solubility, and the information that absorption occurs following oral exposure, absorption by the respiratory tract is likely and can be assumed to be in the same range than oral absorption. Therefore, no further factor for absorption differences oral to inhalation is introduced.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor is 1, according to ECHA Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for duration extrapolation subacute to chronic, according to ECHA Guidance.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already covered in the modification of starting point from rat oral to human inhalatory exposure, considering the differences in respiratory volume for rat and human (worker).
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences, according to ECHA Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for intraspecies differences in the general population, according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The default factor for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements is 1, according to ECHA Guidance.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 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:
- 0.55 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 330 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No further factors is introduced for absorption differences extrapolation oral to dermal, because it can be assumed that absorption after dermal exposure will not be higher than after oral exposure (e.g. molecular weight in a range not favourable for dermal absorption).
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor is 1, according to ECHA Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for duration extrapolation subacute to chronic, according to ECHA Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for allometric scaling rat to human, according to ECHA Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences, according to ECHA Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for intraspecies differences in the general population, according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The default factor for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements is 1, according to ECHA Guidance.
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:
- 0.55 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 330 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor is 1, according to ECHA Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for duration extrapolation subacute to chronic, according to ECHA Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for allometric scaling rat to human, according to ECHA Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences, according to ECHA Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for intraspecies differences in the general population, according to ECHA Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The default factor for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements is 1, according to ECHA Guidance.
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
Oral ingestion and contact to the skin are the relevant routes to be assessed for the general population. Inhalation exposure is unlikely, since the vapour pressure of the substance is calculated to be negligible at ambient temperature.
In the available Combined Repeated Dose toxicity study with the Reproduction/ Developmental Toxicity Screening (OECD TG 422) with oral exposure the substance was generally well tolerated by the rats. The kidney was identified as the primary target organ with adverse effects reported in males and females given 1000 mg/kg bw (degeneration of the tubular epithelium in both sexes and tubular basophilia in males). The NOAEL was concluded to be at the next lower dose, i.e. 330 mg/kg bw. This study is used as the point of departion for a DNEL delineation, unless further data will become available (a testing proposal of an OECD TG 408 is included in this dossier).
Since only systemic advers effects were revealed in that study route to route extrapolation from oral to dermal and from oral to inhalation is possible, and is applied (for further explanations and assessment factors see DNEL endpoint-specific fields).
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.

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