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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-003-4 | CAS number: 1415316-96-9
- 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:
- 5.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 270 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 136 mg/m³
- Explanation for the modification of the dose descriptor starting point:
corrected for exposure duration (6h => 8h), higher respiration rate during activity (6.7m³ => 10m³ in 8h)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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:
- 1.94 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 582 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL => NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic => chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The LOAEL from the 90 -day dermal study was selected as starting point for the systemic long term DNEL. For comparison, the same calculation (excluding the factor of 3 for extrapolating from LOAEL to NOAEL) was performed using the NOAEL of app. 236mg/kg from the EOGRTS as starting point. This results in a very similar DNEL of 2.36mg/kg.
Though effects on reproductive parameters were observed in the EOGRTS, their relevance for human health are still unclear. Nevertheless, they occur at higher concentrations than the effects on blood, liver and kidneys, leading to a NOAEL of app. 360mg/kg. Consequently, the derived DNEL based on effects on blood, liver and kidney is also protective against any potential developmental effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.96 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 270 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 48.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
corrected for exposure duration (6h => 24h), exposure days (5 days => 7 days)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC used
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default factor for consumer
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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:
- 0.97 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- LOAEL
- Value:
- 582 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL => NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic => chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default for consumers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 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:
- 236 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic => chronic (test duration in EOGRTS was app. 90 days)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
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 LOAEL from the 90 -day dermal study was selected as starting point for the systemic long term DNEL. For comparison, the same calculation (excluding the factor of 3 for extrapolating from LOAEL to NOAEL) was performed using the NOAEL of app. 236mg/kg from the EOGRTS as starting point. This results in a very similar DNEL of 1.2mg/kg.
Though effects on reproductive parameters were observed in the EOGRTS, their relevance for human health are still unclear. Nevertheless, they occur at higher concentrations than the effects on blood, liver and kidneys, leading to a NOAEL of app. 360mg/kg. Consequently, the derived DNEL based on effects on blood, liver and kidney is also protective against any potential developmental effects.
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.