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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 477-700-1 | CAS number: 883794-93-2
- 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:
- 2.35 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.32 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data are available for the inhalation route. However, reliable data are available for the oral route.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default (not applied for inhalation route)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default (worker)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.67 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No data are available for the dermal route. However, reliable data are available for the oral route.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default (worker)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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 28-day oral NOAEL for the substance was determined to be 200 mg/kg bw/day, based on weight of evidence. The NOAEL was based on increase of kidney weight associated with histopathological changes in high dose females (1000 mg/kg bw/day) at the end of the recovery period. The kidney weight at the end of recovery period was of lower statistical significance when compared with the end of dosing period. This is an indication for reversibility of kidney weight change also in female animals. No data on reproductive or developmental toxicity are available.
The substance is not acutely harmful by the oral and dermal routes, not irritating to skin or eyes and not sensitising.
The substance has no local effects.
Inhalation DNEL – worker – long term - systemic effects:
The DNEL for systemic effects via the inhalation route is determined on the basis of route-to-route extrapolation from 28-day oral data which had NOAEL = 200 mg/kg bw/day.
The following corrections were made to the NOAEL (oral) to derive the NOAEC (inhalation): Assessment factor for route-to-route extrapolation (oral to inhalation): 2 (ECHA default)
Correction for respiratory rate and volume (rat to human worker): (6.7 m³/d / 10 m³/d) * (1 / 0.38 m³/kg) (ECHA default).
Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is:
100 mg/kg/day * (6.7 m³/d / 10 m³/d)*(1 / 0.38 m³/kg) = 176.32 mg/m³.
The following assessment factors were applied to the corrected NOAEC:
Assessment factor for extrapolation of exposure duration (sub-acute to chronic): 6 (ECHA default)
Assessment factor for allometric scaling: 1 (ECHA default, not applied for inhalation route)
Assessment factor for other interspecies differences: 2.5 (ECHA default);
Assessment factor for intraspecies differences: 5 (ECHA default, worker).
The overall Assessment factor is therefore: 6 * 1 * 2.5 * 5 = 75
The overall DNEL (repeated-dose – systemic – inhalation - worker)is therefore 176.32 mg/m³ / 75 = 2.35 mg/m³.
Dermal DNEL – worker – long term - systemic effects:
The DNEL for systemic effects via the dermal route is determined on the basis of route-to route extrapolation from 28-day oral data, which had NOAEL = 200 mg/kg bw/day.
The following correction was made to the NOAEL:
Assessment factor for route-to-route extrapolation (oral to dermal): 1 (ECHA default)
The corrected NOAEL for the dermal route is therefore: 200 mg/kg bw/day /1 = 200 mg/kg bw/day.
The assessment factors used to determine the DNELs for repeated dose toxicity were selected on the following basis:
Assessment factor for extrapolation of exposure duration (sub-acute to chronic) has been used: 6 (ECHA default)
Assessment factor for allometric scaling (rat to human): 4 (ECHA default)
Assessment factor for other interspecies differences: 2.5 (ECHA default)
Assessment factor for intraspecies differences: 5 (ECHA default, worker)
The overall Assessment factor is therefore: 6 * 4 * 2.5 * 5 = 300
The overall DNEL (repeated-dose – systemic – dermal - worker) is therefore 200 mg/kg bw/day / 300 = 0.67 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default (general population)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There is no consumer exposure to the substance as it is not present in products used by the general population. However, an oral DNEL for the general population is needed for the assessment of exposure to man via the environment.
The 28-day oral NOAEL for the substance was determined to be 200 mg/kg bw/day, based on weight of evidence. The NOAEL was based on increase of kidney weight associated with histopathological changes in high dose females (1000 mg/kg bw/day) at the end of the recovery period. The kidney weight at the end of recovery period was of lower statistical significance when compared with the end of dosing period. This is an indication for reversibility of kidney weight change also in female animals. No data on reproductive or developmental toxicity are available.
The substance is not acutely harmful by the oral and dermal routes, not irritating to skin or eyes and not sensitising.
The substance has no local effects.
Oral DNEL – general population – long term - systemic effects:
The DNEL for systemic effects via the oral route is determined from 28-day oral data which had NOAEL = 200 mg/kg bw/day.
No corrections were made to the NOAEL; therefore, the dose descriptor starting point is 200 mg/kg bw/day.
The following assessment factors were applied to the corrected NOAEL:
Assessment factor for extrapolation of exposure duration (sub-acute to chronic): 6 (ECHA default)
Assessment factor for allometric scaling: 4 (ECHA default, rat to human)
Assessment factor for other interspecies differences: 2.5 (ECHA default);
Assessment factor for intraspecies differences: 10 (ECHA default, general population).
The overall Assessment factor is therefore: 6 * 4 * 2.5 * 10 = 600
The overall DNEL (repeated-dose – systemic – oral – general population) is therefore 200 mg/kg bw/day / 600 = 0.33 mg/kg bw/day.
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.