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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- 23.4 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:
- 996 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 756 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No data available on inhalation route; therefore DNEL should be derived from an oral route study.
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- 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:
- 3.32 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:
- 996 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 996 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data available on dermal route; therefore DNEL should be derived from an oral route study.
Default dermal absorption value of 100%
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.77 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:
- 996 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 866 mg/m³
- Explanation for the modification of the dose descriptor starting point:
See discusion.
- AF for dose response relationship:
- 1
- Justification:
- Starting point = NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- 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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.66 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:
- 996 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 996 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data available on dermal route; therefore DNEL should be derived from an oral route study.
Default dermal absorption value of 100%
- AF for dose response relationship:
- 1
- Justification:
- Starting point= NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.66 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:
- 996 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 996 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point= NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
- AF for remaining uncertainties:
- 1
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
A.- ACUTE TOXICITY. Systemic effects
Oral exposure
Since the substance is not classified for oral acute exposure, no DNEL for acute systemic effects is to be derived.
Dermal exposure. Systemic effects
Since the substance is not classified for dermal acute exposure, no DNEL for acute systemic effects is to be derived.
Inhalatory exposure
Since the substance is not classified for inhalation acute exposure, no DNEL for acute systemic effects is to be derived.
B.- IRRITATION/ CORROSION
The substance is not irritating or corrosive.
C.- SENSITIZATION
The substance does not exhibited experimental evidence of sensitizing potential.
D.- MUTAGENICITY/ CARCINOGENICITY
There were no indications of a possible non-threshold mutagenic or tumorigenic response by any exposure route and the experimental results show no positive responses for in vitro mutagenicity assays. Therefore DNELs have not been established either for carcinogenicity nor mutagenicity.
E.- REPEAT DOSE TOXICITY:Systemic effects
Duration differences (the assessment factor for extrapolation from subacute to chronic exposure) is set in the REACH guidance as AF = 6. It is applied in this case because the dose descriptor is derived from a sub-chronic exposure study and the DNEL is for long term exposure.
Dose-response related issues
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
Quality of whole database
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Dermal exposure
Since no dose descriptor was available from a repeated application dermal toxicity study and dermal exposure is the most probable route of human exposure, it was necessary to derive a corrected dermal NOAEL from the oral NOAEL. The oral dose descriptor was used as the basis for route-to-route extrapolation.
Dermal risk assessment is based on the oral NOAEL of 996 mg/kg/day from the 28 -day rat study.
Taking into account a default dermal absorption value of 100% the NOAEL of 996 mg/kg/day is used as the starting point for the dermal route.
The following adjustment factors are applied for the identification of the reference MOS:
(1) for duration adjustment a factor of 6 is used;
(2) the allometric scaling factor for the rat is 4;
(3) a default factor of 2.5 accounts for additional interspecies differences;
(4) for intraspecies differences the default factor is 5 for workers and for consumers is 10
Applying these factors to the oral NOAEL gives:
DNEL dermal, systemic, chronic worker = 996/300 = 3.32 mg/kg bw/day
DNEL dermal, systemic, chronic consumers= 996/600 = 1.66 mg/kg bw/day
Oral exposure
Starting point is NOAEL of 996 mg/kg/day from a 28 -day rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:
DNEL oral, systemic, chronic general population = 996/600= 1.66 mg/kg/day
No oral exposure is considered for workers.
Inhalatory exposure
For the chronic inhalation exposure DNELs, the corrected NOAEL was derived as a starting point based on the oral NOAEL of 996 mg/kg bw/day, since no study data were available from long term repeated exposure investigations via the inhalation route. This route is considered of minor concern due to the vapour pressure of the substance.
The total assessment factor for the worker population, long term DNEL inhalation, systemic = 6*2.5*5*1*1 = 75 when the subacute to chronic factor is included.
The total assessment factor for the general population, long term DNEL inhalation, systemic = 6*2.5*10*1*1 = 150 when the subacute to chronic factor is included.
Differences in respiration volumes were assessed for converting the oral dose to an inhalation concentration:
Worker Population - NOAEL of 996 mg/kg/d /0.38m3/kg = 2621 * [6.7 m3/ 10 m3] = 1756 mg/m3.
General Population - NOAEL of 996 mg/kg/d /1.15m3/kg = 866 mg/m3
Applying the above explained AF:
DNEL inhalation, systemic, chronic worker population = 1756 / 75 = 23.4 mg/m3
DNEL inhalation, systemic, chronic general population = 866 / 150 = 5.77 mg/m3
The default absorption percentage 100%, for inhalation has also been used in the calculations.
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.
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