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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 16.46 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 468.42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Per REACH Guidance 8.4.2 the different exposure time (7 days/week in the experiment; 5 days/week for workers) were corrected by multiplying a factor of 7/5. According to Example R. 8-2 Workers, this time correctet oral NOAEL of 1400 mg/kg/day (28 days Repeated Dose Toxicity Test) was converted to an inhalation equivalent: 1400 mg/kg/day ÷ 0.38 m3/kg bw (8 h exposure – rat) × 6.7 m³ (8 h exposure – human) ÷ 10 m³ (worker respiratory volume [wRV] - 8 h) = 2468.42 mg/m³
- AF for dose response relationship:
- 2
- Justification:
- According to REACH Guidance (R.8.4.2), in the case of oral-to-inhalation extrapolation, and in the absence of route-specific information on the starting route, a default factor of 2 should be included (i.e. the absorption percentage for the starting route is half that of the end route). The inclusion of factor of 2 means that 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation. A default factor of 2 is appropriate per REACH Guidance R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- A factor allowing for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration needs to be considered taking into account that
a) in general the experimental NOAEL will decrease with increasing exposure times and
b) other and more serious adverse effects may appear with increasing exposure times. A default factor of 6 (sub-acute to chronic exposure) is appropriate per REACH Guidance R.8.4.3.1. - Justification:
- The default allometric scaling factor of 4 (rat to human) per REACH Guidance R.8.4.3.1 is already included in the calculation of the modified dose descriptor starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- The standard procedure for threshold effects would be, as a default, to correct for differences in
metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences. A default factor of 2.5 is appropriate per REACH Guidance R.8.4.3.1. - AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the
very ill. A default factor of 5 is appropriate per REACH Guidance R.8.4.3.3.
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:
- 4.67 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Per REACH Guidance 8.4.2 the different exposure time (7 days/week in the experiment; 5 days/week for workers) were corrected by multiplying a factor of 7/5.
- AF for differences in duration of exposure:
- 6
- Justification:
- A factor allowing for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration needs to be considered taking into account that
a) in general the experimental NOAEL will decrease with increasing exposure times and
b) other and more serious adverse effects may appear with increasing exposure times. A default factor of 6 (sub-acute to chronic exposure) is appropriate per REACH Guidance R.8.4.3.1. - AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling extrapolates doses according to an overall assumption that equitoxic doses (when expressed in mg/kg bw/day) scale with body weight. A default factor of 4 (rat to human) is appropriate per REACH Guidance R.8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- The standard procedure for threshold effects would be, as a default, to correct for differences in
metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences. A default factor of 2.5 is appropriate per REACH Guidance R.8.4.3.1. - AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the
very ill. A default factor of 5 is appropriate per REACH Guidance R.8.4.3.3.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 2.9 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.57 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Per REACH Guidance 8.4.2 (Example R. 8 -1 General Public), the oral NOAEL of 1000 mg/kg/day (28 days Repeated Dose Toxicity Test) was converted to an inhalation equivalent: 1000 mg/kg/day ÷ 1.15 m3/kg bw (24 h exposure – rat) = 869.57 mg/m³.
- AF for dose response relationship:
- 2
- Justification:
- According to REACH Guidance (R.8.4.2), in the case of oral-to-inhalation extrapolation, and in the absence of route-specific information on the starting route, a default factor of 2 should be included (i.e. the absorption percentage for the starting route is half that of the end route). The inclusion of factor of 2 means that 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation. A default factor of 2 is appropriate per REACH Guidance R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- A factor allowing for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration needs to be considered taking into account that
a) in general the experimental NOAEL will decrease with increasing exposure times and
b) other and more serious adverse effects may appear with increasing exposure times. A default factor of 6 (sub-acute to chronic exposure) is appropriate per REACH Guidance R.8.4.3.1. - Justification:
- The default allometric scaling factor of 4 (rat to human) per REACH Guidance R.8.4.3.1 is already included in the calculation of the modified dose descriptor starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- The standard procedure for threshold effects would be, as a default, to correct for differences in
metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences. A default factor of 2.5 is appropriate per REACH Guidance R.8.4.3.1. - AF for intraspecies differences:
- 10
- Justification:
- For general population, as standard procedure for threshold effects a default assessment factor of 10 is to be used, based on the fact that humans differ in sensitivity to toxic insult due to a multitude of biological factors such as genetic polymorphism affecting e.g. toxicokinetics/metabolism, age, gender, health status and nutritional status. A default factor of 10 is appropriate per REACH Guidance R.8.4.3.3.
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:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for differences in duration of exposure:
- 6
- Justification:
- A factor allowing for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration needs to be considered taking into account that
a) in general the experimental NOAEL will decrease with increasing exposure times and
b) other and more serious adverse effects may appear with increasing exposure times. A default factor of 6 (sub-acute to chronic exposure) is appropriate per REACH Guidance R.8.4.3.1. - AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling extrapolates doses according to an overall assumption that equitoxic doses (when expressed in mg/kg bw/day) scale with body weight. A default factor of 4 (rat to human) is appropriate per REACH Guidance R.8.4.3.1
- AF for other interspecies differences:
- 2.5
- Justification:
- The standard procedure for threshold effects would be, as a default, to correct for differences in
metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences. A default factor of 2.5 is appropriate per REACH Guidance R.8.4.3.1. - AF for intraspecies differences:
- 10
- Justification:
- For general population, as standard procedure for threshold effects a default assessment factor of 10 is to be used, based on the fact that humans differ in sensitivity to toxic insult due to a multitude of biological factors such as genetic polymorphism affecting e.g. toxicokinetics/metabolism, age, gender, health status and nutritional status. A default factor of 10 is appropriate per REACH Guidance R.8.4.3.3.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- no hazard identified
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
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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