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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 801-773-4 | CAS number: 1550-44-3
- 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:
- 1.03 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:
- 51 mg/m³
- Modified dose descriptor starting point:
- other: Corrected NOAEC (after corrections to account for time scaling and differences in respiratory volumes)
- Value:
- 25.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Two modifications needed to be applied to calculate the correct starting point. Firstly, time scaling was required in order to extrapolate from exposure conditions used for experimental animals (exposed 6h/d and 5 d/wk) to exposure conditions for workers (exposed 8h/d and 5 d/wk). Secondly, it was required to account for the differences in respiratory volumes between experimental animals (6.7 m3 at rest) and humans (10 m3 under light activity). Applying these two modifications to the critical dose descriptor (i.e. NOAEC = 51 mg/m3) gives a starting point of 25.63 mg/m3 (= 51 x [6/8] x [6.7/10]).
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), an AF of 1 was applied for dose-response relationship because the critical dose descriptor is a NOAEC.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), an AF of 2 was applied for differences in duration of exposure in order to extrapolate from sub-chronic (i.e. 90-day study) to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), allometric scaling should not be applied in cases where doses in experimental animal studies are expressed as concentrations (e.g., in mg/m3 in air, ppm in diet, or mg/l in the drinking water) as these are assumed to be already scaled according to the allometric principle, since ventilation rate and food intake directly depend on the basal metabolic rate. Here, the critical dose descriptor used as a basis for the DNEL derivation comes from a repeated dose toxicity study by inhalation and is expressed in ppm or mg/m3 in air. The AF for interspecies differences (allometric scaling) was thus set equal to 1.
- AF for other interspecies differences:
- 2.5
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), an AF of 2.5 was applied to account for other interspecies (i.e. other than related to allometric scaling) differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part).
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), as standard procedure, a default AF of 5 was applied for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The information available in the total toxicological database meets the tonnage driven data REACH requirements. In addition, the available data, all obtained from experimental GLP-compliant studies performed according to internationally recognized guidelines, are reliable and consistent. In accordance with ECHA Guidance R.8 (version 2.1, November 2012), an AF of 1 was thus applied for the quality of the whole database.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional AF was applied. For instance, the considered systemic effects (i.e. body weight reduction, decrease in blood glucose, and increase in urine ketones) are not among the severe effects for which an additional assessment factor could be required (i.e. respiratory sensitization, teratogenicity/developmental effects, reproductive or threshold carcinogenic effects).
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.56 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
- Value:
- 506 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), an AF of 1 was applied for dose-response relationship because the critical dose descriptor is a NOAEC.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012) when dealing with local tissue damage in the respiratory tract resulting from exposure by inhalation, an AF of 2 was applied for differences in duration of exposure in order to extrapolate from sub-chronic (i.e. 90-day study) to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, as it is the case of local effects like the one considered here (i.e. local effects on the olfactory epithelium). In the present case, the corresponding AF was thus set equal to 1.
- AF for other interspecies differences:
- 2.5
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012) and given that there could be significant quantitative differences in deposition, airflow patterns, clearance rates and protective mechanisms between humans and animals, it was assumed that humans could be more sensitive than animals to effects on the respiratory tract. As a consequence, an AF of 2.5 was applied to account for other interspecies (i.e. other than related to allometric scaling) differences.
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECHA Guidance R.8 (version 2.1, November 2012), as standard procedure, a default AF of 5 was applied for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The information available in the total toxicological database meets the tonnage driven data REACH requirements. In addition, the available data, all obtained from experimental GLP-compliant studies performed according to internationally recognized guidelines, are reliable and consistent. In accordance with ECHA Guidance R.8 (version 2.1, November 2012), an AF of 1 was thus applied for the quality of the whole database.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional AF was applied. For instance, the considered effect (i.e. local effects on the olfactory epithelium) is not among the severe effects for which an additional assessment factor could be required (i.e. respiratory sensitization, teratogenicity/developmental effects, reproductive or threshold carcinogenic effects).
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:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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:
- 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
- There is no consumer uses for DFEA, implying that there is no need to assess exposure of consumers and thus no need to derive a DNEL for general population on this basis.
- There is no direct release of DFEA in the environment. In addition, ECHA Guidance R.16 (section R.16.1.3.2. page 25, version 3.0, February 2016) indicates that an assessment of indirect exposure of humans via the environment is generally only conducted if:
- the tonnage >1000 t/y or
- the tonnage >100 t/Y and the substance is classified
- as STOT RE 1; or
- as a carcinogen or mutagen (any category); or
- as toxic to reproduction (categories 1A or 1B).
The general population includes consumers and humans exposed via the environment:
DFEA does not comply with the above criteria, implying that there is no need to assess exposure of man via the environment and thus no need to derive a DNEL for general population on this basis.
As a result, no DNEL for the general population was derived for DFEA.
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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