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Diss Factsheets
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EC number: 603-073-2 | CAS number: 12549-23-4
- 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:
- 3.5 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:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Extrapolation from an oral subacute study to workers' inhalation route. The inhalatory absorption rate for the substance has been estimated to be 10 %, based on the fact that the substance is highly insoluble in water with a molecular weight of 349, has a very low vapour pressure (< 1.2 x 10^-9 Pa) and a large particle size (1.05% of particles <100 µm).
NOAECcorr=NOAELoral*(1/0.38 m³/kg/d)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 30 mg/kg/d*(1/0.38 m³/kg/d)*(0.5/0.1)*0.67=264,5 mg/m³.
It is assumed that oral absorption rate is 50% of that of inhalation absorption. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL to inhalatory NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on an oral subacute study: assessment factor for subacute to chronic applied
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not used for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for other interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers' intraspecies differences
- AF for the quality of the whole database:
- 1
- Justification:
- The study has a Klimisch score = 1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEC
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Extrapolation of an oral repeated dose NOAEL from a subacute study on rats to a worker's dermal NOAEC.
The dermal absorption rate for the substance has been estimated to be 10 %, based on the fact that the substance is highly insoluble in water and has a large particle size (1.05% of particles <100 µm), with a molecular weight of 349. The dermal LD50 for the substance is >2000 mg/kg and there were no acute systemic effects after dermal exposure. Results for skin corrosion, irritation and sensitization were negative.
Dermal NOAEC=oral NOAEL*(ABSoral-rat/ABSdermal-human)=30 mg/kg bw/day*10
It is normally assumed that oral and dermal absorption rates are equal. However, in this case the dermal absorption rate for the substance has been estimated to be 10 %.
- AF for dose response relationship:
- 1
- Justification:
- Oral NOAEL to dermal NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to compensate differences in metabolic rate/body weight in rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for other interspecies differences in accordance with ECHA Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers' intraspecies differences
- AF for the quality of the whole database:
- 1
- Justification:
- The study has a Klimisch score = 1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance is only marketed for industrial use and is therefore not handled by the general population. Downstream use takes place at nuclear facilities or equivalent sites that are closed, highly controlled environments. Waste from the production site is minimised and recovered for production or treated as hazardous waste. Any waste produced during downstream use is treated as radioactive or as hazardous waste. Due to the adopted risk management measures at the production site, such as ventilation exhaust air filters, and those recommended to the downstream users, the emissions of the substance to the environment are negligible, eliminating the exposure to the substance through the environment. Therefore, exposure to the substance by the general population is unlikely irrespective of exposure route.
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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