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Diss Factsheets
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EC number: 230-743-8 | CAS number: 7299-99-2
- 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:
- 70.52 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL for repeat dose inhalation toxicity.
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- Duration of exposure: subchronic to chronic
- Justification:
- Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference between respiratory rates of workers under standard conditions and under light activity in the second step. NAECcorr_inh = oral NOAEL (from OECD 408 study (1000 mg/kg/bw) x 1/0.38 m3/kg bw x 6.7 m3/10 m3 = 1763 mg/m3. Oral absorption in rats is assumed to be 100%. For the purposes of risk assessment, absorption in humans is also taken as 100%. Therefore, NAECcorr_inh = 1763 x 100/100 = 1763 mg/m3
- AF for intraspecies differences:
- 5
- Justification:
- intraspecies – workers
- AF for the quality of the whole database:
- 1
- Justification:
- quality of data base
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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:
- 100 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- duration of exposure: subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for intraspecies differences:
- 5
- Justification:
- intraspecies – workers
- AF for the quality of the whole database:
- 1
- Justification:
- quality of database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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
The test substance does not have any local irritating or sensitizing effects in animals. By extrapolation it is possible to calculate systemic and local DNELS for short term and some long term exposure; however calculation of long term local DNELS for local effects on the basis of the available data does not seem to be reasonable, as the substance is not classified for acute toxicological effects. The assessment factors applied for long term systemic effects are deemed to provide suitable exposure modelling for risk assessment.
The same toxicological endpoints chosen for setting the DNELs for workers have been used for setting DNELs for the general population. The increased assessment factor for interspecies sensitivity is considered sufficiently protective.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL for repeat dose inhalation toxicity.
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- duration of exposure – subchronic to chronic
- Justification:
- Corrected dose descriptor: 869.6 mg/m3 (1000 mg/kg bw/day x 1/1.15 x 1 [rat oral abs 100%/human inhalation abs 100%])
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Quality of the database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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:
- 50 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- duration of exposure – subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- quality of the database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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:
- 5 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- duration of exposure – subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- quality of database
- AF for remaining uncertainties:
- 2.5
- Justification:
- remaining differences
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
The test substance does not have any local irritating or sensitizing effects in animals. By extrapolation it is possible to calculate systemic and local DNELS for short term and some long term exposure; however calculation of long term local DNELS for local effects on the basis of the available data does not seem to be reasonable, as the substance is not classified for acute toxicological effects. The assessment factors applied for long term systemic effects are deemed to provide suitable exposure modelling for risk assessment.
The same toxicological endpoints chosen for setting the DNELs for workers have been used for setting DNELs for the general population. The increased assessment factor for interspecies sensitivity is considered sufficiently protective.
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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