Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 211-792-4 | CAS number: 696-29-7
- 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:
- 32.4 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:
- 1 610 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 809 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Conversion of an rat NOAECinhalatory; rep. dosefrom 90 day rat inhalativ repeated dose toxicity study into an corrected NOAECinhalatory; rep. dose (derived from figure R.8-2; Chapter R 8.4.2 of TGD “Chapter R.8: Characterisation of dose [concentration]-response for human health”):
For workers:
assumptions:
8 h exposure/day
Inhalation absorption rat = inhalation absorption human
corrected NOAECinhalatory; rep.dose = rat NOAECinhalatory; rep. dose* ((6 h/d) / (8 h/d)) * ((6.7 m3 (8h)) / 10 m3 (8h))
= 1610 mg/m3* 0.75 * 0.67
= 809 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor 1, because the starting point is a NOAEC, Chapter R 8.4.3.1 of ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- According to Chapter R.8 of ECHA REACH Guidance, Table 8-5 the default assessment factor for subchronic to chronic duration is 2.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- For an inhalation study already scaled according to the allometric principle, Chapter R 8.4.3.1 of ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor for remaining interspecies differences in case for systemic effects, Chapter R 8.4.3.1 of ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor for workers, Chapter 8.4.3.1 of ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor for good quality of the database, Chapter 8.4.3.1 of ECHA REACG Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 32.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.1 mg/kg bw/day
- 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 809 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Converting the inhalatory NOAEL rat into a dermal NOAEL is necessary to derive the correct starting point for the
dermal route for which no long term study was carried out.
Conversion of an rat NOAELinhal; rep. dosefrom 90 day rat inhalative repeated dose toxicity study into an corrected NOAELderm; rep.dose (derived from examples B.4 and B.5; Appendix R 8-2 of TGD “Chapter R.8: Characterisation of dose [concentration]-response for human health”):
For worker:
assumptions:
- No default factor for absorption should be introduced (i.e. factor 1) in case of inhalation-to-oral extrapolation according to Chapter R.8.4.2 of TGD)
- On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor for absorption should be introduced when performing oral-to-dermal extrapolation according to Chapter R.8.4.2 of TGD).
corrected NOAELoral; rep. dose = corrNOAELinhal; rep.dose * sRVrat * (ABSinhal-rat/ABSoral-human)
= 809 mg/m3 * 0.38 m3/kg bw * 1
= 307 mg/kg bw
corrected NOAELderm; rep.dose= corrNOAELoral; rep. dose* (ABSoral/ ABSderm)
= 307 mg/kg bw day * 1
= 307 mg/kg bw day
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
- AF for differences in duration of exposure:
- 2
- Justification:
- A assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic to chronic (see section R 8.4.3.1, Table R.8-5) (ECHA, Nov. 2012).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov. 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov. 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 8.05 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):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 1 610 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 402.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No route-to-route-extrapolation is needed
Conversion of an rat NOAECinhalatory; rep. dosefrom 90 day rat inhalativ repeated dose toxicity study into an corrected NOAECinhalatory; rep. dose for general population (derived from figure R.8-2; Chapter R 8.4.2 of TGD “Chapter R.8: Characterisation of dose [concentration]-response for human health”):
For general population:
assumptions:
24 h exposure/day
Inhalation absorption rat = inhalation absorption human
corrected NOAECinhalatory; rep.dose = rat NOAECinhalatory; rep. dose* ((6 h/d) / (24 h/d))
= 1610 mg/m3* 0.25
= 402.5 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEC. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of ECHA TGD (ECHA, Nov. 2012).
- AF for differences in duration of exposure:
- 2
- Justification:
- According to Chapter R.8 of ECHA REACH Guidance, Table 8-5 the default assessment factor for subchronic to chronic duration is 2.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to ECHA TGD (ECHA, Nov. 2012) an allometric scaling factor is not applicable when setting an inhalation DNEL based on an inhalation animal study (see Appendix R.8-2), therefore AF 1 is chosen.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability, the default assessment factor for general population for systemic effects is 10 (ECHA, Nov. 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of ECHA TGD (ECHA, Nov. 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL extrapolated from long term DNEL
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route-extrapolation needed
Conversion of an rat NOAELoral; rep. dosefrom developmental toxicity study into an humanNOAELoral; rep. dose (derived from example A.1; Appendix R 8-2 of TGD “Chapter R.8: Characterisation of dose [concentration]-response for human health”):
For general population:
assumptions:
absorptionoral-rat= absorptionoral-human
human NOAELoral; rep.dose= rat NOAELoral; rep. dose = 300 mg/kg bw day
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEC. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- A assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute to chronic (see section R 8.4.3.1, Table R.8-5) (ECHA, Nov. 2012).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov. 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability, the default assessment factor for the general population is 10 (ECHA, Nov. 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
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.