Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 222-079-2 | CAS number: 3338-24-7
- 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:
- 29.6 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 741 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to "ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health" (Version 2.1, November 2012), and "ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14" (Version 1, July 2012).
The calculation of the DNEL is based on an oral NOAEL observed in a subchronic toxicity study in rats (OECD 408). To convert the rat oral NOAEL into an inhalation NOAEC to assess human exposure via the inhalation route, the NOAEL has to be corrected as follows:
Corrected inhal NOAEC = NOAEL(oral) × (1 / sRVrat) × (ABSoral-rat / ABSinh-human) × (sRVhuman / wRV) × (Fstudy / Fworker)
= 600 mg/kg bw/day × (1 / 0.38 m³/kg bw/day) × (1 / 2) × (6.7 m³ / 10 m³) × (7 / 5) = 741 mg/m³
sRV = standard respiratory volume; wRV = respiratory volume light activity for worker (8 h); ABS = absorption; Fstudy = frequency of exposure in study (days per week); Fworker = frequency of exposure worker (days per week)
The NOAEL was corrected for interspecies difference between rat and human as well as for the differences in the experimental and human exposure conditions. The animals (rats) were exposed to the test substance 7 days/week; whereas workers are in general exposed 5 days/week (factor 7 days/5 days), this correction factor is included according to IUCLID 6.4 DNEL calculator.
As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption.
Thus, the corrected starting point for workers is 741 mg/m³ for inhalation.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study (subchronic to chronic).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not applicable for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences according to ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for Worker according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL based on reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.4 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 840 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for dermal effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to "ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health" (Version 2.1, November 2012), and "ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14" (Version 1, July 2012).
The calculation of the DNEL is based on an oral NOAEL observed in a subchronic toxicity study in rats (OECD 408). To convert the rat oral NOAEL into a dermal NOAEL to assess human exposure via the dermal route, the NOAEL has to be corrected as follows:
Corrected dermal NOAEL = NOAEL(oral) × (ABSoral-rat / ABSdermal-human) × (Fstudy / Fworker)
= 600 mg/kg bw/day × (1 / 1) × (7 / 5)= 840 mg/kg bw/day
ABS = absorption; Fstudy = frequency of exposure in study (days per week); Fworker = frequency of exposure worker (days per week).
The animals (rats) were exposed to the test substance 7 days/week; whereas workers are in general exposed 5 days/week (factor 7 days/5 days), this correction factor is included according to IUCLID 6.4 DNEL calculator.
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor is introduced.
Thus, the corrected starting point for workers is 840 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study (subchronic to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat to human according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.22 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic inhalative effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to "ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health" (Version 2.1, November 2012), and "ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14" (Version 1, July 2012).
The calculation of the DNEL is based on an oral NOAEL observed in a subchronic toxicity study in rats (OECD 408). To convert the rat oral NOAEL into an inhalation NOAEC to assess human exposure via the inhalation route, the NOAEL has to be corrected as follows:
Corrected inhal NOAEC = NOAEL(oral) × (1 / sRVrat) × (ABSoral-rat / ABSinh-human)
= 600 mg/kg bw/day × (1 / 1.15 m³/kg bw/day) × (1 / 2) = 261 mg/m³
sRV = standard respiratory volume; ABS = absorption
The NOAEL was corrected for interspecies difference between rat and human. As worst case as recommended in the ECHA Guidance R.8 (2012), it is assumed that oral absorption rate is 50% of that of inhalation absorption.
Thus, the corrected starting point for the general population is 261 mg/m³ for inhalation.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study (subchronic to chronic).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not applicable for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for General population according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for dermal effects was estimated via route-to-route-extrapolation and assessment factors were applied, all according to "ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health" (Version 2.1, November 2012), and "ECHA: How to prepare toxicological summaries in IUCLID and how to derive DNELs Practical Guide 14" (Version 1, July 2012).
The calculation of the DNEL is based on an oral NOAEL observed in a subchronic toxicity study in rats (OECD 408). To convert the rat oral NOAEL into a dermal NOAEL to assess human exposure via the dermal route, the NOAEL has to be corrected as follows:
Corrected dermal NOAEL = NOAEL(oral) × (ABSoral-rat / ABSdermal-human)
= 600 mg/kg bw/day × (1 / 1) =600 mg/kg bw/day
ABS = absorption;
On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor is introduced.
Thus, the corrected starting point for the general population is 600 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on subchronic study (subchronic to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat to human according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation is needed.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study (subchronic to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences according to ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on reliable study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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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