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EC number: 305-871-3 | CAS number: 95193-59-2
- 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:
- 49 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Guidance on Assessment Factors to derive DNELs (2010)
- Overall assessment factor (AF):
- 18
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 50/100 = 500 mg/kg bw/day; Corrected inhalatory NOAEC = 500 mg/kg bw/day*(1/0.38 m3/kg/d)*(6.7 m3/10 m3) = 881.6 mg/m3 [8h exposure/day]
- AF for dose response relationship:
- 1
- Justification:
- Default, as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- To correct for difference in study duration and actual exposure situation (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, is taken into account in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Default according to ECETOC guidance
- AF for intraspecies differences:
- 3
- Justification:
- Default according to ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- All studies listed in REACH Annex VII and REACH Annex VIII have been conducted
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 69.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Guidance on Assessment Factors to derive DNELs (2010)
- Overall assessment factor (AF):
- 72
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSdermal-human = 1000 * 50/10 = 5000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default, as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- To correct for difference in study duration and actual exposure situation (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- To correct for metabolic rate
- AF for other interspecies differences:
- 1
- Justification:
- Default according to ECETOC guidance
- AF for intraspecies differences:
- 3
- Justification:
- Default according to ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- All studies listed in REACH Annex VII and REACH Annex VIII have been conducted
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Long-term – inhalation, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for. A certified toxicologist assessed the toxicokinetic behaviour of the substance (in accordance with Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance) and concluded:
For risk assessment purposes:
Absorption oral = 50%
Absorption dermal = 10%
Absorption inhalation = 100%
Assessment factors
The assessment factors (AFs) that are applied to obtain the endpoint-specific DNELs for the relevant exposure pattern are based on the ECETOC report “Guidance on assessment factors to derive DNELs” (final draft). In the following overview the relevant AFs are shown:
Aspect |
Assessment Factor (AF) |
Interspecies extrapolation (rat to human), for the dermal and oral route (inhalation route: not applicable) |
4 (to correct for metabolic rate)
|
Intraspecies extrapolation; worker |
3 |
Intraspecies extrapolation; general population |
5 |
Exposure duration (sub-acute to chronic) |
6 (to correct for difference in study duration and actual exposure situation) |
Dose-response |
1 (default, as the starting point is a NOAEL) |
Quality of whole database |
1 (all studies listed in REACH Annex VII and REACH Annex VIII have been conducted) |
Leading to the following Assessment Factors:
|
Assessment Factor |
|
DNEL |
Worker |
General population |
Long-term – dermal, systemic effects |
72 |
120 |
Long-term – inhalation, systemic effects (and acute – inhalation, systemic effects) |
18 |
30 |
Long-term – oral, systemic effects |
Not relevant |
120 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Guidance on Assessment Factors to derive DNELs (2010)
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 50/100 = 500 mg/kg bw day; Corrected inhalatory NOAEC = 500 mg/kg bw/day*(1/1.15 m3/kg/d) = 434.8 mg/m3 [24h exposure/day]
- AF for dose response relationship:
- 1
- Justification:
- Default, as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- To correct for difference in study duration and actual exposure situation (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, is taken into account in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Default according to ECETOC guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default according to ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- All studies listed in REACH Annex VII and REACH Annex VIII have been conducted
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 41.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Guidance on Assessment Factors to derive DNELs (2010)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSdermal-human = 1000 * 50/10 = 5000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default, as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- To correct for difference in study duration and actual exposure situation (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- To correct for metabolic rate
- AF for other interspecies differences:
- 1
- Justification:
- Default according to ECETOC guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default according to ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- All studies listed in REACH Annex VII and REACH Annex VIII have been conducted
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Guidance on Assessment Factors to derive DNELs (2010)
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default, as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- To correct for difference in study duration and actual exposure situation (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- To correct for metabolic rate
- AF for other interspecies differences:
- 1
- Justification:
- Default according to ECETOC guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default according to ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- All studies listed in REACH Annex VII and REACH Annex VIII have been conducted
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties 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
Please refer to the section Discussion under Workers for information about the applied route-to-route extrapolation and Assessment Factors.
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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