Registration Dossier
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EC number: 940-272-6 | CAS number: 2097734-13-7
- 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:
- 15.7 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 175 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 1000 mg/kg bw/day obtained in an oral combined repeated dose (28 days) reproductive toxicity screening study in rats (0, 100, 300 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
For workers:
Corrected inhalatory NOAEC = oralNOAEL x 1/sRVanimal x ABS oral-rat / ABS inh-human x sRVhuman/wRV
The standard respiratory volume (sRV) for the 8 h exposure is 0.38 m³/kg bw for rats and 6.7 m³ (per person) in humans. The default 8-h respiratory volume of a worker (wRV) is 10 m³ taking increased activity into account. The inhalatory absorption in humans is regarded to be slightly higher than the oral absorption in rats. In analogy to the "Evaluation of new scientific evidence concerning DINP and DIDP" by the ECHA (2013), 75% is used for inhalatory absorption in humans, whereas 50% is used for oral absorption in rats.
This results in the following equation:
Corrected inhalatory NOAEC = 1000 mg/kg bw/d x 1/0.38 m³/kg bw x 50 / 75 x 6.7 m³ / 10 m³ = 1175 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- Dose descriptor starting point is the NOAEL of a subacute study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
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:
- 41.7 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 12 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 1000 mg/kg bw/day obtained in an oral combined repeated dose (28 days) reproductive toxicity screening study in rats (0, 100, 300 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
For workers:
Corrected dermal NOAEL = oralNOAEL x ABS oral-rat / ABS dermal-rat x ABS dermal-rat / ABS dermal-human
The dermal absorption in humans is regarded to be very low. In analogy to the "Evaluation of new scientific evidence concerning DINP and DIDP" by the ECHA (2013), 4% is used for dermal absorption in humans, whereas 50% is used for oral absorption in rats.
This results in the following equation:
Corrected dermal NOAEL = 1000 mg/kg x 50 / 4 = 12500 mg/kg
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is derived from a subacute (28 days) repeated dose toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.87 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 580 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 1000 mg/kg bw/day obtained in an oral combined repeated dose (28 days) reproductive toxicity screening study in rats (0, 100, 300 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
General population (in case of 24h exposure/day):
Corrected inhalatory NOAEC = oralNOAEL x 1/sRVanimal x ABS oral-rat / ABS inhalation-human
The standard respiratory volume (sRV) for the 24h exposure is 1.15 m³/kg bw for rats. The inhalatory absorption in humans is regarded to be slightly higher than the oral absorption in rats. In analogy to the "Evaluation of new scientifc evidence concerning DINP and DIDP" by the ECHA (2013), 75% is used for inhalatory absorption in humans, whereas 50% is used for oral absorption in rats.
This results in the following equation:
Corrected inhalatory NOAEC = 1000 mg/kg bw/d x 1/1.15 m³/kg bw x 50 / 75 = 580 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is derived from a subacute (28 days) repeated dose toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
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:
- 20.8 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 12 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 1000 mg/kg bw/day obtained in an oral combined repeated dose (28 days) reproductive toxicity screening study in rats (0, 100, 300 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
For general population:
Corrected dermal NOAEL = oralNOAEL x ABS oral-rat / ABS dermal-rat x ABS dermal-rat / ABS dermal-human
The dermal absorption in humans is regarded to be very low. In analogy to the "Evaluation of new scientific evidence concerning DINP and DIDP" by the ECHA (2013), 4% is used for dermal absorption in humans, whereas 50% is used for oral absorption in rats.
This results in the following equation:
Corrected dermal NOAEL = 1000 mg/kg x 50 / 4 = 12500 mg/kg
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is derived from a subacute (28 days) repeated dose toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
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:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 1000 mg/kg bw/day obtained in an oral combined repeated dose (28 days) reproductive toxicity screening study in rats (0, 100, 300 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
For general population:
Corrected oral NOAEL = oralNOAEL x ABS oral-rat / ABS oral-human
The oral absorption in humans is regarded to be higher than that in the rat. In analogy to the "Evaluation of new scientific evidence concerning DINP and DIDP" by the ECHA (2013), 50% is used for oral absorption in the rat, whereas 100% is used for oral absorption in humans.
This results in the following equation:
Corrected oral NOAEL = 1000 mg/kg x 50 / 100 = 500 mg/kg
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- Dose descriptor starting point is the NOAEL of a subacute study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
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
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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