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EC number: 431-890-2 | CAS number: 166412-78-8
- 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:
- 235 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 3
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 705 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction of starting point from an oral study to the inhalative route according to Guidance on information requirements and chemical safety assessment Chapter R.8.4.2:
40 mg/kg bw/d *1/(0.38 m³/kg bw/d) * (6.7m³/10m³) = 70.5 mg/m3/d
A DINCH concentration in the gas phase higher than 0.5 μg/m3 is not achievable (Schossler et al, 2011; see IUCLID section 7.10.5). Thus, direct respiratory uptake of gaseous DINCH is considered negligible. In addition, in the rare case, DINCH uptake via the respiratory route occured, the vast majority of the uptake is expected to occur indirectly via dust-bound DINCH. According to in vitro data, the respiratory bioaccesibility of DINCH in indoor dust is less than 5% (Kadegoglou, 2018; see IUCLID section 7.1.1). Hence, in a worst case approach, the respiratory absorption of DINCH is considered to be 5% of the total substance-uptake. The oral absorption is considered to be 50% (see IUCLID section 7.1.1).
Taken together, the starting point was corrected as follows:
70.5 mg/m3/d x (50/5) = 705 mg/m3/d
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 42 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 12
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 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:
There is experimental data for the structurally closely related substance DINP (CAS# 68515-48-0), showing that less than 4% of the total applied substance is absorbed by the skin (EU RAR on DINP, 2003). DINCH has an even higher log Kow compared to DINP, making it even less favourable for dermal absorption. Therefore, in a worst case approach, the dermal absorption of DINCH is considered to be 4% of the total applied substance.
The oral absorption is considered to be 50% (see IUCLID section 7.1.1).
Correction of starting point:
NOAEL rat, oral x (Abs rat oral/Abs human dermal)
40 mg/kg bw/d x (50/4) = 500 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 70 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 350 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction of starting point from an oral study to the inhalative route according to Guidance on information requirements and chemical safety assessment Chapter R.8.4.2:
40 mg/kg bw/d *1/(1.15 m³/kg bw/d) = 35 mg/m3/d
A DINCH concentration in the gas phase higher than 0.5 μg/m3 is not achievable (Schossler et al, 2011; see IUCLID section 7.10.5). Thus, direct respiratory uptake of gaseous DINCH is considered negligible. In addition, in the rare case, DINCH uptake via the respiratory route occured, the vast majority of the uptake is expected to occur indirectly via dust-bound DINCH. According to in vitro data, the bioaaccessiblity of DINCH in indoor dust is less than 5% (Kadegoglou, 2018; see IUCLID section 7.1.1). Hence, in a worst case approach, the respiratory absorption of DINCH is considered to be 5% of the total substance-uptake.
The oral absorption is considered to be 50% (see IUCLID section 7.1.1).
Taken together, the starting point was corrected as follows:
35 mg/m3/d x (50/5) = 350 mg/m3/d
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 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:
There is experimental data for the structurally closely related substance DINP (CAS# 68515 -48-0), showing that less than 4% of the total applied substance is absorbed by the skin (EU RAR on DINP, 2003). DINCH has an even higher log Kow compared to DINP, making it even less favourable for dermal absorption. Therefore, in a worst case approach, the dermal absorption of DINCH is considered to be 4% of the total applied substance.
The oral absorption is considered to be 50% (see IUCLID section 7.1.1).
Correction of starting point:
NOAEL rat, oral x (Abs rat oral/Abs human dermal)
40 mg/kg bw/d x (50/4) = 500 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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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