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Diss Factsheets
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EC number: 249-079-5 | CAS number: 28553-12-0
- 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:
- 51.72 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 23
- Modified dose descriptor starting point:
- NOAEC
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:
- 366 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- Modified dose descriptor starting point:
- NOAEL
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 remarks
The most appropriate endpoint for derivation of DNELs is the rat oral NOAEL of 88 mg/kg-bw/day assumed from a well-conducted chronic / carcinogenicity rat study according to GLP (Moore, 1998), based on liver toxicity at higher doses consisting of hepatic biochemical changes (increased ALT, AST), of liver weight increase in both sexes concurrently with histopathological findings, and increased kidney weight in both sexes. This NOAEL is conservative by nature since the mechanism of toxicity, peroxisome proliferation via PPARα, is not relevant to humans. In all cases, calculations were based on default assumptions as defined in the REACH guidance document.
WORKERS
Inhalation
Due to its extremely low vapour pressure, DINP vapour phase concentrations are unlikely to attain high levels, even at high temperatures used in some industrial conditions. At 20ºC, DINP has a vapour pressure of 6E10-5 Pa and a calculated saturated vapour concentration of 10 µg/m3.
At high temperatures and mechanical pressures, aerosol formation is observed with DINP like with other phthalates. Exposure to aerosol is therefore possible in any situation where pure DINP is heated or materials containing DINP are heated under influence of mechanical pressure. Exposure to DINP aerosol is likely to result in limited absorption through the lungs and is more likely to result in oral absorption due to mucocilliary clearance. The protective value used to calculate and inhalation DNEL is derived from the oral NOAEL 88 mg/kg/day as opposed to the data presented in the 2-week repeated dose study with aerosolized DIDP in which the limit dose was tested and no systemic effects were reported.
Dose descriptor
rat oral NOAEL = 88 mg/kg/day
Assumptions
100% oral absorption regardless of species
100% inhalation absorption regardless of species
Modification of dose descriptorcalculation B.3 in ECHA Guidance R.8
inhalatory NOAEC = oral NOAEL * (1/ sRV rat 8h) * (ABS oral / ABS inh) * (sRV human / wRV)
inhalatory NOAEC= 88 * (1/0.38) * (100/100) * (6.7 / 10)
inhalatory NOAEC = 155.16 mg/m3
Assessment factors – Based on ECETOC guidance document #86
Uncertainty |
AF |
Justification |
workers |
3 |
default workers |
Overall AF |
3 |
|
DNELworker inhalation= 155.16 mg/m3/ 3
= 51.72 mg/m3
Dermal
DINP, like other high molecular weight phthalates, has a very low dermal penetration rate (2-4%). While a repeated dose dermal study is available for DINP, it is not suitable for DNEL calculation due to several study limitations;it is an old study (1969) performed prior to GLP, a small number of animals were used (n=4 per group where 2 were abraded and 2 were not), there was an in-house infection in which animals in the control and treated groups died and the others required pharmacological intervention, an incomplete histopathological analysis was performed (only liver, kidney, and skin were examined).
A dermal DNEL will be calculated from route to route extrapolation from the rat oral NOAEL of 88 mg/kg/day. This value is expected to be protective since there are clear dose responses via the oral route of exposure and it is highly unlikely that enough material could be applied to animals, since the dermal penetration rate is so low (2%), to observe similar effects.
Dose descriptor
rat oral NOAEL = 88 mg/kg/day.
Assumptions
100% oral absorption regardless of species
2% dermal absorption regardless of species
Modification of dose descriptor
Route-to-route extrapolation (calculation B.5 in ECHA Guidance R.8):
dermal NOAEL = oral NOAEL * (ABS oral / ABS dermal)
dermal NOAEL = 88 mg/kg/day * (100/2)
dermal NOAEL = 4400 mg/kg/day
Assessment factors – Based on ECETOC guidance document #86
Uncertainty |
AF |
Justification |
Allometric scaling |
4 |
default for the rat |
Intraspecies differences |
3 |
default AF for workers |
Overall AF |
12 |
|
DNELworker
dermal = 4400
mg/kg bwt/d / 12
= 366 mg/kg bwt/d
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
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:
- 220 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
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:
- 4.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
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
General remarks
The most appropriate endpoint for derivation of DNELs is the rat oral NOAEL of 88 mg/kg-bw/day assumed from a well-conducted chronic / carcinogenicity rat study according to GLP (Moore, 1998), based on liver toxicity at higher doses consisting of hepatic biochemical changes (increased ALT, AST), of liver weight increase in both sexes concurrently with histopathological findings, and increased kidney weight in both sexes. This NOAEL is conservative by nature since the mechanism of toxicity, peroxisome proliferation via PPARα, is not relevant to humans. In all cases, calculations were based on default assumptions as defined in the REACH guidance document.
GENERAL POPULATION
Inhalation
Due to its extremely low vapour pressure, DINP vapour phase concentrations are unlikely to attain high levels, even at high temperatures used in some industrial conditions. At 20ºC, DINP has a vapour pressure of 6E10-5 Pa and a calculated saturated vapour concentration of 10 µg/m3.
At high temperatures and mechanical pressures, aerosol formation is observed with DINP like with other phthalates. Exposure to aerosol is therefore possible in any situation where pure DINP is heated or materials containing DINP are heated under influence of mechanical pressure. Exposure to DINP aerosol is likely to result in limited absorption through the lungs and is more likely to result in oral absorption due to mucocilliary clearance. The protective value used to calculate and inhalation DNEL is derived from the oral NOAEL 88 mg/kg/day as opposed to the data presented in the 2-week repeated dose study with aerosolized DIDP in which the limit dose was tested and no systemic effects were reported.
Dose descriptor
rat oral NOAEL = 88 mg/kg/day
Assumptions
100% oral absorption regardless of species
100% inhalation absorption regardless of species
Modification of dose descriptorcalculation B.3 in ECHA Guidance R.8
inhalatory NOAEC = oral NOAEL * (1/ sRV rat 24h) * (ABS oral / ABS inh)
inhalatory NOAEC= 88 * (1/1.15) * (100/100) * (6.7 / 10)
inhalatory NOAEC = 76.52 mg/m3
Assessment factors – based on ECETOC Guidance document #86
Uncertainty |
AF |
Justification |
workers |
5 |
default population |
Overall AF |
5 |
|
DNELpopulation inhalation = 76.52 mg/m3/ 5
= 15.30 mg/m3
Dermal
DINP, like other high molecular weight phthalates, has a very low dermal penetration rate (2-4%). While a repeated dose dermal study is available for DINP, it is not suitable for DNEL calculation due to several study limitations;it is an old study (1969) performed prior to GLP, a small number of animals were used (n=4 per group where 2 were abraded and 2 were not), there was an in-house infection in which animals in the control and treated groups died and the others required pharmacological intervention, an incomplete histopathological analysis was performed (only liver, kidney, and skin were examined).
A dermal DNEL will be calculated from route to route extrapolation from the rat oral NOAEL of 88 mg/kg/day. This value is expected to be protective since there are clear dose responses via the oral route of exposure and it is highly unlikely that enough material could be applied to animals, since the dermal penetration rate is so low (2%), to observe similar effects.
Dose descriptor
rat oral NOAEL = 88 mg/kg/day.
Assumptions
100% oral absorption regardless of species
2% dermal absorption regardless of species
Modification of dose descriptor
Route-to-route extrapolation (calculation B.5 in ECHA Guidance R.8):
dermal NOAEL = oral NOAEL * (ABS oral / ABS dermal)
dermal NOAEL = 88 mg/kg/day * (100/2)
dermal NOAEL = 4400 mg/kg/day
Assessment factors
Uncertainty |
AF |
Justification |
Allometric scaling |
4 |
default for the rat |
Intraspecies differences |
5 |
default AF for population |
Overall AF |
20 |
|
DNELpopulation
dermal= 4400
mg/kg bwt/d / 20
= 220 mg/kg bwt/d
Oral
Dose descriptor
rat oral NOAEL = 88 mg/kg/day
Modification of dose descriptor
No modification is required (daily dosing)
Assessment factors – Based on ECETOC guidance document #86
Uncertainty |
AF |
Justification |
Interspecies differences |
4 |
default for rat |
Intraspecies differences |
5 |
default AF for general population |
Overall AF |
20 |
|
DNELl-t oral = 88 mg/kg bwt/d / 20
= 4.4 mg/kg bwt/d
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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