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EC number: 939-783-7 | CAS number: -
- 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:
- no hazard identified
- Value:
- 24 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 3.4 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the component diisotridecyl adipate and the read-across substance bis (2 -ethylhexyl) adipate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across).
Acute / short-term exposure - systemic effects
In acute toxicity studies, the comonent diisotridecyl adipate has been shown to be of low systemic toxicity.
LD50 oral: > 15000 mg/kg bw in rats (Moreno/Mobil, 1978a)
LD50 dermal: > 5000 mg/kg bw in rabbits (Moreno/Mobil, 1978b).
From present studies, reliable short-term dose response relations cannot be deduced. Available data do not provide sufficient information on sublethal toxic effects to gather NOAELs as starting points. DNELs cannot be derived.
In accordance with ECHA Guidance on information requirements and chemical safety assessment - Chapter R.8, DN(M)EL need not be derived in case of low acute toxicity.
Acute /short-term exposure - local effects
The component Diisotridecyl adipate is not irritating to skin or to eyes. Data on inhalation exposure could not be located.
From the data available, reliable dose descriptors cannot be obtained. DNELs cannot be derived as there are no suitable starting points.
Long term exposure systemic effects
To assess the risk of long-term exposure - systemic effects for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol, data for di-2-ethylhexyl adipate as supporting substance will be used based on the close structural relationship of both substances (Justification in more detail is presented in endpoint summary to section 7.1.1 - basic toxicokinetics).
For di-2-ethylhexyl adipate, several valid studies concerning repeated dose toxicity are available. Besides a 28 day oral study (Miyata, 2006), the substance was investigated by NTP in subchronic and chronic studies in two species (rat and mouse) (NTP, 1982). In addition, there is an oral one-generation reproduction toxicity study with an exposure period of 10 weeks for parental animals (Cefic, 1989).
Other administration routes have been examined for diisotridecyl adipate itself (Mobil, 1989, aerosol inhalation for 14 days) and for ditridecyl adipate (HPV TP, 2003, dermal,13 weeks). This data are of low reliability and are not used for the derivation of DNELs.
The most critical NOAEL was observed in the one-generation study (170 mg/kg bw/day - effects on the offspring: reduced total litter weight and reduced mean litter size). At the same time, this is the lowest NOAEL determined in repeated dose toxicity studies. This value will be taken for derivation of a DNEL for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol.
DNELs for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol
The NOAEL of 170 mg/kg bw/day determined for di-2-ethylhexyl adipate is used for the DNEL-derivation.
Worker long term exposure - systemic effects (oral, dermal and inhalation) DNELs were calculated form the NOAEL, assuming a 100 % dermal
(worst case) and inhalation rate.
DNEL dermal - systemic effects
According to ECHA TGD Guidance on information requirements and chemical safety assessment -Chapter R.8: Characterisation of dose[concentration]-response for human health, the NOAEL oral can be used for the deduction of a DNEL dermal without further adjustment. As default, absorption for oral and dermal route is considered equal as long as more definite experimental information is not available.
Assessment factors used are a) allometric scaling factor of 4, b) factor for remaining interspecies differences of 2.5, c) intraspecies factor (worker) of 5. The factor for sub-chronic to chronic exposure extrapolation is set to 1 as for developmental effects chronic exposure is not relevant. With a starting point NOAEL dermal of 170 mg/kg bw/day and an overall assessment factor of 50, a DNEL of 3.4 mg/kg bw/day for
Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is calculated.
DNEL inhalation -systemic effects
The corrected worker inhalation starting point was the corrected NOAEC of 300 mg/m3 and was derived form the oral NOAEL of 170 mg/kg bw/day multiplying by the inverse of the standard respiratory volume of the rat during an 8 hour period (2.63) and multiplied by the ratio of standard respiratory volume for humans to the 8 hour worker standard respiratory volume (0.67). The corrected starting point was adjusted by a factor of 12.5
(factor for remaining interspecies differences 2.5, intraspecies factor (worker) 5, factor for sub-chronic to chronic exposure extrapolation 1, see above)resulting in an calculated DNEL of 24 mg/m3.
Long-term exposure - local effects
The irritation potential of Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol
is low as demonstrated in acute skin and eye irritation tests. Dose descriptors for long term exposure local effects are not available. DNELs for long-term-exposure local effects are not derived.General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 10.44 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 1.7 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 1.77 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the component diisotridecyl adipate and the read-across substance bis(2 -ethylhexyl) adipate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification for read-across).
Acute / short-term exposure - systemic effects
In acute toxicity studies, the component diisotridecyl adipate has been shown to be of low systemic toxicity.
LD50 oral: > 15000 mg/kg bw in rats (Moreno/Mobil, 1978a)
LD50 dermal: > 5000 mg/kg bw in rabbits (Moreno/Mobil, 1978b).
From present studies, reliable short-term dose response relations cannot be deduced. Available data do not provide sufficient information on sublethal toxic effects to gather NOAELs as starting points. DNELs cannot be derived.
In accordance with ECHA Guidance on information requirements and chemical safety assessment - Chapter R.8, DN(M)EL need not be derived in case of low acute toxicity.
Acute /short-term exposure - local effects
The component Diisotridecyl adipate is not irritating to skin or to eyes. Data on inhalation exposure could not be located.
From the data available, reliable dose descriptors cannot be obtained. DNELs cannot be derived as there are no suitable starting points.
Long term exposure systemic effects
To assess the risk of long-term exposure - systemic effects for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol, data for di-2-ethylhexyl adipate as supporting substance will be used based on the close structural relationship of both substances (Justification in more detail is presented in endpoint summary to section 7.1.1 - basic toxicokinetics).
For di-2-ethylhexyl adipate, several valid studies concerning repeated dose toxicity are available. Besides a 28 day oral study (Miyata, 2006), the substance was investigated by NTP in subchronic and chronic studies in two species (rat and mouse) (NTP, 1982). In addition, there is an oral one-generation reproduction toxicity study with an exposure period of 10 weeks for parental animals (Cefic, 1989).
Other administration routes have been examined for diisotridecyl adipate itself (Mobil, 1989, aerosol inhalation for 14 days) and for ditridecyl adipate (HPV TP, 2003, dermal,13 weeks). This data are of low reliability and are not used for the derivation of DNELs.
The most critical NOAEL was observed in the one-generation study (170 mg/kg bw/day - effects on the offspring: reduced total litter weight and reduced mean litter size). At the same time, this is the lowest NOAEL determined in repeated dose toxicity studies. This value will be taken for derivation of a DNEL for Reaction product of adipic acid and sebacic acid and isotredecan-1 -ol.
DNELs for Reaction product of adipic acid and sebacic acid and isotredecan-1 -ol
The NOAEL of 170 mg/kg bw/day determined for di-2-ethylhexyl adipate is used for the DNEL-derivation.
General population long-term exposure - systemic effects (oral, dermal and inhalation) DNELs were calculated form the NOAEL, assuming a 100 % dermal (worst case) and inhalation absorption rate.
DNEL dermal and oral- systemic effects
According to ECHA TGD Guidance on information requirements and chemical safety assessment -Chapter R.8: Characterisation of dose[concentration]-response for human health, the NOAEL oral can be used for the deduction of a DNEL dermal without further adjustment. As default, absorption for oral and dermal route is considered equal as long as more definite experimental information is not available.
Assessment factors used are a) allometric scaling factor of 4, b) factor for remaining interspecies differences of 2.5, c) intraspecies factor (general population) of 10. The factor for sub-chronic to chronic exposure extrapolation is set to 1 as for developmental effects chronic exposure is not relevant. With a starting point NOAEL dermal of 170 mg/kg bw/day and an overall assessment factor of 100, a DNEL of 1.7 mg/kg bw/day for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is calculated.
DNEL inhalation -systemic effects
The corrected worker inhalation starting point was the corrected NOAEC of 300 mg/m3 and was derived form the oral NOAEL of 170 mg/kg bw/day multiplying by the inverse of the standard respiratory volume of the rat during an 24 hour period (0.87). The corrected starting point was adjusted by a factor of 25 (factor for remaining interspecies differences 2.5, intraspecies factor (general population) 10, factor for sub-chronic to chronic exposure extrapolation 1, see above) resulting in an calculated DNEL of 10.44 mg/m3.
Long-term exposure - local effects
The irritation potential of Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is low as demonstrated
in acute skin and eye irritation tests. Dose descriptors for long term exposure local effects are not available. DNELs for long-term-exposure local effects are not derived.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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