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EC number: 221-201-1 | CAS number: 3030-47-5
- 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:
- 1.058 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.45 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected inhalatory NOAEC = 30 mg/kg bw/day x (1 / 0.38 m3/kg/day) x (50% / 100%) x (6.7 m3 / 10 m3) = 26.45 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues.
- AF for differences in duration of exposure:
- 2
- Justification:
- Based on the fact that NOAEL was derived from the repeated dose 90-day oral toxicity study (OECD 408) the assessment factor of 2 was used (extrapolation from sub-chronic to chronic )
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Additional factor of 2.5 for other interspecies differences was considered for all dose descriptors for PMDETA.
- AF for intraspecies differences:
- 5
- Justification:
- A default assessment factor of 5 was used, based on the fact that workers do not cover the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the quality of data available, AF of 1 was used for PMDETA.
- AF for remaining uncertainties:
- 1
- Justification:
- No further factor used.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral NOAELrat = corrected dermal NOAELhuman = 30 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues.
- AF for differences in duration of exposure:
- 2
- Justification:
- Based on the fact that NOAEL was derived from the repeated dose 90-day oral toxicity study (OECD 408) the assessment factor of 2 was used (extrapolation from sub-chronic to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor of 4 for allometric scalling from rat to human was used for dermal NOAEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Additional factor of 2.5 for other interspecies differences was considered for all dose descriptors for PMDETA.
- AF for intraspecies differences:
- 5
- Justification:
- A default assessment factor of 5 was used, based on the fact that workers do not cover the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the quality of data available, AF of 1 was used for PMDETA.
- AF for remaining uncertainties:
- 1
- Justification:
- No further factor used.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Risk assessment of PMDETA was performed and the NOAEL of 30 mg/kg bw/day, based on the sub-chronic repeated dose 90-day oral toxicity study (OECD 408), was used.
Concerning the reproduction toxicity, the dose descriptors for reproduction and developmental effects, were higher (NOAEL for reproduction toxicity was above 300 mg/kg bw/day (Plodikova P, 2013, and the developmental toxicity NOAEL was above 120 mg/kg bw/day (Hansen B., 2016).
Regarding local effects, based on the results from acute toxicity studies, irritation/corrosion testing and repeated dose toxicity studies, the substance tested is classified as corrosive to skin and eyes.
The available Final Report no. 13-121, on Pentamethyldiethylentriamine: Assessment of Toxicokinetic Behaviour (Koryntova I., Cihak R., 2013) used data from literature, databases and results from the study no. 32/12/19 – Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test, to describe toxicokinetic of the substance tested. Results of the mentioned Final Report are inconclusive, meaning that specific oral, dermal and inhalation absorption rates could not be derived, and, on the other hand, despite the lack of data on systemic effects after dermal and inhalation exposure to the PMDETA, the possibility of dermal and inhalation absorption could not be excluded.
Based on the fact that there are no available toxicokinetic studies and hence no specific data on the oral, dermal and inhalation absorption rates for the substance tested, the absorption rates used in the DNEL derivations were the default values based on ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterization of dose [concentration]-response for human health.
The default values were used as follows:
Oral absorption in rat = oral absorption in human
Oral absorption in rat = dermal absorption in human
50% absorption by oral route in rat = 100% absorption for inhalation in human
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.261 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.04 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected inhalatory NOAEC = 30 mg/kg bw/day x (1 / 1.15 m3/kg/day) x (50% / 100%) = 13.04 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues.
- AF for differences in duration of exposure:
- 2
- Justification:
- Based on the fact that NOAEL was derived from the repeated dose 90-day oral toxicity study (OECD 408) the assessment factor of 2 was used (extrapolation from sub-chronic to chronic).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Additional factor of 2.5 for other interspecies differences was considered for all dose descriptors for PMDETA.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the quality of data available, AF of 1 was used for PMDETA.
- AF for remaining uncertainties:
- 1
- Justification:
- No further factor used.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral NOAELrat = corrected dermal NOAELhuman = 30 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues.
- AF for differences in duration of exposure:
- 2
- Justification:
- Based on the fact that NOAEL was derived from the repeated dose 90-day oral toxicity study (OECD 408) the assessment factor of 2 was used (extrapolation from sub-chronic to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor of 4 for allometric scalling from rat to human was used for dermal NOAEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Additional factor of 2.5 for other interspecies differences was considered for all dose descriptors for PMDETA.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the quality of data available, AF of 1 was used for PMDETA.
- AF for remaining uncertainties:
- 1
- Justification:
- No further factor used.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues.
- AF for differences in duration of exposure:
- 2
- Justification:
- Based on the fact that NOAEL was derived from the repeated dose 90-day oral toxicity study (OECD 408) the assessment factor of 2 was used (extrapolation from sub-chronic to chronic).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor of 4 for allometric scalling from rat to human was used for dermal NOAEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Additional factor of 2.5 for other interspecies differences was considered for all dose descriptors for PMDETA.
- AF for intraspecies differences:
- 10
- Justification:
- A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the quality of data available, AF of 1 was used for PMDETA.
- AF for remaining uncertainties:
- 1
- Justification:
- No further factor used.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Risk assessment of PMDETA was performed and the NOAEL of 30 mg/kg bw/day, based on the sub-chronic repeated dose 90-day oral toxicity study (OECD 408), was used.
Concerning the reproduction toxicity, the dose descriptors for reproduction and developmental effects, were higher (NOAEL for reproduction toxicity was above 300 mg/kg bw/day (Plodikova P, 2013, and the developmental toxicity NOAEL was above 120 mg/kg bw/day (Hansen B., 2016).
Regarding local effects, based on the results from acute toxicity studies, irritation/corrosion testing and repeated dose toxicity studies, the substance tested is classified as corrosive to skin and eyes.
The available Final Report no. 13-121, on Pentamethyldiethylentriamine: Assessment of Toxicokinetic Behaviour (Koryntova I., Cihak R., 2013) used data from literature, databases and results from the study no. 32/12/19 – Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test, to describe toxicokinetic of the substance tested. Results of the mentioned Final Report are inconclusive, meaning that specific oral, dermal and inhalation absorption rates could not be derived, and, on the other hand, despite the lack of data on systemic effects after dermal and inhalation exposure to the PMDETA, the possibility of dermal and inhalation absorption could not be excluded.
Based on the fact that there are no available toxicokinetic studies and hence no specific data on the oral, dermal and inhalation absorption rates for the substance tested, the absorption rates used in the DNEL derivations were the default values based on ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterization of dose [concentration]-response for human health.
The default values were used as follows:
Oral absorption in rat = oral absorption in human
Oral absorption in rat = dermal absorption in human
50% absorption by oral route in rat = 100% absorption for inhalation in human
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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