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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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