Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.7 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
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
617.1 mg/m³
Explanation for the modification of the dose descriptor starting point:

The lowest NOAEL for (maternal) systemic toxicity, 50 mg/kg bw/d, was established in the developmental toxicity study (OECD 414) in rats. However, under good industrial hygiene practices, pregnant women should not be exposed to chemicals. Therefore, the DNEL for long-term exposure is derived from the no observed effect level of 250 mg/kg bw/d obtained in an oral repeated dose toxicity study (OECD 408). The calculation of DNEL is based on the no observed adverse effect level which has to be modified as described in R8 (ECHA, May 2008).  For derivation of the inhalative long-term DNEL, the oral NOAEL had to be extrapolated (oral to inhalative) and corrected for interspecies difference between rat and human by the risk assessors: 0.38 mg/m3 (standard respiration volume rat, 8 hours), 6.7 m3 (standard respiration volume human, 8 hours) and 10 m3 (standard respiration volume worker, 8 hours) and 7d/5d (7 days/week of oral exposure during the study, 5 days/week exposure of the workers). An inhalative NOAEC of 250/0.38*6.7/10*7/5 = 617.1 mg/m3 was obtained.
Based on the low molecular weight (130.3 g/mol), the high water solubility), and the low log Pow (0.36 at 25°C) it is assumed that oral absorption of the test substance is very high (R7c, ECHA, May 2008). Consequently, a default factor of 1 is included for route-to-route extrapolation, which means that 100% absorption is assumed for oral absorption, and 100% for inhalation.

AF for dose response relationship:
1
Justification:
Not needed
AF for differences in duration of exposure:
2
Justification:
Default value
AF for interspecies differences (allometric scaling):
1
Justification:
Not needed
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Not needed
AF for remaining uncertainties:
1
Justification:
Not needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
DNEL extrapolated from long term DNEL

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 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
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
350 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The DNEL for long-term dermal exposure is derived from the no observed effect level of 250 mg/kg bw/d obtained in an oral repeated dose toxicity study (OECD 408). The calculation of DNEL is based on the no observed adverse effect level which has to be modified as described in R8 (ECHA, May 2008). For derivation of the dermal long-term DNEL, the oral NOAEL had to be extrapolated (oral to dermal) and corrected for weekly duration of exposure (7 days/week of oral exposure during the study, 5 days/week exposure of the workers). A dermal NOAEL of 250*7/5 = 350 mg/kg bw/d was obtained.
Acute LD50 values are similar either by the oral or dermal routes indicating a similar absorption by both routes of administration.
AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
2
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The Acute dermal toxicity of 3-aminopropyldiethylamine was evaluated male New Zealand white rabbits, the LD50 was 0.64 ml/kg 524 mg/kg). However, the study is insufficiently detailled to derive a DNEL.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 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
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
43.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL for long-term exposure is derived from the no observed effect level of 50 mg/kg bw/d obtained in a developmental toxicity study (OECD 414). The calculation of DNEL is based on the no observed adverse effect level which has to be modified as described in R8 (ECHA, May 2008).  For derivation of the inhalative long-term DNEL, the oral NOAEL had to be extrapolated (oral to inhalative) and corrected for interspecies difference between rat and human by the risk assessors: 1.15 mg/m3 (standard respiration volume rat, 24 hours). An inhalative NOAEC of 50/1.15 = 43.5 mg/m3 was obtained.

AF for dose response relationship:
1
Justification:
Not needed
AF for differences in duration of exposure:
1
Justification:
Default value
AF for interspecies differences (allometric scaling):
1
Justification:
Not needed
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Not needed
AF for remaining uncertainties:
1
Justification:
Not needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for long-term exposure is derived from the no observed effect level of 50 mg/kg bw/d obtained in a developmental toxicity study (OECD 414).

AF for dose response relationship:
1
Justification:
Not needed
AF for differences in duration of exposure:
1
Justification:
Default value
AF for interspecies differences (allometric scaling):
2.5
Justification:
Default value
AF for other interspecies differences:
4
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Not needed
AF for remaining uncertainties:
1
Justification:
Not needed
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population