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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.58 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEC
Value:
236.3 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
118.74 mg/m³
Explanation for the modification of the dose descriptor starting point:

The inhalation rat systemic NOAEC of 236.3 mg/m³ (BASF, 2013) for the nearest analogue Dibutylethanolamine (CAS 102-81-1) served as the starting point for the DNEL derivation. It originated from an inhalative combined Repeated Dose and Reproduction/Developmental Toxicity Screening Test (OECD 422, 413). This is the study with the longest test duration. The NOAEC was converted by considering the exposure duration (6 h/day for rats in the performed study and 8 h for human during one working shift) and the standard respiratory volumes (6.7 m³ for workers under normal condition and 10 m³ under light activity).


 


236.3 mg/m³ * (6.7 m³/10 m³) * (6h/d / 8h/d) = 118.74 mg/m³

AF for dose response relationship:
1
Justification:
clear dose response
AF for differences in duration of exposure:
6
Justification:
Default value for time extrapolation from subacute to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not necessary, as no route-to-route extrapolation is applied and doses expressed as concentrations are assumed to be already scaled.
AF for other interspecies differences:
2.5
Justification:
default for differences in toxicodynamics
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties have been identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.14 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC, Technical Report No. 110
Overall assessment factor (AF):
18
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
clear dose response
AF for differences in duration of exposure:
6
Justification:
Default value for time extrapolation from subacute to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling in case of local effects
AF for other interspecies differences:
1
Justification:
No other differences are identified
AF for intraspecies differences:
3
Justification:
As respiratory irritation due to the caustic property of the read-across substance Dibutylaminothanol is the leading effect, no huge differences within humans are expected. Therefore, the AF for worker intraspecies differences was set to 3 as recommended in "Guidance on assessment factors to derive a DNEL", Technical Report No. 110, ECETOC, 2010.
AF for the quality of the whole database:
1
Justification:
read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties are identified in case of respiratory irritation
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:
7 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:
700 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL of 50 mg/kg bw/day for DBEA (OECD 408; BASF 2020) corrected for differences in experimental exposure conditions: workers (5 working days) vs. rats (7 days continuous exposure) and differences in absorption rates for oral (100 %) and dermal route (10 %)


50 mg/kg bw/d * 7/5 * 100/10 = 700 mg/kg bw/d

AF for dose response relationship:
1
Justification:
Clear dose response
AF for differences in duration of exposure:
2
Justification:
Default value for time extrapolation from sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default for toxicodynamics differences
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties have been identified.
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:
medium 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:
0.281 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEC
Value:
236.3 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
42.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

The inhalation rat systemic NOAEC of 236.3 mg/m³ (BASF, 2013) for the nearest analogue Dibutylethanolamine (CAS 102-81-1) served as the starting point for the DNEL derivation. It originated from an inhalative combined Repeated Dose and Reproduction/Developmental Toxicity Screening Test (OECD 422, 413). The NOAEC was converted by considering the exposure duration (6 h/day and 5 d/week for rats in the performed study and 24 h/day and 7d/week for human).


 


236.3 mg/m³ * 5/7 * 6/24 = 42.2 mg/m³

AF for dose response relationship:
1
Justification:
clear dose response
AF for differences in duration of exposure:
6
Justification:
Default value for time extrapolation from subacute to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not necessary, as no route-to-route extrapolation is applied and doses expressed as concentrations are assumed to be already scaled.
AF for other interspecies differences:
2.5
Justification:
default for differences in toxicodynamics
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties have been identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.34 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Clear dose response
AF for differences in duration of exposure:
6
Justification:
Default value for time extrapolation from subacute to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Default in case of local effects
AF for other interspecies differences:
1
Justification:
Local effects in respiratory tract of animals and humans have been considered not to depend on toxycodinamics
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties have been 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:
2.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL of 50 mg/kg bw/day for DBEA (OECD 408; BASF 2020) is corrected for differences in absorption rats for oral (100 %) and dermal route (10 %)


50 mg/kg bw/d * 100/10 = 500 mg/kg bw/d

AF for dose response relationship:
1
Justification:
Clear dose response
AF for differences in duration of exposure:
2
Justification:
Default value for time extrapolation from sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default for toxicodynamics differences
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties have been identified
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:
0.25 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
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 oral NOAEL of 50 mg/kg bw/day for DBEA (OECD 408; BASF 2020) is used as starting point. It does not need to be corrected.

AF for dose response relationship:
1
Justification:
Clear dose response
AF for differences in duration of exposure:
2
Justification:
Default value for time extrapolation from sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default for toxicodynamics differences
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Read-across data (substance acts in a similar toxicological pattern)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties have been identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population