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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.58 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