Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.98 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
17.7 mg/m³
Explanation for the modification of the dose descriptor starting point:
(20 × 1/0.38 × 6.7/10 × 0.5 [50% oral abs rat / 100% inhalation abs hum]
AF for dose response relationship:
1
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and ECETOC Technical Report No. 110.
AF for interspecies differences (allometric scaling):
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point
AF for other interspecies differences:
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point
AF for intraspecies differences:
3
Justification:
Default value in ECETOC Technical Report No. 110.
AF for the quality of the whole database:
3
Justification:
Very recent OECD 408 study on highly similar read across substance.
AF for remaining uncertainties:
1
Justification:
Default value in ECETOC Technical Report No. 110.
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.55 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):
72
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
(20 × 2 [oral absorption rat 50%/dermal absorption human 25%]
AF for dose response relationship:
3
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and ECETOC Technical Report No. 110.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for other interspecies differences:
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point
AF for intraspecies differences:
3
Justification:
Default value in ECETOC Technical Report No. 110.
AF for the quality of the whole database:
1
Justification:
Very recent OECD 408 study on highly similar read across substance
AF for remaining uncertainties:
1
Justification:
Default value in ECETOC Technical Report No. 110.
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Tall oil, compound with diethanolamine is not acutely toxic after oral administration, as the LD50 values are higher than 2000 mg/kg bw. The substance did show irritating properties to both skin and eye when tested in vivo, but there is no dose response data.Based on results of GPMTs with component substances (diethanolamine and distilled tall oil) the compound is not considered to be a sensitiser. Therefore acute DNELs for systemic effects or acute and long-term DNELs for local effects are not possible to define.

Results of in vitro studieswith the component substances showed tall oil, compound with diethanolamineis considered not to possess any genotoxic potential.

 

A oral repeat-dose 90 day toxicity study in rats on the read across substance Diethanolamine was available. As this was the most recent study and was conducted on the closest structural analogue it was used as the starting point for DNELs setting. An additional oral repeat-dose combined reproductive/developmental toxicity study on the read across substance tall oil and further repeat dose studies both oral and dermal on the component substances are also available to help support the read across and address this end point.

All assessment factors were the default values taken from ECETOC Technical Report No. 110, Guidance on Assessment Factors to Derive a DNEL. To prepare this publication, ECETOC conducted an extensive and documented review of the scientific literature. Therefore, the AF supplied in the ECETOC document are considered valid and scientifically justifiable.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.29 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
8.7 mg/m³
Explanation for the modification of the dose descriptor starting point:
(20 × 1/1.15 × × 0.5 [50% oral abs rat / 100% inhalation abs hum]
AF for dose response relationship:
3
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for interspecies differences (allometric scaling):
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point
AF for other interspecies differences:
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110.
AF for the quality of the whole database:
1
Justification:
Very recent OECD 408 study on highly similar read across substance.
AF for remaining uncertainties:
1
Justification:
Default value in ECETOC Technical Report No. 110.
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:
DNEL (Derived No Effect Level)
Value:
0.33 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL = 20 mg/kg/day (20 × 2 [oral absorption rat 50%/dermal absorption human 25%]
AF for dose response relationship:
3
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for other interspecies differences:
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point
AF for intraspecies differences:
5
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
AF for the quality of the whole database:
1
Justification:
Very recent OECD 408 study on highly similar read across substance
AF for remaining uncertainties:
1
Justification:
default value in ECETOC Technical Report No. 110.
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
AF for dose response relationship:
3
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements anddefault value in ECETOC Technical Report No. 110.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Technical Report No. 110.
AF for intraspecies differences:
5
Justification:
default value in ECETOC Technical Report No. 110.
AF for the quality of the whole database:
1
Justification:
Very recent OECD 408 study on highly similar read across substance
AF for remaining uncertainties:
1
Justification:
default value in ECETOC Technical Report No. 110.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Tall oil, compound with diethanolamine is not acutely toxic after oral administration, as the LD50 values are higher than 2000 mg/kg bw. The substance did show irritating properties to both skin and eye when tested in vivo, but there is no dose response data. Based on results of GPMTs with component substances (diethanolamine and distilled tall oil) the compound is not considered to be a sensitiser. Therefore acute DNELs for systemic effects or acute and long-term DNELs for local effects are not possible to define.

Results of in vitro studies with the component substances showed tall oil, compound with diethanolamine is considered not to possess any genotoxic potential.

 

A oral repeat-dose 90 day study in rats on the read across diethanolamine was available, performed in rats. As this was the most recent study and was conducted on the closest structural analogue it was used as the starting point for DNELs setting. An additional oral repeat-dose combined reproductive/developmental toxicity study on the read across substance tall oil and further repeat dose studies both oral and dermal on the component substances are also available to help support the read across and address this end point.

All assessment factors were the default values taken from ECETOC Technical Report No. 110, Guidance on Assessment Factors to Derive a DNEL. To prepare this publication, ECETOC conducted an extensive and documented review of the scientific literature. Therefore, the AF supplied in the ECETOC document are considered valid and scientifically justifiable.