Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.033 mg/m³
Most sensitive endpoint:
effect on fertility
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:
1.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2.64 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of dodecylphenolate (phenol, dodecyl-,branched, TPP), i.e. expressed as mg TPP/kg bw/day and mg TPP/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium 4 -dodecylphenolate/m³ recalculated for barium 4 -dodecylphenolate based on a maximum dodecylphenolate content of 81 %.

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
high quality assessment from OECD available
AF for remaining uncertainties:
1
Justification:
ECHA default
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.019 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
1.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of dodecylphenolate (phenol, dodecyl-,branched, TPP), i.e. expressed as mg TPP/kg bw/day and mg TPP/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium 4 -dodecylphenolate/m³ recalculated for barium 4 -dodecylphenolate based on a maximum dodecylphenolate content of 81 %.

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
high quality assessment from OECD available
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.008 mg/m³
Most sensitive endpoint:
effect on fertility
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:
1.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of dodecylphenolate (phenol, dodecyl-,branched, TPP), i.e. expressed as mg TPP/kg bw/day and mg TPP/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium 4 -dodecylphenolate/m³ recalculated for barium 4 -dodecylphenolate based on a maximum dodecylphenolate content of 81 %.

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
high quality assessment from OECD available
AF for remaining uncertainties:
1
Justification:
ECHA default
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.009 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
1.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of dodecylphenolate (phenol, dodecyl-,branched, TPP), i.e. expressed as mg TPP/kg bw/day and mg TPP/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium 4 -dodecylphenolate/m³ recalculated for barium 4 -dodecylphenolate based on a maximum dodecylphenolate content of 81 %.

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
high quality assessment from OECD available
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
0.009 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
1.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of dodecylphenolate (phenol, dodecyl-,branched, TPP), i.e. expressed as mg TPP/kg bw/day and mg TPP/m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg barium 4 -dodecylphenolate/m³ recalculated for barium 4 -dodecylphenolate based on a maximum dodecylphenolate content of 81 %.

Route to route extrapolation performed in accordance with ECHA Guidance R.8, Appendix R.8 -2 (page 57ff.).

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
high quality assessment from OECD available
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
no hazard identified

Additional information - General Population