Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.63 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
176.32 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 2-ethylhexanoic acid (2Et), i.e. expressed as mg 2Et/kg bw/day and mg 2Et /m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg magnesium 2-ethylhexanoate/m³". 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:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default: rat
AF for other interspecies differences:
2.5
Justification:
ECHA default: remaining differences
AF for intraspecies differences:
5
Justification:
ECHA default: worker
AF for the quality of the whole database:
1
Justification:
high quality
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:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The same bioavailability is assumed for humans and animals, thus no modification required (in accordance with ECHA Guidance R.8, Chapter R.8.4, page 17ff.).

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 2-ethylhexanoic acid (2Et), i.e. expressed as mg 2Et/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg magnesium 2-ethylhexanoate/kg bw/day".

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:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default: rat
AF for other interspecies differences:
2.5
Justification:
ECHA default: remaining differences
AF for intraspecies differences:
5
Justification:
ECHA default: worker
AF for the quality of the whole database:
1
Justification:
high qualitiy
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:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

In order to evaluate toxicological properties of the substance magnesium 2‑ethylhexanoate, information on the assessment entities magnesium cation and 2‑ethylhexanoate anion were considered. For a documentation and justification of that approach, please refer to the separate document attached to section 13, namely Read Across Assessment Report for magnesium 2‑ethylhexanoate.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.16 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
86.96 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 2-ethylhexanoic acid (2Et), i.e. expressed as mg 2Et/kg bw/day and mg 2Et /m³ respectively. The DNEL is given on a substance specific basis, i.e. expressed as "mg magnesium 2-ethylhexanoate/m³". 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:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default: rat
AF for other interspecies differences:
2.5
Justification:
ECHA default: remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default: general population
AF for the quality of the whole database:
1
Justification:
high quality
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:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The same bioavailability is assumed for humans and animals, thus no modification required (in accordance with ECHA Guidance R.8, Chapter R.8.4, page 17ff.).

Dose descriptor starting point and modified dose descriptor starting point derived on the basis of 2-ethylhexanoic acid (2Et), i.e. expressed as mg 2Et/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg magnesium 2-ethylhexanoate/kg bw/day".

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:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default: rat
AF for other interspecies differences:
2.5
Justification:
ECHA default: remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default: general population
AF for the quality of the whole database:
1
Justification:
high quality
AF for remaining uncertainties:
1
Justification:
ECHA dafault
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
DNEL value:
100 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 2-ethylhexanoic acid (2Et), i.e. expressed as mg 2Et/kg bw/day. The DNEL is given on a substance specific basis, i.e. expressed as "mg magnesium 2-ethylhexanoate/kg bw/day".

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default: rat
AF for other interspecies differences:
2.5
Justification:
ECHA default: remaining differences
AF for intraspecies differences:
10
Justification:
ECHA default: general population
AF for the quality of the whole database:
1
Justification:
high quality
AF for remaining uncertainties:
1
Justification:
ECHA default
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

In order to evaluate toxicological properties of the substance magnesium 2‑ethylhexanoate, information on the assessment entities magnesium cation and 2‑ethylhexanoate anion were considered. For a documentation and justification of that approach, please refer to the separate document attached to section 13, namely Read Across Assessment Report for magnesium 2‑ethylhexanoate.