Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.33 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.32 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation studies assessing the systemic toxicity of zinc bis(2-ethylhexanoate) are not available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments.

Reliable data available for the assessment entities zinc and 2-ethylhexanoic acid indicate that the moiety of toxicological concern is 2 -ethylhexanoic acid.

The toxicological hazard assessment is based on the most toxic moiety, i.e. 2 -ethylhexanoate anion, and the respective DNEL is recalculated for zinc bis(2-ethylhexanoate) based on a maximum 2 -ethylhexanoic acid content of 81.4 %.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
covering the entire duration of pregnancy
AF for interspecies differences (allometric scaling):
1
Justification:
not required for oral to inhalation extrapolation
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 key study
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:
2.46 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):
50
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Studies assessing systemic toxicity via the dermal route with zinc bis(2-ethylhexanoate) are not available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments.

Reliable data available for the assessment entities zinc and 2-ethylhexanoic acid indicate that the moiety of toxicological concern is 2 -ethylhexanoic acid.

The toxicological hazard assessment is based on the most toxic moiety, i.e. 2 -ethylhexanoate anion, and the respective DNEL is recalculated for zinc bis(2-ethylhexanoate) based on a maximum 2 -ethylhexanoic acid content of 81.4 %.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
covering the entire duration of pregnancy
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 key study
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:
low hazard (no threshold derived)

Additional information - workers

In order to evaluate toxicological properties of the substance zinc bis(2-ethylhexanoate), information on the assessment entities zinc 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 Report Read-across concept Category approach for zinc bis(2-ethylhexanoate).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.27 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):
25
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
86.96 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation studies assessing systemic toxicity of zinc bis(2-ethylhexanoate) are not available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments.

Reliable data available for the assessment entities zinc and 2-ethylhexanoic acid indicate that the moiety of toxicological concern is 2 -ethylhexanoic acid.

The toxicological hazard assessment is based on the most toxic moiety, i.e. 2 -ethylhexanoate anion, and the respective DNEL is recalculated for zinc bis(2-ethylhexanoate) based on a maximum 2 -ethylhexanoic acid content of 81.4 %.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
covering the entire duration of pregnancy
AF for interspecies differences (allometric scaling):
1
Justification:
not required for oral to inhalation extrapolation
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 key study
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:
1.23 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):
100
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Studies assessing systemic toxicity via the dermal route with zinc bis(2-ethylhexanoate) are not available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments.

Reliable data available for the assessment entities zinc and 2-ethylhexanoic acid indicate that the moiety of toxicological concern is 2 -ethylhexanoic acid.

The toxicological hazard assessment is based on the most toxic moiety, i.e. 2 -ethylhexanoate anion, and the respective DNEL is recalculated for zinc bis(2-ethylhexanoate) based on a maximum 2 -ethylhexanoic acid content of 81.4 %.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
covering the entire duration of pregnancy
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 key study
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:
1.23 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):
100
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Studies assessing systemic toxicity via the oral route with zinc bis(2-ethylhexanoate) are not available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments.

Reliable data available for the assessment entities zinc and 2-ethylhexanoic acid indicate that the moiety of toxicological concern is 2 -ethylhexanoic acid.

The toxicological hazard assessment is based on the most toxic moiety, i.e. 2 -ethylhexanoate anion, and the respective DNEL is recalculated for zinc bis(2-ethylhexanoate) based on a maximum 2 -ethylhexanoic acid content of 81.4 %.

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
1
Justification:
covering the entire duration of pregnancy
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 key study
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

In order to evaluate toxicological properties of the substance zinc bis(2-ethylhexanoate), information on the assessment entities zinc 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 Report Read-across concept Category approach for zinc bis(2-ethylhexanoate).