Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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