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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.48 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):
50
Dose descriptor starting point:
NOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
24 mg/m³
Explanation for the modification of the dose descriptor starting point:

4 mg/kg bw/day × (10 m3/person/day /60 kg bw/person) × (100% oral absorption/100% inhalation absorption)

AF for dose response relationship:
1
Justification:
NOAEL defined
AF for differences in duration of exposure:
2
Justification:
Default- subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required for inhalation
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
2
Justification:
Limited human data
AF for remaining uncertainties:
2.5
Justification:
default- remaining differences
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:
0.32 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):
50
Dose descriptor starting point:
NOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

4 mg/kg bw/day × (100% oral absorption/25% dermal absorption)

AF for dose response relationship:
1
Justification:
NOAEL defined
AF for differences in duration of exposure:
2
Justification:
Default - subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required - the starting point NOAEL is for humans
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
2
Justification:
Limited human data
AF for remaining uncertainties:
2.5
Justification:
default- remaining differences
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:
high hazard (no threshold derived)

Additional information - workers

The repeat dose oral toxicity of the test material was evaluated first by using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the Organic Functional Group category, and the results were refined using relevant subcategories.

Based on the modelled conditions, the subacute NOEL of the test material in the rat was determined to be ca. 7.8 mg/kg bw/day.

The target chemical falls within the applicability domain of the prediction.

 

However, according to an EFSA opinion (please refer to Section 13 for more information), ZN-100, also known as zinc L-pidolate, is used as a food supplement.

Once in the body ZN-100 will dissociate into its components i.e. L-pidolic acid and zinc.

According to EFSA a daily intake of L-pidolic acid of 3 g/day in humans is of no safety concern. This value corresponds to 50 mg/kg bw/day of L-pidolic acid or 62 mg/kg bw/day of zinc L-pidolate (ZN-100). 

Nevertheless, based on the Scientific Committee on Food (please refer to Section 13 for more information), a clear NOAEL for zinc is established at 50 mg/day for humans, which corresponds to a human NOAEL of 4 mg/kg bw/day for ZN-100.

This was used as the starting point for DNEL derivation and is considered protective enough for workers.

The substance is not a skin irritant or a skin sensitiser, but it does cause eye damage based on the results of an in vivo eye irritation study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 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):
100
Dose descriptor starting point:
NOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
36 mg/m³
Explanation for the modification of the dose descriptor starting point:

4 mg/kg bw/day × 6.7 m3/person/day /60 kg bw/person × (100% oral absorption/100% inhalation absorption)

AF for dose response relationship:
1
Justification:
NOAEL defined
AF for differences in duration of exposure:
2
Justification:
Default - subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required for inhalation
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
2
Justification:
Limited human data
AF for remaining uncertainties:
2.5
Justification:
default- remaining differences
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:
0.16 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):
100
Dose descriptor starting point:
NOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
16 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

4 mg/kg bw/day × (100% oral absorption/25% dermal absorption)

AF for dose response relationship:
1
Justification:
NOAEL defined
AF for differences in duration of exposure:
2
Justification:
Default - subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required - the starting point NOAEL is for humans
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
2
Justification:
Limited human data
AF for remaining uncertainties:
2.5
Justification:
default- remaining differences
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:
0.04 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):
100
Dose descriptor starting point:
NOAEL
Value:
4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral NOAELhuman= 4 mg/kg bw/day

AF for dose response relationship:
1
Justification:
NOAEL defined
AF for differences in duration of exposure:
2
Justification:
Default -subchronic to chromic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scalling is required - the starting point NOAEL is for humans
AF for other interspecies differences:
1
Justification:
Addressed by modification of starting point
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
2
Justification:
Limited human data
AF for remaining uncertainties:
2.5
Justification:
Default - remaining differences
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

The repeat dose oral toxicity of the test material was evaluated first by using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the Organic Functional Group category, and the results were refined using relevant subcategories.

Based on the modelled conditions, the subacute NOEL of the test material in the rat was determined to be ca. 7.8 mg/kg bw/day.

The target chemical falls within the applicability domain of the prediction.

 

However, according to an EFSA opinion (please refer to Section 13 for more information), ZN-100, also known as zinc L-pidolate, is used as a food supplement.

Once in the body ZN-100 will dissociate into its components i.e. L-pidolic acid and zinc.

According to EFSA a daily intake of L-pidolic acid of 3 g/day in humans is of no safety concern. This value corresponds to 50 mg/kg bw/day of L-pidolic acid or 62 mg/kg bw/day of zinc L-pidolate (ZN-100). 

Nevertheless, based on the Scientific Committee of Food (please refer to Section 13 for more information), a clear NOAEL for zinc is established at 50 mg/day for humans, which corresponds to a human NOAEL of 4 mg/kg bw/day for ZN-100.

This was used as the starting point for DNEL derivation and is considered protective enough for the general population.

The substance is not a skin irritant or a skin sensitiser, but it does cause eye damage based on the results of an in vivo eye irritation study.