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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
12 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
304 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral study available - systemic effects
AF for dose response relationship:
1
Justification:
dose-response study available
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
already taken into account for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
standard factor for workers
AF for the quality of the whole database:
1
Justification:
several studies availabel on chelates
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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:
25 000 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
Modified dose descriptor starting point:
NOAEL
Value:
2 500 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral study available - systemic effects
AF for dose response relationship:
1
Justification:
dose-response study available
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
standard for worker
AF for the quality of the whole database:
1
Justification:
several studies available for chelates
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Definition of the point of departure:

The target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes, consists of several EDTA-components: EDTA-MnNa2 (30%), EDTA-FeNa (25%), EDTA-CuNa2 (9%), EDTA-ZnNa2 (9%) and EDTA-CoNa2 (<0.5%, i.e. Co2+<0.1%). Other components of the UVCB are water, Na2SO4 and MgSO4. It is not expected that the latter bear a higher hazard than the EDTA-compounds.

There are different studies with EDTA-ingredients of the target substance available for the derivation of a DNEL:

The available data on repeated dose toxicity via the oral route with structurally related source substances showed no adverse effects which are relevant for classification. The NOAEL for EDTA-MnNa2, which is included in the target substance to 30%, is 500 mg/kg bw/d and the NOAEL for EDTA-CuNa2, which is included in the target substance to 9%, is expected to be close to 150 mg/kg bw/d. For the other ingredients EDTA-FeNa (25%) and EDTA-ZnNa (9%) of the target substance the NOEAL is unknown, but it is expected that neither those substances nor its (physiological) iron - or zinc-countercations would not induce higher toxicity compared to the above mentioned substances. This is supported by the results of the repeated dose toxicity study with EDTA-FeNa, where the highest dose tested, 84 mg/kg bw/d, did not induce any adverse effects.

Therefore EDTA-CuNa2 is the ingredient of the target substance showing the lowest effect level, a LOAEL of 150 mg/kg bw/d. Based on the limited effects observed at 150 mg/kg bw/d, the NOAEL would be close to 150 mg/kg bw/d. Therefore an assessment factor of 3 is considered as worst-case assessment factor for LOAEL to NOAEL extrapolation. In addition, to reflect that the quantity of EDTA-CuNa2 in the target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes,is only 9%, the resulting extrapolated NOAEL is subsequently divided by 0.1 to derive the point of departure for subsequent DNEL derivation.

This results in the following point of departure:

POD=LOAEL/AF 3 (LOAEL to NOAEL)/percentage in target compound to reflect that target compound is a multicomponent substance (UVCB)

POD=150 mg/kg/3/0.1=500 mg/kg bw/d

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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
Modified dose descriptor starting point:
NOAEC
Value:
150 mg/m³
Explanation for the modification of the dose descriptor starting point:
oral study available - systemic effects
AF for dose response relationship:
1
Justification:
dose-response study available
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not needed for inhalation exposure
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
several studies available on chelates
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
DNEL related information

Local effects

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:
12 500 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
2 500 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral route available - systemic effects
AF for dose response relationship:
1
Justification:
dose-response study available
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
several studies available on chelates
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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:
2.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applicable (oral study available)
AF for dose response relationship:
1
Justification:
dose response study available
AF for differences in duration of exposure:
2
Justification:
subchornic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
standard factor
AF for the quality of the whole database:
1
Justification:
several studies on chelates available
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Definition of the point of departure:

The target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes, consists of several EDTA-components: EDTA-MnNa2 (30%), EDTA-FeNa (25%), EDTA-CuNa2 (9%), EDTA-ZnNa2 (9%) and EDTA-CoNa2 (<0.5%, i.e. Co2+<0.1%). Other components of the UVCB are water, Na2SO4 and MgSO4. It is not expected that the latter bear a higher hazard than the EDTA-compounds.

There are different studies with EDTA-ingredients of the target substanceavailable for the derivation of a DNEL:

The available data on repeated dose toxicity via the oral route with structurally relatedsource substancesshowed no adverse effects which are relevant for classification. The NOAEL for EDTA-MnNa2, which is included in the target substance to 30%, is 500 mg/kg bw/d and the NOAEL for EDTA-CuNa2, which is included in the target substance to 9%, is expected to be close to 150 mg/kg bw/d. For the other ingredients EDTA-FeNa (25%) and EDTA-ZnNa (9%) of the target substance the NOEAL is unknown, but it is expected that neither those substances nor its (physiological) iron - or zinc-countercations would not induce higher toxicity compared to the above mentioned substances. This is supported by the results of the repeated dose toxicity study with EDTA-FeNa, where the highest dose tested, 84 mg/kg bw/d, did not induce any adverse effects.

Therefore EDTA-CuNa2 isthe ingredient of the target substance showing the lowest effect level, a LOAEL of 150 mg/kg bw/d. Based on the limited effects observed at 150 mg/kg bw/d, the NOAEL would be close to 150 mg/kg bw/d. Therefore an assessment factor of 3 is considered as worst-case assessment factor for LOAEL to NOAEL extrapolation. In addition, to reflect that the quantity of EDTA-CuNa2 in the target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes,is only 9%, the resulting extrapolated NOAEL is subsequently multiplied by a factor of 10/divided by 0.1 to derive the point of departure for subsequent DNEL derivation.

This results in the following point of departure:

POD=LOAEL/AF 3 (LOAEL to NOAEL)/percentage in target compound to reflect that target compound is a multicomponent substance (UVCB)

POD=150 mg/kg/3/0.1=500 mg/kg bw/d