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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified

Additional information - workers

The in-vitro and in-vivo experiments described above are in very good agreement with regards to the negligible level of bioavailability of the elements Al and Mn contained in the pigment.

(1)   In in-vitro dissolution experiments in five different artificial physiological media, dissolved Mn and Al concentrations from this pigment were below 820 μg/L and 230 μg/L even at the highest loading of 0.1 g/L, corresponding to a solubility of less than 1.1 %,

(2)   In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Al and Mn plasma and urine concentrations were observed when sampled at the end of the 28-day exposure period. From a final dose of 1,000 mg/kg of the pigment that the animals received on the last day of the study, only cumulated relative amounts of < 0.002 % (m/f) were found in the terminal 24-h urine collection period.

(3)   In a mass balance study with a single oral dose of 1,000 mg/kg of the pigment, 95.5 % Al, and 144 % Mn of the dose were excreted via faeces within 3 days, with only <0.005 % of the dose being excreted via urine at the same time.

(4)   In a relative bioavailability study, the relative bioavailability of orally administered pigment was calculated 0.09 % (Al) and 0.07 % (Mn) in relation to a mixture of soluble Al3+and Mn2+compounds (Al2(SO4)3, MnSO4) injected i.v..

Comparing the findings of in-vitro dissolution testing (1) with in-vivo results (2-4), the in-vivo data consistently demonstrates slightly lower bioavailability. This is in agreement with the general understanding that in-vitro experiments in simulated gastric juice provide a conservative estimate of actual (in-vivo) bioavailability.

In conclusion, the oral relative bioavailability of the pigment "Manganese alumina pink corundum" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparably results supported by an in-vitro dissolution experiment in five different artificial physiological media.

A rounded value of <0.01 % for oral absorption can be taken forward from (i) terminal urine/plasma sampling in a study involving 28 repeated oral doses of 1,000 mg pigment/kg bw/d (<<0.002 % for both metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.004 % for Mn and 0.0002 % for Al).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

The in-vitro and in-vivo experiments described above are in very good agreement with regards to the negligible level of bioavailability of the elements Al and Mn contained in the pigment.

(1)   In in-vitro dissolution experiments in five different artificial physiological media, dissolved Mn and Al concentrations from this pigment were below 820 μg/L and 230 μg/L even at the highest loading of 0.1 g/L, corresponding to a solubility of less than 1.1 %,

(2)   In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Al and Mn plasma and urine concentrations were observed when sampled at the end of the 28-day exposure period. From a final dose of 1,000 mg/kg of the pigment that the animals received on the last day of the study, only cumulated relative amounts of < 0.002 % (m/f) were found in the terminal 24-h urine collection period.

(3)   In a mass balance study with a single oral dose of 1,000 mg/kg of the pigment, 95.5 % Al, and 144 % Mn of the dose were excreted via faeces within 3 days, with only <0.005 % of the dose being excreted via urine at the same time.

(4)   In a relative bioavailability study, the relative bioavailability of orally administered pigment was calculated 0.09 % (Al) and 0.07 % (Mn) in relation to a mixture of soluble Al3+and Mn2+compounds (Al2(SO4)3, MnSO4) injected i.v..

Comparing the findings of in-vitro dissolution testing (1) within-vivoresults (2-4), the in-vivo data consistently demonstrates slightly lower bioavailability. This is in agreement with the general understanding that in-vitro experiments in simulated gastric juice provide a conservative estimate of actual (in-vivo) bioavailability.

In conclusion, the oral relative bioavailability of the pigment "Manganese alumina pink corundum" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparably results supported by an in-vitro dissolution experiment in five different artificial physiological media.

A rounded value of <0.01 % for oral absorption can be taken forward from (i) terminal urine/plasma sampling in a study involving 28 repeated oral doses of 1,000 mg pigment/kg bw/d (<<0.002 % for both metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.004 % for Mn and 0.0002 % for Al).