Registration Dossier
Registration Dossier
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EC number: 269-049-5 | CAS number: 68186-87-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77347.
Toxicological Summary
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 in the substance dataset are in very good agreement with regards to the negligible level of bioavailability of the elements Co, Al and Zn contained in the pigment.
(1) In in-vitro dissolution experiments in five different artificial physiological media, dissolved Co, Zn and Al concentrations from this pigment were very low, corresponding to a solubility of less than 0.2 %.
(2) In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Al and Zn plasma and urine concentrations and only a small increase in Co plasma and urine concentrations was 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, cumulated relative amounts of merely < 0.003 % (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, 105% Al, 97.35% Co and 100.16% of the dose were excreted via faeces within 3 days, with only <0.01% 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 at 0.009% (Co), 0.14% (Al) and 0.077% (Zn) in relation to a mixture of soluble Al3+, Co2+and Zn2+compounds (Al2(SO4)3, CoCl2and ZnSO4)injected i.v..
Comparing the findings of in-vitro dissolution testing (1) with in-vivo results (2-4), the in-vivo data consistently demonstrate slightly lower bioavailability. This is in agreement with the general understanding thatin-vitroexperiments in simulated gastric juice provide a conservative estimate of actual (in-vivo) bioavailability.
In conclusion, the oral relative bioavailability of the pigment "Cobalt zinc aluminate blue spinel" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparably results supported by anin-vitrodissolution 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 (<<0.003% for all three metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.01% for Zn, <0.006% for Co and 0% 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 in the substance dataset are in very good agreement with regards to the negligible level of bioavailability of the elements Co, Al and Zn contained in the pigment.
(1) In in-vitro dissolution experiments in five different artificial physiological media, dissolved Co, Zn and Al concentrations from this pigment were very low, corresponding to a solubility of less than 0.2 %.
(2) In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Al and Zn plasma and urine concentrations and only a small increase in Co plasma and urine concentrations was 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, cumulated relative amounts of merely < 0.003 % (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, 105% Al, 97.35% Co and 100.16% of the dose were excreted via faeces within 3 days, with only <0.01% 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 at 0.009% (Co), 0.14% (Al) and 0.077% (Zn) in relation to a mixture of soluble Al3+, Co2+and Zn2+compounds (Al2(SO4)3, CoCl2and ZnSO4)injected i.v..
Comparing the findings ofin-vitrodissolution testing (1) within-vivoresults (2-4), thein-vivodata consistently demonstrate slightly lower bioavailability. This is in agreement with the general understanding thatin-vitroexperiments in simulated gastric juice provide a conservative estimate of actual (in-vivo) bioavailability.
In conclusion, the oral relative bioavailability of the pigment "Cobalt zinc aluminate blue spinel" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparably results supported by anin-vitrodissolution 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 (<<0.003% for all three metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.01% for Zn, <0.006% for Co and 0% for Al).
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