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Registration Dossier
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EC number: 235-790-8 | CAS number: 12737-27-8
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 below are in very good agreement with regards to the negligible level of bioavailability of the elements Cr and Fe contained in the pigment.
(1) In in-vitro dissolution experiments in five different artificial physiological media, dissolved Cr and Fe concentrations were below 18 µg/L even at the highest loading of 0.1g/L, corresponding to a solubility of 0.018 %.
(2) In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Cr and Fe 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 < 0.0025 % (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, 89.1% Cr, and 94.1% Fe of the dose were excreted via faeces within 3 days, with only <0.0024% 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 0.05% (Cr) in relation to a soluble Cr3+compound (Cr3(OH)2(CH3COO)7)injected i.v..
Comparing the findings ofin-vitrodissolution testing (1) within-vivoresults (2-4), thein-vivodata consistently demonstrates 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 "Chromium iron oxide" 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 (<<0.008% for both metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.00009% for Cr, and <0.0024% for Fe).
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 below are in very good agreement with regards to the negligible level of bioavailability of the elements Cr and Fe contained in the pigment.
(1) In in-vitro dissolution experiments in five different artificial physiological media, dissolved Cr and Fe concentrations were below 18 µg/L even at the highest loading of 0.1 g/L, corresponding to a solubility of 0.018 %.
(2) In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Cr and Fe 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 < 0.0025 % (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, 89.1% Cr, and 94.1% Fe of the dose were excreted via faeces within 3 days, with only <0.0024% 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 0.08% (Cr) in relation to a soluble Cr3+compound (Cr3(OH)2(CH3COO)7)injected i.v..
Comparing the findings ofin-vitrodissolution testing (1) within-vivoresults (2-4), thein-vivodata consistently demonstrates 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 "Chromium iron oxide" 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 (<<0.008 % for both metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.00009 % for Cr, and <0.0024 % for Fe).
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