Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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).