Registration Dossier
Registration Dossier
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EC number: 701-417-7 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
The in-vitro and in-vivo experiments described in the dataset are in very good agreement with regards to the negligible level of bioavailability of the elements Cr and Sn contained in the pigment, indicating a lack of any concern for toxicity to reproduction properties.
(1) No signs of local toxicity in an acute inhalation toxicity test at the limit dose of 5.4 mg/L and no signs of mutagenic or clastogenic potential in three different genetic toxicity test systems could be observed.
The inhalation study has been performed according to OECD TG 403 and which shows no signs of acute toxicity after inhalation exposure to the pigment, indicating a LC50 > 5.4 mg/L. No mortality occurred.
(2) In in-vitro dissolution experiments in five different artificial physiological media, dissolved Cr and Sn concentrations from this pigment were very low, corresponding to a solubility of about 0.005% and 0.161%, respectively.
(3) In a 28-day oral toxicity study with 1,000 mg/kg pigment the uptake of Sn and Cr during 24 hour urine and plasma sampling period was demonstrated to be negligible considering that <<0.05 % of the dose was excreted via urine for both metals, mirrored by either minimal or no increase in blood plasma concentrations.
(4) In a mass balance study with a single oral dose of 1,000 mg/kg of the pigment, 91.6 % Cr, and 79.4 % Sn of the dose were excreted via urine and faeces during the first three days after exposure, with only <0.002 % of the dose being excreted via urine.
(5) In a relative bioavailability study, a relative bioavailability of approx. 0.43/1.17 % (males/females) and 0.05/0.25 % (males/females) was calculated for Cr and Sn, respectively, following treatment with the pigment.
In conclusion, the oral absolute and relative bioavailability of the pigment "Chromium tin calcium silicon sphene" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparable results, supported by in-vitro dissolution experiments in five different artificial physiological media.
A rounded value of <<0.05% 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 (<<0.05% for both metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.001% for Cr and 0.002 % for Sn).
It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Cr and Sn plasma concentrations were observed, and only a minor fraction (<0.001% and <0.002%) of the total administered dose of Cr and Sn was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.
Effects on developmental toxicity
Additional information
The in-vitro and in-vivo experiments described in the dataset are in very good agreement with regards to the negligible level of bioavailability of the elements Cr and Sn contained in the pigment, indicating a lack of any concern for toxicity to reproduction properties.
(1) No signs of local toxicity in an acute inhalation toxicity test at the limit dose of 5.4 mg/L and no signs of mutagenic or clastogenic potential in three different genetic toxicity test systems could be observed.
The inhalation study has been performed according to OECD TG 403 and which shows no signs of acute toxicity after inhalation exposure to the pigment, indicating a LC50 > 5.4 mg/L. No mortality occurred.
(2) In in-vitro dissolution experiments in five different artificial physiological media, dissolved Cr and Sn concentrations from this pigment were very low, corresponding to a solubility of about 0.005% and 0.161%, respectively.
(3) In a 28-day oral toxicity study with 1,000 mg/kg pigment the uptake of Sn and Cr during 24 hour urine and plasma sampling period was demonstrated to be negligible considering that <<0.05 % of the dose was excreted via urine for both metals, mirrored by either minimal or no increase in blood plasma concentrations.
(4) In a mass balance study with a single oral dose of 1,000 mg/kg of the pigment, 91.6 % Cr, and 79.4 % Sn of the dose were excreted via urine and faeces during the first three days after exposure, with only <0.002 % of the dose being excreted via urine.
(5) In a relative bioavailability study, a relative bioavailability of approx. 0.43/1.17 % (males/females) and 0.05/0.25 % (males/females) was calculated for Cr and Sn, respectively, following treatment with the pigment.
In conclusion, the oral absolute and relative bioavailability of the pigment "Chromium tin calcium silicon sphene" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparable results, supported by in-vitro dissolution experiments in five different artificial physiological media.
A rounded value of <<0.05% 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 (<<0.05% for both metals) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.001% for Cr and 0.002 % for Sn).
It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Cr and Sn plasma concentrations were observed, and only a minor fraction (<0.001% and <0.002%) of the total administered dose of Cr and Sn was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.
Justification for classification or non-classification
It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Cr and Sn plasma concentrations were observed, and only a minor fraction (<0.002%) of the total administered dose of Cr and Sn was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.
No classification for toxicity to reproduction according to EC Regulation No. 1272/2008 is anticipated.
Additional information
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