Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-102-2 | CAS number: 68187-50-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77498.
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The target substance showed minor dissolution of Fe in artificial gastric fluid after 2 h and 24 h incubation (94.2 ± 6.7 µg/L and 639 ± 166 µg/L respectively). No dissolved iron was detected in artificial sweat solution. Dissolution of Co was observed in artificial sweat after 2 h (31.3 ± 1.25 µg/L) and after 24 h (66.1 ± 6.66 µg/L). In artificial gastric fluid, Co was detected after 2 h (94.4 ± 4.18 µg/L) and after 24 h (362 ± 89.6 µg/L). In total, dissolution of Fe and Co is very low. Therefore, the pigment shows minor bioavailability in biological media.
Key value for chemical safety assessment
Additional information
A study was conducted with the objective to investigate the dissolution of the test item in the artificial physiological media GST (Artificial gastric fluid, pH = 1.5) and ASW (Artificial sweat solution, pH = 6.5). The test media were selected to simulate relevant human-chemical interactions, i.e. a substance entering the human body by ingestion or by inhalation. For the experimental setup the test item was weighed into flasks, adjusted to volume with the respective artificial physiological medium (loading of approx. 100 mg/L) and agitated. Samples were taken after 2 h and 24 h. The total dissolved iron and cobalt concentrations of sampled solutions were determined after filtration by ICP-OES.The test followed the experimental conditions of the OECD 29 guidance: 24 h agitation at 100 rpm inside an incubated laboratory shaker. The temperature in the thermostatically controlled incubation cabinet was adjusted to 37.5°C to obtain a temperature of 37 ± 2°C in the media to simulate the temperature of the human body.
The test item showed minor dissolution of Fe in artificial gastric fluid after 2 h and 24 h incubation (94.2 ± 6.7 µg/L and 639 ± 166 µg/L respectively). No dissolved iron was detected in artificial sweat solution. Dissolution of Co was observed in artificial sweat after 2 h (31.3 ± 1.25 µg/L) and after 24 h (66.1 ± 6.66 µg/L). In artificial gastric fluid, Co was detected after 2 h (94.4 ± 4.18 µg/L) and after 24 h (362 ± 89.6 µg/L) (Fraunhofer IME, 2017).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
