Registration Dossier
Registration Dossier
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EC number: 234-465-8 | CAS number: 12005-21-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The substance is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. Due the chemical nature of the substance only acid hydrolysis or similar decomposition methods would result in soluble matter.
Testing of the substance as a suspension is not in line with the guideline. Results produced with suspensions are usually not accepted by authorities.
The substance is not bioavailable for the bacterial cell in the Ames test or other in vitro test methods due to its insolubility. The substance is not capable of interfering with the genome in the bacterial cell. Hence, the Ames-test is negative as a basic principle.
The same applies for potential mutagenic activity under natural conditions.
Testing for genetic toxicity in vitro was aimed for but was technically not possible. REACH Annex XI no. 2: "Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance..."
Justification for selection of genetic toxicity endpoint
Both studies were selected.
Short description of key information:
The variations L181 and L175G25C4G were tested for genetic toxicity in vitro.
The substance is completely insoluble in water, DMSO, ethanol, acetone, tetrahydrofurane or isopropanol. It is not bioavailable for the bacterial cell.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Testing for genetic toxicity in vitro was aimed for but was technically not possible. REACH Annex XI no. 2: "Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the propertis of the substance..."
As discussed, the substance has to be considered as negative as regards genetic toxicity in vitro.
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.
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