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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Additional information

Bacterial Reverse Mutation Assay- The study was conducted in accordance with OECD guidelines 471. All criteria for a valid study were met. Under the condition of this study EC 903-162-9 did not cause a positive mutagenic response with any of the tester strains in either the presence or absence of Aroclor-induced rat liver S9. The study was concluded to be negative.

Mouse Lymphoma Assay-The study was conducted in accordance with the OECD 476 guidelines. All criteria for a valid study were met. Under the condition of this study, test article EC 903-162-9 was concluded to be Negative in the L5178Y/TK+/- Mouse Lymphoma Mutagenesis Assay.

Mammalian chromosome Aberration Test- The study was conducted in accordance with the OECD guidelines 473. No significant increase in structural and numerical chromosome aberrations in the test material-treated groups relative to the respective solvent controls in both the presence and absence of the S9 metabolic activation system was observed. The percentages of aberrant cells in the test material-treated groups were within the historical solvent control range. The results for the positive and negative controls indicate that all criteria for valid assay were met. The cytotoxicity and chromosome aberration data of the untreated control were comparable to that of the diluent for all treatment conditions. The study was concluded to be negative. The study is being used as read across from EC 903-161-3 to EC 903-162-9. Justification for use of this read across is provided in IUCLID section 13. The negative result for genetic toxicity for EC 903-161-3 is considered representative of the genetic toxicity potential for EC 903-162-9.


Short description of key information:
Negative for mutagenicity in bacterial cultures in short term in vitro tests (OECD 471)
Negative for induction of structural and numerical chromosome aberrations (OECD 473)
Negative for gene mutation in mouse lymphoma cells (OECD 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All results for genotoxic potential, in prokaryotic and eukaryotic (including mammalian) species were negative. Therefore, in accordance with EC Regulation 1272/2008, no classification is required.