Registration Dossier
Registration Dossier
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EC number: 906-484-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Three GLP-compliant in vitro tests with reaction mass of DIPE and 2-methylpent-2-ene, a bacterial reverse mutation assay (Ames test), a mammalian chromosome aberration test, and a mammalian cell gene mutation test, were conducted.
The reported data of the bacterial reverse mutation assay show that under the experimental conditions applied, the substance did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
In the mammalian chromosome aberration test, the substance did not induce structural chromosome aberrations in this test in Chinese Hamster lung cells, both with and without metabolic activation. In the mammalian cell gene mutation test, the substance did not induce gene mutations in presence and absence of metabolic activation in the cultured mammalian cells (L5178Y TK+/- 3.7.2 C mouse lymphoma cell line) used.
Hence, in all three different tests, the gene toxicity of reaction mass of DIPE and 2-methylpent-2-ene was evaluated "negative". The substance can be regarded as not mutagenic.
These results are corroborated by literature data / study results for the main component DIPE:
The results of two Ames tests lead to the conclusion that diisopropyl ether did not induce reverse mutations either in the presence or absence of S9 metabolic activation under the experimental conditions described (1, 2).
Furthermore, in an in vitro mammalian cell gene mutation test, the test item diisopropyl ether did not induce gene mutations in presence and absence of metabolic activation in the cultured mammalian cells (L5178Y mouse lymphoma cell line) used (3).
References:
(1) Brooks TM, MeyerAL& Hutson DH (1988) The genetic toxicology of some hydrocarbon and oxygenated solvents. Mutagenesis, 3, 3, 227-232 (1988)
(2) Shell Research Limited (1985) GENOTOXICITY STUDIES WITH ISOPROPYL ETHER. Shell Research Limited (Environmental and Biochemical Toxicology Division), Sittingbourne Research Centre Report No. SBGR.85.029
(3) Toxi-Coop Zrt. in Balatonfüred Hungary (2010) IN VITRO MAMMALIAN CELL GENE MUTATION TEST (L5178Y/TK+/- MOUSE LYMPHOMA ASSAY) WITH diisopropyl ether. Toxi-Coop Zrt. Arácsi út 97. 8230 Balatonfüred Hungary, Report No. 590.734.2135
Short description of key information:
The genetic toxicity of reaction mass of DIPE and 2-methylpent-2-ene has been assessed in 3 GLP compliant in vitro studies, including a bacterial reverse mutation assay, a mammalian chromosome aberration test and a mammalian cell gene mutation test. Negative results were reported in all studies in the presence and/or absence of metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The criteria for classification as mutagenic were not met.
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