Registration Dossier
Registration Dossier
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EC number: 267-029-0 | CAS number: 67762-64-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Under the tested experimental conditions the read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)- 1,3-propanediol octanoate did not induce gene mutations in S. typhimurium strains and in an E. coli strain up to the maximum limit of solubility. Therefore it is not considered to be mutagenic in this bacterial mutagenicity test.
Read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, did not induce chromosomal aberrations in CHO cells after in vitro treatment with and without metabolic activation, under the reported experimental conditions.
Read-across substance, fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane, does not induce mutation at the TK locus of L5178Y mouse lymphoma cells in vitro in the absence or presence of S9 metabolic activation, under the reported experimental conditions.
The read-across substance, fatty acids, C5-10, esters with pentaerythritol, was not mutagenic in the in vivo mammalian erythrocyte micronucleus test both with and without metabolic activation.
In conclusion, by read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate, is not considered to be mutagenic.
Justification for selection of genetic toxicity endpoint
Three in vitro studies and 1 in vivo study were conducted with read-across substances. The results of all 4 studies were negative therefore one study has not been selected.
Short description of key information:
By read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate, is not considered to be mutagenic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
By read-across, the above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for genetic toxicity is therefore required.
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