Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

An Ames test test with Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid is not available. In the key study the similar substance Reaction mass of n-undecanoic acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and tester strain E. coli WP2 uvrA. The study was designed to be compliant with OECD Guideline No. 471 and in accordance with the OECD Principles of Good Laboratory Practices.

In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. Toxic effects of the test item were noted in all tester strains used in experiment I and II. In experiment I toxic effects of the test item were observed at concentrations of 1.0 µL/plate and higher with and without metabolic activation depending on the particular tester strain. In experiment II toxic effects of the test item were noted at concentrations of 0.316 µL/plate and higher with and without metabolic activation, depending on the particular tester strain.

No biologically relevant increases in revertant colony number of any of the five tester strains were observed following treatment with the test substance.

Therefore, the test substance was considered to be non-mutagenic in this bacterial reverse mutation assay.

In a second supporting study with the analogue substance 2-butyloctanoic acid, the test item was examined for mutagenic activity by assaying for reverse mutation in Salmonella typhimurium, strains TA1535, TA1537, TA98, TA100 and TA102. Experiments were performed both in the absence and presence of metabolic activation. The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism. It was concluded that 2-butyloctanic acid did not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.


Short description of key information:
An Ames test with Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid is not available. In a reliable GLP compliant bacterial reverse mutation assay conducted according to OECD 471 guidelines the similar substance Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid was reported to be negative for mutagenic activity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The similar substance Reaction mass of n-undecanoic acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid

was considered to be non-mutagenic in this bacterial reverse mutation assay.

Consequently Reaction mass of 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid is not classified for genotoxicity under the Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).