3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

Limited experimental information given. Cited in IUCLID dataset for CAS No. 7434-40-4. Data were unpublished proprietary information reported by business company to ECB for inclusion into IUCLID database.

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Principles of method if other than guideline:

Ames study conducted generally according to recognized methodology both with and without metabolic activation. Only 2 replicates were plated per test. Current OECD 471 guidelines require evaluation using 5 different strains.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Oxybis(ethane-2,1-diyloxyethane-2,1-diyl) bisheptanoate

EC Number:

274-829-3

EC Name:

Oxybis(ethane-2,1-diyloxyethane-2,1-diyl) bisheptanoate

Cas Number:

70729-68-9

Molecular formula:

C22H42O7

Specific details on test material used for the study:

Test material purity was 88% with remainder comprised of 6% triethylene glycol di-n-heptanoate, 4% mixed ester of tetraethylene glycol with n-heptanoic and 2 methylhexanoic acids, 2% other mixed esters.

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver preparations (S9 mixture)

Test concentrations with justification for top dose:

500-10,000 μg/plate, 100-2500 μg/plate (based on toxicity with TA1535)

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-Aminoanthrcene

Details on test system and experimental conditions:

Procedure: Plate incorporation test similar to OECD 471 procedure with independent repeat.

Statistics:

Z-test based on Poisson distribution

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test substance was not mutagenic, with or without metabolic activation in the Salmonella/Mammalian Microsome Reverse Mutation assay.