Diundecyl phthalate, branched and linear

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From September 2009 to October 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Experimental studies reported in peer reviewed journal. For read-across justification see Section 13.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diundecyl phthalate

EC Number:

222-884-9

EC Name:

Diundecyl phthalate

Cas Number:

3648-20-2

Molecular formula:

C30H50O4

IUPAC Name:

diundecyl benzene-1,2-dicarboxylate

Details on test material:

- Name of test material (as cited in study report): Diundecyl phthalate
- Lot/batch No.:Not stated
- Purity: Not stated

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:

S9

Test concentrations with justification for top dose:

A maximum dose-level of 10000 ug/plate (unless limited by solubility of toxicity) and four lower concentrations separated by half-log intervals

Vehicle / solvent:

Solvent used: No data

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Strains TA100 and TA1535; -S9

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Strain TA1537; -S9

Controls 3

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

Strain TA98; -S9

Controls 4

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

All strains; +S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; Preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

SELECTION AGENT (mutation assays): Histidine

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: Not reported but usually by reduced number of spontaneous revertants, microcolony formation, thinning of background lawn

Evaluation criteria:

For the test item to be considered mutagenic, a dose-related increase in revertant numbers must be observed.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

It is concluded that the substance does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.

Executive summary:

A bacterial reverse mutaion assay (Ames test) has been undertaken using methods similar to or equivalent to OECD test methods.

The substance does not induce reverse mutation in Salmonella typhimuriumi.