[No public or meaningful name is available]

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:

weight of evidence

Study period:

12 Apr - 17 Dec 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions (too less information on test material are available)

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Reference 2

Reference Type:

secondary source

Title:

Test Plan for the polyol esters category of the aliphatic esters chemicals

Author:

US-EPA (American Chemistry Council’s Aliphatic Esters Panel)

Year:

2004

Bibliographic source:

High Production Volume (HPV)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

too less information on test material are available

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

EC Number:

267-021-7

EC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Cas Number:

647028-25-9

Molecular formula:

Not available (UVCB)

IUPAC Name:

647028-25-9

Method

Target gene:

his operon and trp operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

33.3, 100, 333, 1000, 3330, and 5000 µg/plate of the test material (one experiment)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol (plating aliquot: 50 µL)

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2 aminoanthracene (2.5 or 25 µg/plate, S9+, TA100, TA1535, TA1537, WP2uvrA), benzo(a)pyrene (2.5 µg/plate, S9+, TA98)

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide (2.0 µg/plate, S9-, TA100 and TA1535), 2-nitrofluorene (1.0 µg/plate, S9-,TA98), 4-nitroquinoline-N-oxide (1.0 µg/plate, S9-, WP2uvrA), ICR-191 (2.0 µg/plate, S9-, TA1537)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 52 ± 4 hr

NUMBER OF REPLICATIONS: triplicates (one experiment)

DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or by thinning or disappearance of the bacterial background lawn

Evaluation criteria:

The test material was considered positive in this test system if the following criteria are met: for the test item to be considered mutagenic, at least two- (for tester strains TA98, TA 100, and WP2uverA) and/or three-fold (for tester strains TA 1535 and TA 1537) increases in mean revertants per plate over the mean reventants per plate of the appropriate vehicle control must be observed. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.

Statistics:

Mean values and standard deviations were calculated

Results and discussion

Test results

Test results 1

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:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not 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