Octadecyl stearate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Gene mutation toxicity study of the test chemical

Author:

Zeiger et al

Year:

1985

Bibliographic source:

Environmental Mutagenesis

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Bacterial reverse mutation assay was performed for the test chemical using Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 with and without metabolic activation system

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Di(tridecyl) phthalate

EC Number:

204-294-3

EC Name:

Di(tridecyl) phthalate

Cas Number:

119-06-2

Molecular formula:

C34H58O4

IUPAC Name:

Ditridecyl phthalate

Details on test material:

- Name of test material: Ditridecyl phthalate
- Molecular formula: C34H58O4
- Molecular weight: 530.8282 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

Liver homogenates (S-9 fraction) from Aroclor 1254-induced male Sprague-Dawley rats (RLI) or male Syrian hamsters (HLI)

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3333, 10000 µg / plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: The chemical was soluble in acetone

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Acetone

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylenediamine (for TA98; without S9) and 2-amino-anthracene (2 AA; with S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: All tests were repeated atleast once

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

A mutagenic response was defined as a reproducible, dose-related increase in the number of histidine-independent colonies over the spontaneous incidence; there was no requirement for a specific magnitude of increase.

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA100, TA1535, TA98, TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data

RANGE-FINDING/SCREENING STUDIES: The final dose level selection was based on the results of a preliminary range-finding study conducted with TA100 in the presence and absence of S-9.

COMPARISON WITH HISTORICAL CONTROL DATA: No data

ADDITIONAL INFORMATION ON CYTOTOXICITY: No data

Remarks on result:

other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

The test chemical did not induce mutation in the Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 with and without rat and hamster liver S9 mix and hence the chemical is negative for gene mutation in vitro.

Executive summary:

Bacterial reverse mutation assay was performed for the test chemical using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 with and without rat and hamster liver S9 mix. The study was performed using the preincubation protocol at five dose from 0, 100, 333, 1000, 3333, 10000µg / plate with acetone as the solvent control with incubation period of 48 hrs in the presence and absence of S9 mix.The final dose level selection was based on the results of a preliminary range-finding study conducted with TA100 in the presence and absence of S-9. No mutagenic response was noted for the test compound in the preliminary dose range finding study and the main study performed. The test chemical did not induce mutation in the Salmonella typhimurium strain TA100, TA1535, TA98, TA1537 with and without rat and hamster liver S9 mix and hence the chemical is negative for gene mutation in vitro.