Benzoic acid, 4-[(1-oxodecyl)oxy]-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, 4-[ (1-oxodecyl) oxy]-

EC Number:

617-941-3

Cas Number:

86960-46-5

Molecular formula:

C17H24O4;

IUPAC Name:

Benzoic acid, 4-[ (1-oxodecyl) oxy]-

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital / β-Naphtoflavone induced rat liver S9-Mix

Test concentrations with justification for top dose:

16, 50, 160, 500, 1600, 5000 µg/plate
CONTROLS: Untreated controls with double distilled water were tested.
SOLVENT CONTROLS: Controls with DMSO were tested

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: - S9: ICR 191 (TA 1537), 4-Nitro-o-phenylenediamine (TA 98), Nitrofurantoine (TA 100), Sodium azide (TA 1535), 4-Nitroquinolin-1-oxid (E. coli WP2uvrA) / +S9: 2-Aminoanthracene (TA 1537, TA 100, TA 1535, E. coli WP2uvrA), Benzo(a)pyrene (TA 98)

Evaluation criteria:

The test item is to be classified mutagenic if there is a concentration effect relationship over at least three concentrations and / or the induction rate is ≥ 2

Statistics:

For evaluation of the results the induction rate of the mean values was calculated:

Induction rate = (revertant colonies of test item) / (revertant colonies of the ecorresponding control)

Arithmetic mean values and standard deviations were calculated out of colonies per plate of three replicates. Induction rates of the mean values were calculated out of the relation of revertant colonies of control and test item plates.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Mutagenic and Cytotoxic Effects of the Test Item

Strain	S9	Tested Concentration Range (factor √10) [mg/plate]		Lowest Mutagenic Concentration [mg/plate]	Lowest Cytotoxic Concentration [mg/plate]
					Plate Incorporation Method	Preincubation Method
TA 1537	-	5.0 - 0.05	1.6 – 0.016	none	1.6	0.5
	+				1.6	1.6
TA 98	-		5.0 - 0.05		> 5.0	0.5
	+				> 5.0	> 5.0
TA 100	-				5.0	0.5
	+				5.0	5.0
TA 1535	-				1.6	0.5
	+				> 5.0	> 5.0
E. coliWP2 (uvrA)	-				> 5.0	> 5.0
	+				> 5.0	> 5.0

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test item is regarded to be not mutagenic under test conditions.

Executive summary:

The mutagenic effects of the test item DOBA were determined in a bacterial reverse mutation test according to OECD Guideline No. 471 for Testing of Chemicals (1997) / Directive 2000/32/EC Method B. 13/14 (2000) in two independent studies (plate incorporation method and preincubation method). Test systems were the Salmonella typhimurium strains TA 1537, TA 98, TA 100 and TA 1535 and Escherichia coli WP2 (uvrA) with (+) and without (-) the metabolic activation system S9 (from male Wistar rats), respectively. Positive and negative controls were included in each study. The test item was dissolved in DMSO and applied once at test initiation with the concentration ranges as given in Table 1 (Mutagenic and Cytotoxic Effects of the Test Item). Duration of each study was 48 - 72 h.

Mutagenic and cytotoxic effects are summarized in Table 1 (Mutagenic and Cytotoxic Effects of the Test Item).

The test item is regarded to be not mutagenic under test conditions.