2-Propanol, 1,3-bis(2,6-dimethylphenoxy)-

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

Study period:

2004-01-12 to 2004-03-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(2,6-dimethylphenoxy)propan-2-ol

EC Number:

617-745-8

Cas Number:

856976-65-3

Molecular formula:

C19 H24 O3

IUPAC Name:

1,3-bis(2,6-dimethylphenoxy)propan-2-ol

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:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20 µg - 5000 µg/plate - corresponds to 16.72 µg - 4180 µg/plate active ingredient (dose levels the Standard Plate Test)
4 µg - 2500 µg/plate - corresponds to 3.344 µg - 2090 µg/plate active ingredient (dose levels for Preincubation Test)

Vehicle / solvent:

Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine and 4-nitroquinoline-N-oxide

Details on test system and experimental conditions:

Standard Plate Test and Preincubation Test both with and without metabolic activation
METHOD OF APPLICATION: Standard plate test based on the method of Ames et al. + Preincubation test based on the method described by Yahagi et al. and Matsushima et al.

DURATION
- Preincubation period: 20 minutes using a shaker
- Exposure duration: 48 - 72 hours

DETERMINATION OF CYTOTOXICITY
Toxicity detected by a
- decrease in the number of revertants
- clearing or diminution of the background Iawn (= reduced his- or trp- background
growth)
- reduction in the titer
is recorded for all test groups both with and without S-9 mix in all experiments and
indicated in the tables.

Evaluation criteria:

The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system. A test substance is generally considered nonmutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

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:

other: A weak bacteriotoxic effect was observed under all test conditions.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Precipitation of the test substance was found from about 500 µg/plate onward.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

   

  

Strain	TA1535
S9-Mix			Without	With
	Dose/Plate (µg)		Revertants
		DMSO	16	16
		20	19	16
		100	15	13
		500	17	16
		2500	15	12
		5000	12	6
MNNG		5	1216
2-AA		2.5		114

 

Strain	TA1537
S9-Mix			Without	With
	Dose/Plate (µg)		Revertants
		DMSO	9	11
		20	8	7
		100	8	8
		500	6	6
		2500	3	3
		5000	3	3
MNNG		5	484
2-AA		2.5		140

 

Strain	TA100
S9-Mix			Without	With
	Dose/Plate (µg)		Revertants
		DMSO	112	109
		20	113	121
		100	110	111
		500	94	106
		2500	84	63
		5000	74	48
MNNG		5	1065
2-AA		2.5		1146

 

Strain	TA98
S9-Mix			Without	With
	Dose/Plate (µg)		Revertants
		DMSO	27	32
		20	29	36
		100	30	30
		500	24	21
		2500	15	16
		5000	9	12
MNNG		5	758
2-AA		2.5		931

 

Strain	E.coli
S9-Mix			Without	With
	Dose/Plate (µg)		Revertants
		DMSO	32	31
		20	29	27
		100	28	28
		500	26	26
		2500	24	22
		5000	17	18
4-NQO		5	669
2-AA		60		218