Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

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:

18.9.1981 to 2.12.1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

- 2-Aminoanthracene was the only compound used to test the efficacy of the S9 mix; no independent repeat

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

EC Number:

253-039-2

EC Name:

Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]

Cas Number:

36443-68-2

Molecular formula:

C34H50O8

IUPAC Name:

ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]

Method

Target gene:

his/trp

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

5, 10, 50, 100, 500, 1000, and 5000 µg/0.1 mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO.
- Justification for choice of solvent/vehicle: Test article was soluble at >= 5% in DMSO.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other:

Remarks:

See Table 1.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: Incubated for about 48 hours at 37 ºC in darkness.

NUMBER OF REPLICATIONS: 3 petri dishes/strain/group

Evaluation criteria:

When the colonies had been counted, the arithmetic mean was calculated. The test substance is generally considered to be non-mutagenic if the colony count in relation to the negative control is not doubled at any concentration.

Statistics:

When the colonies had been counted, the arithmetic mean was calculated. No statistical analysis was performed.

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 500 µg/0.1 mL and above the substance precipitated in soft agar.

Any other information on results incl. tables

In the experiments performed without and with microsomal activation, comparison of the number of histidine- or tryptophan-prototrophic mutants in the controls and after treatment with TK 12627 revealed no marked differences. The slight increase in the number of back-mutants observed in the experiment without activation on strain TA 1537 at the concentrations of 10 and 5000 µg/0.1 mL is attributed to fluctuations in the rate of spontaneously occurring back-mutants.

EXPERIMENTAL RESULTS

	TA 98		TA 100		TA 1535		TA 1537		TA 1538		WP2uvrA
Dose (µg/0.1 ml)	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
solvent control	33	41	174	156	19	19	6	10	21	40	21	26
5	32	64	144	146	16	11	7	7	17	35	23	25
10	29	62	161	147	12	11	12	8	24	41	20	26
50	31	45	167	142	17	12	6	10	19	40	17	27
100	33	42	152	153	15	7	9	8	23	35	17	24
500	24	52	152	156	12	12	7	13	21	33	20	28
1000	26	47	163	152	15	9	7	8	20	39	15	34
5000	15	38	157	153	12	18	12	8	22	26	13	24
positive controls:
solvent control	40	62	174	152	17	14	10	11	17	37	18	21
concentration A	249	160	2496	221	464	152	67	70	350	96	409	874
concentration B	394	277	593	277	42	431	606	157	707	160	1346	992

Applicant's summary and conclusion

Conclusions:

In the experiments performed without and with microsomal activation, comparison of the number of histidine- or tryptophan-prototrophic mutants in the controls and after treatment revealed no marked differences.