Tetrahydrofurfuryl methacrylate

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:

2006-12-19 to 2007-01-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guideline/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrofurfuryl methacrylate

EC Number:

219-529-5

EC Name:

Tetrahydrofurfuryl methacrylate

Cas Number:

2455-24-5

Molecular formula:

C9H14O3

IUPAC Name:

(oxolan-2-yl)methyl 2-methylprop-2-enoate

Method

Target gene:

his (Salmonella strains), trp (E. coli strain)

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:

S9 mix

Test concentrations with justification for top dose:

Experiment 1: 0, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
Experiment 2: 0, 156, 313, 625, 1250, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

with metabolic activation

Controls 2

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide

Remarks:

without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY
- Method: reduced bacterial growth

Evaluation criteria:

Although not given in the study report, according to OECD guideline 471 a test item is considered mutagenic if:
- a clear and dose-related increase in revertant number occurs
- a biologically relevant positive response for at least one dose group occurs: in TA 100 and E. coli uvrA number of revertants at least twice as high as in solvent control; TA 98, TA 1535, TA 1537 at least three times higher number of revertants as in solvent control

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

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
cytotoxic effects were observed in strains TA98, TA100, TA1535 and TA1537 at 5000 µg/plate without metabolic activation and in strains TA100 and TA1535 at 5000 µg/plate with metabolic activation

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

 

 

S9 mix	test item concentration [µg/plate]	mean number revertants/plate
		TA100	TA1535	E. coli WP2uvrA-	TA98	TA1537
without	0	117	12	28	10	5
	4.88	92	8	23	17	9
	19.5	99	10	23	13	7
	78.1	107	11	26	15	7
	313	91	12	23	16	4
	1250	109	10	20	17	5
	5000	80*	8*	28	11*	5*
	positive control	722	404	257	414	138
with	0	112	9	32	26	10
	4.88	105	12	33	23	15
	19.5	92	7	33	29	12
	78.1	111	9	30	26	7
	313	110	10	38	30	8
	1250	124	7	34	24	10
	5000	87*	11*	30	22	9
	positive control	1341	256	1017	421	124

 

S9 mix	test item concentration [µg/plate]	mean number revertants/plate
		TA100	TA1535	E. coli WP2uvrA-	TA98	TA1537
without	0	106	13	16	14	7
	156	113	14	24	12	4
	313	108	11	24	18	5
	625	88	15	21	18	10
	1250	110	13	20	12	7
	2500	114	20	18	16	7
	5000	65*	4*	18	10*	9*
	positive control	679	454	188	520	195
with	0	112	10	26	26	12
	156	109	5	28	21	11
	313	99	8	28	29	10
	625	104	7	30	26	11
	1250	112	11	36	22	10
	2500	110	12	33	21	12
	5000	99*	10*	37	25	12
	positive control	1311	276	981	426	132

 

* cytotoxic, reduced bacterial growth

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

THFMA was not mutagenic in the bacterial reverse gene mutation assay when tested up to cytotoxic or limit concentrations (5000 µg/plate).

Executive summary:

In a reverse gene mutation assay in bacteria similar to OECD guideline 471, S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 strains were exposed to THFMA in DMSO at concentrations of 0, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate in the first experiment and 0, 156, 313, 625, 1250, 2500, 5000 µg/plate in the second experiment in the presence and absence of mammalian metabolic activation (S9 mix).  THFMA was tested up to limit concentrations (5000 µg/plate).

Cytotoxic effects (reduced bacterial growth) were observed in strains TA98, TA100, TA1535 and TA1537 at 5000 µg/plate without metabolic activation and in strains TA100 and TA1535 at 5000 µg/plate with metabolic activation.

There was no evidence of induced mutant colonies over background. 

THFMA was not mutagenic in this bacterial reverse gene mutation assay when tested up to cytotoxic or limit concentrations (5000 µg/plate).

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.