Methyl non-2-enoate

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:

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

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: 111. Results From the Testing of 255 Chemicals

Author:

Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, Kristien Mortelmans, and William Speck

Year:

1987

Bibliographic source:

Environmental Mutagenesis Volume 9, Supplement 9:1-110

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mention below

Principles of method if other than guideline:

To evaluate the mutagenic potential of N-Hexyl Methacrylate in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 by AMES test.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-methyl-, hexyl ester

Cas Number:

142-09-6

Molecular formula:

C10H18O2

IUPAC Name:

2-Propenoic acid, 2-methyl-, hexyl ester

Details on test material:

Details on test material
- Name of test material (as cited in study report): N-Hexyl Methacrylate
- Molecular formula: C10H18O2
- Molecular weight: 170.2502 g/mol
- Substance type: Organic

Specific details on test material used for the study:

Details on test material
- Name of test material (as cited in study report): N-Hexyl Methacrylate
- Molecular formula: C10H18O2
- Molecular weight: 170.2502 g/mol
- Substance type: Organic

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable.

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

not specified

Metabolic activation:

with and without

Metabolic activation system:

The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared

Test concentrations with justification for top dose:

0,100-10000µg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: -S9:sodium azide (TA1535 and TA l00), 9-aminoacridine (TA97 and TA 1S37), and 4-nitro-o phenyl ene diamine (TA98). +S9 2-aminoanthracene for all strains.

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: Preincubation Method

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 2 days


NUMBER OF REPLICATIONS: Triplicate

OTHER: At least five doses of the chemical were tested in triplicate

Rationale for test conditions:

Not specified

Evaluation criteria:

A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials.

Statistics:

Standard deviation was observed.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: strains TA98, TA100, TA1535, and 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:

Not specified

Remarks on result:

other: No mutagenic effect were observed.

Any other information on results incl. tables

: N-HEXIL METHACRYLATE  IM:CWRSOLVENT:DMSO

Dose	TA100 NA                    10%HLI          10% RLI                                          (-)                      (-)                          (-)						TA535 NA                    10%HLI          10% RLI                                          (-)                      (-)                          (-)						TA537 NA                    10%HLI          10% RLI                                          (-)                      (-)                          (-)						TA98 NA                    10%HLI          10% RLI (-)                      (-)                          (-)
µg/PLATE 0.000	mean 195	SEM 6.9	mean 190	SEM 5.1	mean 201	SEM 9.7	mean 23	SEM 1 . 7	mean 26	SEM 0.3	mean 23	SEM    0.7	mean   7	SEM 1.3	mean 17	SEM          2.1	Mean18	SEM    0.6	mean 30	SEM 2.4	mean 51	SEM 2.7	mean 43	SEM 2.3
0.100													7	0.9
0.330													8	1.7
1.000													7	1.2					27	2.3
3.000	194	11.0					22	1.7					5	0.7					29	4.7
10.000	208	3.8					25	1.2					4	1.7					24	2.6
33.000	182	14.6					30	0.9					t						24	3.0	46	4.8	40	3.9
100.000	189	11.6	184	13.6	203	13.6	29	1.7	30	1.0	25	26	t		22	0.3	18	0.7	29	3.9	4.6	3.8	43	2.6
333.000	t		194	14.7	199	6.1	t		22	3.2	24	0.3			19	3.8	19	2.1			44	3.5	33	3.8
1000.000			208	18.0	193	12.1			23	1.2	25	0.3			17	1.2	16	18	42		42	3.5	43	0.9
3333.000			196	14.4	198	9.6			23	2.7	21	2.2			24	2.0	20	0.9	37		42	3.5	43	0.9
10000.000			166	17.0	149	6.4			19	2.8	19	0.9			13	0.9	14	0.9			37	4.3	33	3.1
POS	1441	81.6	2077	244.2	1780	302.2	73346	42.4	755	122.2	523	55.8	216	50.7	55.8	39.7	434	68.5	215	17.1	1178	187.9	885	65.0

Applicant's summary and conclusion

Conclusions:

N-Hexyl Methacrylate(142-09-6) was evaluated for its mutagenic potential in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 by AMES test. The test result was considered to be negative in the presence and absence of S9.

Executive summary:

N-Hexyl Methacrylate was assessed for its possible mutagenic potential. For this purpose AMES test was performed on Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537. The test material was exposed at the concentration of 100-10000µg/plate in the presence and absence of S9. No mutagenic effects were observed. Therefore N-Hexyl Methacrylate was considered to be non mutagenic in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.