2-(dimethylamino)ethyl acrylate

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: GLP-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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(dimethylamino)ethyl acrylate

EC Number:

219-460-0

EC Name:

2-(dimethylamino)ethyl acrylate

Cas Number:

2439-35-2

Molecular formula:

C7H13NO2

IUPAC Name:

2-(dimethylamino)ethyl prop-2-enoate

Details on test material:

- Name of test substance: DIMETHYLAMINOETHYLACRYLAT
- Batch identification: Tank 20
- CAS No.: 2439-35-2
- Purity/composition: 99.9 peak area-%
- Storage stability: The stability of the test substance under storage conditions throughout the study period is guaranteed as indicated by the sponsor, and the sponsor holds this responsibility.
- Physical state, appearance: Liquid, colorless, clear
- Storage conditions: Refrigerator (protected from light)

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98, Escherichia coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

22 µg - 5500 µg/plate (SPT), 11 µg - 2750 µg/plate (PIT)

Vehicle / solvent:

- Vehicle used: water
- Justification for choice of vehicle: good solubility of the TS in water

Controls

Untreated negative controls:

yes

Remarks:

sterility control

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

With S-9: 2-AA (2.5 µg/plate: TA 1535, TA 100, TA 1537, TA 98; 60 µg/plate: E. coli WP2 uvrA). Without S-9: MNNG (5µg/plate: TA 1535, TA 100), NOPD (10 µg/plate: TA 98), AAC (100 µg/plate: TA 1537), 4-NQO (5 µg/plate: E. coli WP2 uvrA).

Details on test system and experimental conditions:

Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation were performed. The experimental procedure of the standard plate test (plate incorporation method) is based on the method of Ames et al., (1975) Mut. Res., 31, 347-364 and Maron and Ames (1983) Mut. Res., 113, 173-215. The experimental procedure of the preincubation test is based on the method described by Yahagi et al. (1977) Mut. Res., 48, 121 - 130 and Matsushima et al. (1980) In Norpoth and Garner, Springer Verlag Berlin, Heidelberg, New York.

1st Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA
- Doses: 0; 22; 110; 550; 2750 and 5500 µg/plate
- Vehicle: Water
- Type of test: Standard plate test with and without S-9 mix
- Number of plates: 3 test plates per dose or per control

2nd Experiment:
- Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA
- Doses: 0; 11; 55; 275; 1375 and 2750 µg/plate
- Vehicle: Water
- Type of test: Preincubation test with and without S-9 mix
- Number of plates: 3 test plates per dose or per control

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:

other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98, Escherichia coli WP2 uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

≥ 2750 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Standard plate test (SPT):

Dose/plate (µg)	Without S9 mix		With S9 mix (1:9)
	Mean	SD	Mean	SD
Salmonella typhimurium TA 1535
0 (Water)	15	2	16	2
22	15	1	14	2
110	16	4	14	3
550	14	3	14	4
2750	8	3	9	3
5500	1	1	6	2
MNNG 5.0 µg	572	39
2-AA 2.5 µg			130	19
Salmonella typhimurium TA 100
0 (Water)	107	3	107	7
22	101	12	107	6
110	101	9	100	7
550	82	16	99	6
2750	55	22	64	15
5500	21	4	23	11
MNNG 5.0 µg	647	23
2-AA 2.5 µg			725	69
Salmonella typhimurium TA 1537
0 (Water)	10	1	9	3
22	9	2	8	2
110	7	1	8	4
550	8	1	9	3
2750	7	2	5	2
5500	6	0	4	1
AAC 100.0 µg	342	28
2-AA 2.5 µg			115	13
Salmonella typhimurium TA 98
0 (Water)	26	3	35	3
22	27	1	34	3
110	25	5	30	5
550	21	2	33	4
2750	17	7	26	1
5500	4	2	17	1
NOPD 10.0 µg	539	26
2-AA 2.5 µg			620	38
Escherichia coli WP2 uvrA
0 (Water)	33	6	38	3
22	33	4	37	6
110	29	8	38	11
550	29	5	32	4
2750	22	6	22	2
5500	14	4	21	4
4-NQO 5.0 µg	587	16
2-AA 60 µg			239	13

 

Preincubation Test (PIT):

Dose/plate (µg)	Without S9 mix		With S9 mix (1:9)
	Mean	SD	Mean	SD
Salmonella typhimurium TA 1535
0 (Water)	16	1	17	3
11	15	3	15	2
55	15	4	15	5
275	14	3	15	3
1375	13	2	13	1
2750	9	1	10	3
MNNG 5.0 µg	755	77
2-AA 2.5 µg			109	3
Salmonella typhimurium TA 100
0 (Water)	114	9	123	10
11	117	13	109	7
55	106	11	121	3
275	115	9	99	5
1375	99	3	103	12
2750	73	3	81	15
MNNG 5.0 µg	787	14
2-AA 2.5 µg			1214	148
Salmonella typhimurium TA 1537
0 (Water)	10	1	10	3
11	8	4	10	2
55	9	3	10	4
275	8	2	7	3
1375	7	2	8	3
2750	3	2	4	2
AAC 100.0 µg	439	20
2-AA 2.5 µg			179	17
Salmonella typhimurium TA 98
0 (Water)	28	3	32	6
11	27	2	31	6
55	25	3	29	5
275	27	5	26	7
1375	23	5	20	6
2750	14	1	12	2
NOPD 10.0 µg	687	99
2-AA 2.5 µg			884	82
Escherichia coli WP2 uvrA
0 (Water)	29	2	38	5
11	30	8	33	5
55	31	3	36	7
275	29	6	33	6
1375	24	4	25	3
2750	16	2	18	3
4-NQO 5.0 µg	536	17
2-AA 60 µg			211	11

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here.