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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
24 Apr 1980 - 23 Sep 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study report which meets basic scientific principles, acceptable with restriction. Neither Escherichia coli strain WP2 uvrA pKM101a nor S. typhimurium strain TA102 were employed in this study for the detection of oxidising mutagens and cross-linking agents.

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)
Principles of method if other than guideline:
Ames test (Ames et al., Mutation Research 31: 347, 1975)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl acrylate
EC Number:
205-438-8
EC Name:
Ethyl acrylate
Cas Number:
140-88-5
Molecular formula:
C5H8O2
IUPAC Name:
ethyl acrylate
Details on test material:
- Name of test material (as cited in study report): Ethyl acrylate
- Analytical purity: no data

Method

Target gene:
Histidin auxotrophy
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Liver from Aroclor 1254 pre-induced rats
Test concentrations with justification for top dose:
0.001, 0.01, 0.1, 1.0, and 5.0 µl/plate for strains TA1535, TA1537, TA98, and TA100
.
Test repeated with 1.0, 2.5, 5.0, 6.0, and 7.5 µl/plate for strain TA1535 and with 0.001, 0.01, 0.1, 1.0, and 5.0 µl/plate for TA 98.
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Anthramine (TA 1535, TA 1537, TA 100), 2-Acetamidofluorene (TA 98)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


NUMBER OF REPLICATIONS: 3


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth


Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Mean His (+) revertants/plate:

Main Test:

Concentration [µL/plate]

TA 1535

TA 1537

TA 98

TA 100

A

S

A

S

A

S

A

S

5.0

60.3*

39.3

21.7

11.0

37.0

21.3

89.7

93.3

1.0

46.7

39.0

26.0

8.7

57.7

12.0

96.3

88.7

0.1

34.7

37.7

26.0

9.3

136.7

25.7

100.0

115.7

0.01

35.0

48.7

26.7

10.7

137.7

23.7

110.7

112.7

0.001

35.3

42.7

29.7

10.3

135.0

25.3

93.0

104.3

DMSO

36.0

41.9

24.4

11.3

141.4

22.7

100.2

98.8

2-AA

223

41.0

361.8

13.5

434.7

81.8

2-AAF

693.2

15.2

Retest 1:

Concentration [µL/plate]

TA 98

A

S

5.0

51.0

11.7

1.0

48.7

22.7

0.1

50.7

21.7

0.01

60.0

25.7

0.001

57.3

22.0

DMSO

52.8

23.1

2-AA

2-AAF

2366.8

24.3

Retest 2:

Concentration [µL/plate]

TA 1535

A

S

7.5

19.7

25.3

6.0

17.3

20.0

5.0

23.3

28.7

2.5

30.0

17.0

1.0

24.3

24.0

DMSO

21.5

26.3

2-AA

420.2

28.2

2-AAF

A: Liver fromAroclor 1254 pre-induced rats

S: Saline-buffer control mixture

2-AA: 2-Anthramine (10 µg/plate)

2-AAF: 2-Acetaamidofluorene (50 µg/plate)

* difference between the number of revertants at the test concentration and the solvent control is significant; p 0.05

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative