Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Read-across of data for an analogous chemical. The target chemical and the source chemical are very closely related alkyl acrylate compounds. They differ only by the addition of a methyl group in the butyl portion of the molecule. Both molecules are expected to be metabolized via the same hydrolysis and enzymatic pathways. The data from the source chemical are experimental results from well documented studies which meet basic scientific principles and are considered to be acceptable with restrictions. Comparable to guideline with acceptable restrictions (dose level not up to cytotoxic range; 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:
1977
Report date:
1977

Materials and methods

Principles of method if other than guideline:
The study was conducted according to the method described by Ames (1975) with minor modifications.

Ames BN et al. (1975). Mut. Res. 31: 347-364
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Butyl acrylate
EC Number:
205-480-7
EC Name:
Butyl acrylate
Cas Number:
141-32-2
IUPAC Name:
butyl acrylate
Details on test material:
- Name of test material (as cited in study report): Butyl acrylate
- Physical state: liquid
- Analytical purity: approximately 99.6 %
- Impurities (identity and concentrations): 0.4% butylpropionate, 15 ppm methyletherhydroquinone

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:
Aroclor 1254 induced Sprague-Dawley-rat liver S-9 mix
Test concentrations with justification for top dose:
3.15 to 1000 nL per plate (2.84, 9.0, 28.4, 90.0, 283.5 and 900.0 µg per plate) Calculation (µg/plate) based on density of the test substance (0.9 g/mL).
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: with S9: 2-Aminoanthracene, Benzo(a)pyrene, 3-Methylcholanthrene and trans-N-Methyl-4-Aminostilbene; without S9: N-Methyl-N-Nitro-N-Nitrosoguanidine, Benzo(a)pyren-4-5-oxide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

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 number of revertants with metabolic activation

Test substances

Dose / plate (µg)

TA1535

TA1537

TA98

TA98 TCPO*

TA100

Butyl acrylate

2.84

35

23

68

50

138

9.0

27

26

64

56

107

28.4

27

30

60

61

124

90.0

28

32

61

65

123

283.5

22

25

52

54

130

900.0

26

23

56

54

112

Positive Control-1

3.15

-

-

245

308

387

6.3

231

96

1298

-

1550

10

519

58

-

-

1465

20

890

-

-

-

-

Positive Control-2

10

21

150

599

781

520

Positive Control-3

90

22

85

800

676

3495

Positive Control-4

10

-

-

-

-

448

Vehicle Control

21

24

49

62

110

- Not done

Positive Control-1: 2-Aminoanthracene

Positive Control-2: Benzo(a)pyrene

Positive Control-3: 3-Methylcholanthrene

Positive Control-4: trans-N-Methyl-4-Aminostilbene

* 60 nl of epoxide hydratase inhibitor (1,1,1 Trichloro- propene-2,3-oxide) was added to each plate dissolved in 10 µl DMSO

Mean number of revertants without metabolic activation

Test substances

Dose / plate (µg)

TA1535

TA1537

TA98

TA100

Butyl acrylate

2.84

19

10

11

97

9.0

13

14

16

149

28.4

16

12

18

140

90.0

20

8

11

130

283.5

25

9

16

126

900.0

21

11

15

135

Positive Control-1

1

903

7

19

232

3.15

8500

31

29

4250

10

31000

39

51

9250

Positive Control-2

2

17

572

3650

1060

Vehicle Control

19

8

15

117

- Not done

Positive Control-1: N-Methyl-N-Nitro-N-Nitrosoguanidine

Positive Control-2: Benzo(a)pyren-4-5-oxide

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

The results presented in this summary are experimental results for the source chemical n-butyl acrylate. The results are considered to be appropriate for read-across to the target chemical 2-methylbutyl acrylate.