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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial mutagenicity: 3-(triethoxysilyl)propyl methacrylate was negative with and without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli strains WP2 or WP2 uvrA (OECD 471) (Microbiological Associates, 1995).

Link to relevant study records
Reference
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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1993
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
histidine operon - Salmonella strains, tryptophan operon - E.coli strains
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
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:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
up to 5000 μg/plate

Vehicle / solvent:
100% ethanol
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Remarks:
WP2, WP2 uvrA; -MA; 1000 μg/plate
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: sterigmatocystin
Remarks:
WP2; +MA; 100 μg/plate
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA 1537; -MA; 75 μg/plate
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA 100, TA 1535; -MA; 1.0 μg/plate
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA 98; -MA; 1.0 μg/plate
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA 98, TA 100, TA 1535, TA 1537, WP2 uvrA; +MA; 1.0 μg/plate (10 μg/plate WP2 uvrA)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); pre-incubation

ACTIVATION:
S9 mix:
-10% S9
- 5mM glucose-6-phosphate
- 4 mM β-nicotinamide-adenine dinucleotide phosphate
- 8 mM MgCl2
- 33 mM KCl
in a 100 mM phosphate buffer at pH 7.4

0.5 ml S9 mix were added to 0.1 ml tester strain and 0.025 ml test article giving a final concentration of approximately 8% S9 during pre-incubation. 2.0 ml of top agar were added so the concentration of S9 in the plates was approximately 2%.

DURATION
- Preincubation period: 60±2 minutes at 37±2°C
- Exposure duration: 48 to 72 hours at 37±2°C

SELECTION AGENT (mutation assays): histidine or tryptophan-deficient agar plates

NUMBER OF REPLICATIONS: triplicate plates, independent repeat assays were performed. Pre-incubation was used in all assays.

DETERMINATION OF CYTOTOXICITY
- Method: other: condition of the bacterial background lawn
Evaluation criteria:
For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article.
Data sets for strains TA 1535 and TA 1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or great than three times the mean vehicle control value.
Data sets for strains TA 98, TA 100, WP2 uvrA and WP" were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value.
Key result
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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
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
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS

- Precipitation: No precipitation was observed.

RANGE-FINDING/SCREENING STUDIES: Results of initial toxicity studies were used to set doses in main study.

COMPARISON WITH HISTORICAL CONTROL DATA:
Experiment B1: toxicity in control plates +S9, and excessive toxicity in TA1535 -S9 were observed, so relevant parts repeated in B2.
Experiment B2: unacceptable positive control values obtained for: TA1535 -S9; TA1537 and WP2 +S9, so relevant parts repeated in B3.
Experiment B3: unacceptable vehicle control value obtained for TA1537 +S9; unacceptable positive control value obtained for WP2 +S9; excessive toxicity in TA1537 -S9, so relevant parts repeated in B5.
Experiment B4 (confirmatory assay): unacceptable positive control value obtained for WP2 +S9; erratic toxicity in WP2 -S9, so relevant parts repeated in B6
Experiments B5 and B6: results acceptable.
Remarks on result:
other: No mutagenic potential

The notation B1 -B6 in the tables indicates in which experiment the result was obtained.

Table 1 Initial experiment, without metabolic activation

Dose (µg)

TA 98 (B1)

TA 100 (B1)

TA 1535 (B1)

TA 1535 (B5)

TA 1535 (B3)

TA 1537 (B1)

WP2 uvrA (B1)

WP2 (B1)

0.0

21

121

10

10

28

5

292

91

1.0

 -

 -

 -

9

 -

 -

3.3

24

134

6

8

 -

5

 -

 -

10

25

143

7

6

28

5

 -

 -

33

18

105

11

9

25

3

285

94

100

16

62

6

8

6

3

213

85

333

9

4

4

8

6

0

180

91

1000

5

17

0

7

8

0

215

88

5000

11

39

0

9

8

0

272

85

Positive control

1342

746

541

549

349

460

1682

1550

 

Table 2 Initial experiment, with metabolic activation

Dose (µg)

TA 98 (B2)

TA 100 (B2)

TA 1535 (B2)

TA 1537 (B2)

TA 1537 (B5)

WP2 uvrA (B2)

WP2 (B2)

WP2 (B5)

0.0

36

135

28

5

5

368

109

109

1.0

 -

 -

 -

 -

8

108

3.1

30

120

28

6

 -

 -

 -

 -

3.3

 -

 -

 -

-

8

100

10

32

118

26

8

9

 -

 -

107

31

33

119

31

6

 -

346

90

 -

33

 -

 -

9

 -

 -

100

100

31

126

27

8

9

342

90

79

313

27

129

21

6

325

97

333

 -

 -

 -

 -

7

 -

 -

95

1000

30

117

18

5

3

323

84

102

5000

14

141

24

5

3

295

65

103

Positive control

144

431

410

2451

21

2231

1863

238

 

Table 3 Confirmatory experiment without metabolic activation

Dose (µg)

TA 98 (B4)

TA 100 (B4)

TA 1535 (B4)

TA 1537 (B4)

WP2 uvrA (B4)

WP2 (B4)

WP2 (B6)

0.0

15

111

7

5

193

29

52

1.0

 -

 -

 -

 -

55

3.3

22

105

10

3

 -

 -

57

10

14

107

6

5

160

21

38

33

19

102

8

4

191

26

48

100

14

90

7

4

205

24

50

333

10

75

7

2

225

16

54

1000

11

105

6

4

227

14

49

5000

4

75

6

4

224

27

47

Positive control

343

373

291

332

1679

798

1536

 

Table 4 Confirmatory experiment with metabolic activation

Dose (µg)

TA 98 (B4)

TA 100 (B4)

TA 1535 (B4)

TA 1537 (B4)

WP2 uvrA (B4)

WP2 (B6)

0.0

30

134

9

7

277

65

1.0

 -

 -

 -

61

3.3

 -

 -

 -

 -

62

10

25

115

6

5

295

57

33

26

122

8

4

300

66

100

24

130

6

5

315

60

333

13

104

10

5

307

62

1000

14

105

4

3

325

65

5000

15

111

12

4

241

67

Positive control

1049

1040

110

151

911

140

Conclusions:
3-(Triethoxysilyl)propyl methacrylate has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, compliant with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli strains WP2 or WP2 uvrA in the initial or the repeat experiments up to limit concentrations using pre-incubation. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

3-(Triethoxysilyl)propyl methacrylate has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, compliant with GLP (Microbiological Associates, 1995). No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli strains WP2 or WP2 uvrA in the initial or the repeat experiments up to limit concentrations using pre-incubation. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.

Justification for classification or non-classification

Based on the available bacterial mutagenicity study, no classification is required for 3-(triethoxysilyl)propyl methacrylate according to Regulation (EC) No 1272/2008.