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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Principles of method if other than guideline:
Plate incorporation assay with six doses tested in four Salmonella strains (TA98, TA100, TA1535, TA1537) and E. coli WP2 (uvrA).
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Zeolite S-D (H-Mordenite)
- Chemical name: Zeolite, silica rich, crystalline, synthetic, non-fibrous
- Framework: orthorhombic
- Related CAS number: 1318-02-1
- Analytical purity: no data

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535 and TA 1537, and E. coli WP2 (uvrA)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9-mix contained 10% v/v S9 from male Sprague-Dawley rats induced by PB and BF
Test concentrations with justification for top dose:
0.156, 0.313, 0.625, 1.25, 2.5 and 5 mg/plate
Vehicle / solvent:
diluted in distilled water with sonication
Controls
Untreated negative controls:
not specified
Remarks:
(vehicle control used as negative control)
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9 mix: AF-2 (TA100: 0.01, TA98: 0.1, and E. coli WP2: 0.01 μg/plate), ENNG (TA1535: 5 μg/plate), ICR-191 (TA1537: 1 μg/plate); +S9mix: 2-aminoanthracene for all strains (AF-2: 1, TA1535: 2, WP2: 20, TA98: 0.5, TA1537: 2 μg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours at 37 °C
- Expression time (cells in growth medium): 16 hours

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: Yes

DETERMINATION OF CYTOTOXICITY
- Method: observed but no information of method

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1535 and TA 1537, and E. coli WP2 (uvrA)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
There were no increased incidence of reverse mutations observed in all tester strains when compared to controls. H-Mordenite was found to be non-mutagenic in this assay. The positive controls gave appropriate responses.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1. Mean colony number per plate

 

Concentration (μg/ plate)

TA100

TA1535

WP2uvrA

TA98

TA1537

S9 Mix

(-)

Control

204

16

20

12

9

156

156

16

20

10

6

313

192

15

19

8

6

625

200

16

18

10

7

1250

188

21

24

17

9

2500

212

22

22

18

15

5000

188

26

26

20

16

S9 Mix

(+)

Control

176

10

15

30

6

156

174

12

18

30

8

313

136

10

19

30

4

625

152

10

18

28

8

1250

154

12

17

22

10

2500

186

12

12

24

10

5000

160

15

20

26

6

Positive control

(S9-)

 

AF-2

0.01 μg/ plate

ENNG

5 μg/ plate

AF-2

0.01 μg/ plate

AF-2

0.1 μg/ plate

ICR-191

1 μg/ plate

470

105

226

329

394

Positive control

(S9+)

 

2-AA

1 μg/ plate

2-AA

2 μg/ plate

2-AA

20 μg/ plate

2-AA

0.5 μg/ plate

2-AA

2 μg/ plate

340

234

444

245

120

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative