Registration Dossier
Registration Dossier
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EC number: 930-991-3 | CAS number: -
Genetic toxicity: in vitro
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:
- 1 989
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 substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- 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
Constituent 1
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
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