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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study published in peer-reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Composition of test material, percentage of components: <1% C9, 22% C10, 43% C11, 35% C12, 1% C13, <1% C14; average C11.26
- Analytical purity: 98.5%

Method

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:
S9 from Aroclor induced rat and mouse livers
Test concentrations with justification for top dose:
10, 40, 200, 1,000, 3,000, and 10,000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine, sodium nitrite, benzo(a)pyrene, 2-acetylaminofluorene, 2-nitrofluorene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
Evaluation criteria:
A response was considered positive if three or more treatments were significantly greater than controls, and if there was a significant dose response.
Statistics:
Significant differences analyzed using Bartlett's test. Comparison to controls analyzed using Dunnett's t test. Dose response analyzed with regression analysis for a log-log straight line and t test.

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:
valid
Positive controls validity:
valid
Additional information on results:
Negative with and without activation. A significant difference was seen in strain TA 98 with S9 at all concentrations. There was also a significant response in strain TA 1535 without S9 at a single concentration. Retesting with strain TA 98 showed no significant increase in revertants. A retest of strain TA 1535 was also negative. Due to lack of a dose-response relationship and lack of reproducibility of the positive results, the test substance is considered negative for mutagenicity.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Mean Revertants/plate - without S9

Concentration (ug or nl/plate)

TA 1535

TA 100

TA 1537

TA 98

First run

10

28.3 ± 3.51

307 ± 51.5

8.0 ± 1.0

25.7 ± 5.13

40

23.0 ± 2.65

344 ± 33.5

9.0 ± 3.6

19.3 ± 5.51

200

29.0 ± 8.00

310 ± 17.6

10.7 ± 0.58

17.3 ± 3.79

1000

23.3 ± 3.21

318 ± 33.3

10.0 ± 1.0

18.7 ± 1.15

3000

34.7 ± 5.03

296 ± 57.4

9.0 ± 1.7

21.7 ± 2.08

10,000

27.3 ± 4.62

297 ± 59.2

10.3 ± 1.5

27.3 ± 6.03

Solvent control

21.7 ± 0.58

395 ± 30.8

7.3 ± 3.5

23.7 ± 0.58

NaNO2

691

9-aminoacridine

1620

2-nitrofluorene

627

354

Second run

10

321 ± 17.7

40

297 ± 25.1

200

292 ± 39.0

1000

307 ± 20.3

1500

16.0 ± 1.0

3000

14.3 ± 0.58

322 ± 58.2

4000

12.0 ± 4.0

10,000

322 ± 33.2

Solvent control

13.0 ± 3.46

258 ± 25.5

NaNO2

564

2-nitrofluorene

814

Third run

10

245 ± 11.5

40

236 ± 30.7

200

166 ± 57.6

1000

203 ± 49.2

3000

230 ± 11.8

10,000

179 ± 22.3

Solvent control

233 ± 27.0

2-nitrofluorene

506

Mean Revertants/plate - with S9

Concentration (ug or nl/plate)

TA 1535

TA 100

TA 1537

TA 98

First run

10

25.7 ± 5.8

309 ± 44.9

11.3 ± 1.5

72.7 ± 5.8

40

21.3 ± 5.8

294 ± 31.0

10.3 ± 2.3

79.3 ± 5.5

200

20.3 ± 1.2

283 ± 12.7

7.3 ± 2.5

63.7 ± 13.9

1000

24.3 ± 2.1

339 ± 38.4

6.7 ± 1.5

71.7 ± 16.0

3000

22.7 ± 3.8

303 ± 27.4

13.7 ± 2.5

71.7 ± 4.2

10,000

28.7 ± 4.9

367 ± 62.4

12.3 ± 3.2

70.7 ± 0.53

Solvent control

24.3 ± 1.5

314 ± 20.3

9.7 ± 2.1

29.0 ± 9.5

B(a)P

938

459

2-AA

661

155

Second run

10

15.7 ± 3.2

280 ± 46.6

27.3 ± 2.5

40

11.0 ± 3.6

299 ± 15.0

33.7 ± 4.9

200

15.3 ± 2.1

294 ± 24.4

39.0 ± 1.0

1000

21.3 ± 3.1

297 ± 26.8

30.0 ± 7.2

3000

21.0 ± 11.5

301 ± 39.9

32.0 ± 7.2

10,000

13.7 ± 2.5

296 ± 6.8

36.0 ± 4.6

Solvent control

13.7 ± 5.7

304 ± 29.0

27.0 ± 1.7

B(a)P

1611

2-AA

511

896

Third run

10

191 ± 43.0

40

210 ± 3.06

200

227 ± 15.0

39.0 ± 6.2

250

35.3 ± 9.3

1000

229 ± 12.9

32.0 ± 5.3

3000

238 ± 29.7

10,000

204 ± 12.2

Solvent control

219 ± 39.8

34.7 ± 3.2

B(a)P

1649

810

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Alkylate 215 was not mutagenic in the Ames test.
Executive summary:

This test determined the mutagenicity of the test substance alkylate 215. Salmonella typhimurium strains TA 1535, TA 100, TA 1537, and TA 98 were exposed to concentrations of 10, 40, 200, 1,000, 3,000, and 10,000 ug/plate of test substance. DMSO was used as a solvent. 9-aminoacridine, sodium nitrite, benzo(a)pyrene, 2 -acetylaminofluorene, and 2 -nitrofluorene were used as positive controls substances. No reproducible, dose-response related positive results were seen in the treatment groups. A significant increase in revertants per plate was seen in the positive controls. The test substance is not mutagenic.