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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Alkylate 215
IUPAC Name:
Alkylate 215
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, 1000, 3000, and 10000 μg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
9-aminoacridine
2-nitrofluorene
benzo(a)pyrene
other: sodium nitrite
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
Key result
Species / strain:
S. typhimurium, other: 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
True negative controls validity:
not applicable
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.

Any other information on results incl. tables

Table 1: Mean Revertants/plate - without S9

Concentration (μg 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

Table 2: Mean Revertants/plate - with S9

Concentration (μg 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:
Under the conditions described in this study Alkylate 215 did not show mutagenic properties.
Executive summary:

This EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test) and GLP compliant study was performed to investigate 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 μg/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.