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Diss Factsheets

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:
experimental study
Adequacy of study:
key study
Study period:
1983-05-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it is GLP compliant and comparable to OECD guideline 471 and OPPTS 870.5100.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
Method: other: Simialr to OPPTS 870.5100
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Dodecane-1-thiol (CAS # 112-55-0)
IUPAC Name:
Dodecane-1-thiol (CAS # 112-55-0)
Details on test material:
dodecane-1-thiol
purity: Assumed 100%

Method

Species / strain
Species / strain / cell type:
other: Strains 1535, 1537, 1538, TA98, TA100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
10,000, 3333, 1111, 370.4, 123.5 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Remarks:
Bacteria only, S-9 Fraction
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Remarks:
MNNG, 9-AA, 2-NF
Details on test system and experimental conditions:
IUCLID4 Type: Salmonella typhimurium reverse mutation assay
Evaluation criteria:
Positive response requires a minimum two-fold increase in revertants compared with solvent control over three dose levels with appropriate response in positive and negative controls.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, 100, 1535, 1537, and 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Additional information on results:
No increase in reversion rates occurred over the dose range tested.
Remarks on result:
other: other: TA98, 100, 1535, 1537, and 1538
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Without activation:

Treatment

Dose level (µg/mL

No. of cells analyzed

Total no. of SCE’s

No. of SCE’s/cell

P value

Fold inc. in SCE’s/cell

No. chromosomes analyzed

No./ SEC’s/chromosome

P Value

Fold inc. in SCE’s/chromosome

Media control

-

50

456

9.10

-

-

997

.46

-

-

DMSO

-

50

437

8.74

-

-

1002

.44

-

-

EMS

400

50

998

19.96

.0000

2.2

997

1.00

.0000

2.2

n-Dodecyl mercaptan

10

50

408

8.16

.13

.9

986

.41

.19

.9

3.3

50

387

7.74

.03

.9

968

.39

.05

.9

1.0

50

412

8.24

.16

.9

1006

.41

.15

.9

.3

50

458

9.36

.13

1.1

998

.47

.10

1.1

.2

50

484

9.68

.05

1.1

983

.50

.02

1.1

With activation:

Treatment

Dose level (µg/mL

No. of cells analyzed

Total no. of SCE’s

No. of SCE’s/cell

P value

Fold inc. in SCE’s/cell

No. chromosomes analyzed

No./ SEC’s/chromosome

P Value

Fold inc. in SCE’s/chromosome

Media control

-

50

476

9.52

-

-

998

.48

-

-

DMSO

-

50

449

8.98

-

-

995

.45

-

-

CP

1.4

50

1122

22.44

.0000

2.4

997

1.13

.0000

2.4

n-Dodecyl mercaptan

10

50

423

8.46

.21

.9

984

.43

.23

1.0

3.3

50

501

10.02

.03

1.1

985

.51

.02

1.1

1.0

50

455

9.30

.28

1.0

1000

.46

.32

1.0

.3

50

443

8.86

.42

1.0

997

.45

.45

1.0

.1

50

461

9.22

.34

1.0

993

.47

.31

1.1

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under these conditions, n-dodecyl mercaptan did not exhibit a positive response and is considered not to be mutagenic in this test system.
Executive summary:

In a bacterial reverse mutation assay, strains 1535, 1537, 1538, TA98, and TA100 cultured in vitro were exposed to dodecane-1-thiol in DMSO at concentrations of 123.5, 374.4, 1111, 3333, 10,000 μg/mL in the presence and absence of S-9 mammalian metabolic activation.

 

Dodecane-1-thiol was tested up to 10,000 μg/mL, as this represented the limit of solubility. Exposure to five graded doses of dodecane-1-thiol in the presence and in the absence of metabolic activation did not increase the reversion to histidine prototrophy of S. typhimurium strains 1535, 1537, 1538, TA98 or TA100. Under these conditions the experimental dodecane-1-thiol did not exhibit a positive response and is not considered to be mutagenic in this test system. The positive controls did induce the appropriate response. 

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is GLP compliant and comparable to the guideline study.