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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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that only duplicate plates were used, and positive controls all required activation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
range of strains; duplicate not triplicate
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Alcohols, C12-13
EC Number:
278-306-0
EC Name:
Alcohols, C12-13
Cas Number:
75782-86-4
IUPAC Name:
dodecan-1-ol

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typrhimurium strains TA98, 100, 1535, 1537 and 1538; Escherichia coli strains WP2 and WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
0, 0.2, 2, 20, 200 (or 500 E. coli) and 2000 µg/plate

Results and discussion

Test results
Species / strain:
bacteria, other: Salmonella typrhimurium strains TA98, 100, 1535, 1537 and 1538; Escherichia coli strains WP2 and WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Remarks:
>2000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
PRECIPITATION CONCENTRATION: None reported
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

GENOTOXIC EFFECTS: 
- With and without metabolic activation: There was no increase in reverse  mutation rate in any of the test organisms. 

Table 1a Experiment 1 and 3* Plate incorporation: revertants per plate (mean of 2 plates)

Concentration µg/plate

E coli WP2

E coli WP2 uvrA

TA 100

TA 1535

-MA

+MA

-MA

+MA

-MA

+MA

-MA

+MA

0

9.8

10.3

9.55

17.5

38.8

47.0

7.0

4.0

0.2

13.3

9.3

7.8

19.0

46.3

55.8

10.3

4.8

2

12.3

11.0

7.5

18.5

46.0

52.0

5.5

5.0

20

9.5

9.8

7.3

15.8

48.0

55.0

6.5

3.8

200

11.8

7.5

13.5

13.5

44.3

56.8

12.5

.7.0

2000

11.5

18.0

6.8

3.5

49.8

60.0

8.5

10.0

Positive control

143.8

24.8

109.2

454.0

50.3

158.3

1122.0

1077.3

* Salmonella strains were tested in experiment 3, E.coli in experiment 1

 

Table 1b Experiment 3 Plate incorporation: revertants per plate (mean of 2 plates)

Concentration µg/plate

TA 1538

TA 98

TA 1537

-MA

+MA

-MA

+MA

-MA

+MA

0

7.8

11.0

7.3

13.5

7.8

5.8

0.2

3.8

11.0

4.0

12.3

6.8

6.5

2

4.8

9.8

5.8

14.5

5.5

4.8

20

3.8

11.0

6.5

12.8

6.8

6.3

200

5.0

12.8

7.5

10.8

10.0

12.3

2000

5.3

16.0

7.0

11.0

6.0

5.8

Positive control

4.3

47.8

6.0

144.8

8.3

12.8

 

 

Table 2a Experiment 2 and 4* Plate incorporation: revertants per plate (mean of 2 plates)

Concentration µg/plate

E coli WP2

E coli WP2 uvrA

TA 100

TA 1535

-MA

+MA

-MA

+MA

-MA

+MA

-MA

+MA

0

9.5

6.3

7.5

8.3

107.5

105.7

2.5

2.8

0.2

7.8

8.3

7.5

10.8

106.8

93.0

1.3

2.0

2

5.5

8.0

6.5

9.8

111.0

85.8

3.0

1.8

20

6.3

6.3

11.0

14.5

105.3

98.0

2.0

2.0

200

4.8

7.8

8.3

9.8

107.0

93.8

1.8

2.5

2000

5.8

7.3

7.5

10.8

101.8

95.0

0.8

1.5

Positive control

179

15.8

353.3

606

117.3

203.5

476.3

569.0

* Salmonella strains were tested in experiment 4 (TA 100 in experiment 5), E.coli in experiment 2

 

Table 2b Experiment 4 Plate incorporation: revertants per plate (mean of 2 plates)

Concentration µg/plate

TA 1538

TA 98

TA 1537

-MA

+MA

-MA

+MA

-MA

+MA

0

2.8

13.0

3.0

5.3

2.3

2.0

0.2

1.0

8.8

1.3

6.5

2.5

3.0

2

1.0

8.5

1.3

6.5

5.0

2.8

20

1.3

7.8

3.0

6.5

2.5

3.5

200

2.3

7.3

1.8

8.5

1.5

4.0

2000

1.5

3.8

0.3

7.8

2.5

2.3

Positive control

2.0

34.8

2.5

28.5

2.8

8.0




Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

The C12-13 alcohol Dobanol 23 has been tested according to OECD 471 and under GLP. The test substance did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium or E. coli in the presence or absence of metabolic activation at dose levels up to 2000 µg/plate. Vehicle and positive controls produced expected results. There was no evidence of cytotoxicity at any dose level.