Decanoic acid, mixed esters with neopentyl glycol and octanoic acid

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 based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

01 Mar - 11 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions (no analytical purty reported; no E.coli strain tested)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted in 1983

Deviations:

yes

Remarks:

no analytical purty reported; no E.coli strain tested

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane

EC Number:

306-523-3

EC Name:

Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane

Cas Number:

97281-24-8

IUPAC Name:

97281-24-8

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Analytical purity: no data

Method

Target gene:

his operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

First and second experiment: 8, 40, 200, 1000 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Tween 80 / water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: With and Without S9: sodium azide (2 µg/plate) for TA100 and TA1535; 9-aminoacridine (80 µg/plate) for TA1537; 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538. With and without S9: 2 aminoanthracene (2-AA; 2.5 or 5 µg/plate) for all strains

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: triplicates each in two independent experiments

Evaluation criteria:

The test material was considered positive in this test system if the following criteria were met:
- The plate background from the non revertant bacteria showed no growth reduction in comparison to the correspondent negative control.
- The spontaneous mutation rate of the strains tested was within the characteristic range of the spontaneous mutation.
- The positive controls showed mutation rates that exceeded the control values of the TA100 at least by a factor 2.0 and the other tester strains, at least by a factor 3.0.
- For the test item, two-fold increases in mean revertant numbers were observed at more then one dose level in TA 100. For the other strains, an increase in the mutation rate greater than three-fold in comparison to the correspondent negative control was observed.

Statistics:

Mean values and standard deviation were calculated.

Results and discussion

Test results

Test results 1

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:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Test Results of Experiment 1 (plate incorporation)

With or without S9-Mix

Test substance concentration (μg/plate)

Mean number of revertant colonies per plate (average of 3 plates)

Base-pair substitution type

Frameshift type

TA 100

TA1535

TA1538

TA98

TA1537

–

0

70.3 ± 8.7

8.6 ± 1.8

15.3 ± 2.2

15.8 ± 5.8

7.8 ± 1.1

–

8

70.3 ± 9.2

6.0 ± 1.7

6.0 ± 1.0

15.3 ± 3.7

3.0 ± 1.0

–

40

73.6 ± 6.3

8.3 ± 2.0

5.3 ± 1.5

14.6 ± 1.5

5.3 ± 2.5

–

200

77.0 ± 5.2

9.0 ± 1.0

6.0 ± 2.6

12.6 ± 3.2

5.0 ± 1.7

–

1000

71.6 ± 2.0

8.3 ± 1.1

8.6 ± 1.5

13.3 ± 1.5

7.0 ± 2.6

–

5000

78.6 ± 13.0

5.0 ± 1.7

7.6 ± 2.8

11.0 ± 4.0

3.3 ± 1.1

Positive controls, –S9

Name

NaA

2AA

NaA

2AA

4NOPD

2AA

4NOPD

2AA

9AA

2AA

Concentrations (μg/plate)

2.0

5.0

2.0

2.5

40.0

5.0

40.0

5.0

80

2.5

Mean No. of colonies/plate (average of 3)

235 ± 30.6

69.6 ± 1.5

255.3 ± 24.8

6.3 ± 0.57

844.0 ± 54.6

9.6 ± 4.7

370.0 ± 14.7

16.6 ± 3.5

146.0 ± 9.6

4.6 ± 1.5

+

0

83.5 ± 11.5

10.5 ± 2.5

14.5 ± 2.0

20.8 ± 3.9

7.6 ± 0.51

+

8

76.3 ± 2.0

9.6 ± 1.1

14.0 ± 3.0

17.6 ± 3.5

5.3 ± 2.5

+

40

74.6 ± 5.6

8.3 ± 1.1

13.6 ± 1.5

15.3 ± 1.5

6.3 ± 2.5

+

200

82.6 ± 0.57

10.0 ± 1.0

12.6 ± 2.8

19.6 ± 0.6

5.6 ± 3.0

+

1000

90.3 ± 5.5

13.6 ± 4.7

11.3 ± 3.2

19.6 ± 6.1

7.3 ± 3.2

+

5000

80.3 ± 16.1

12.6 ± 1.5

9.0 ± 1.7

22.3 ± 3.7

7.6 ± 0.6

Positive controls, + S9

Name

NaA

2AA

NaA

2AA

4NOPD

2AA

4NOPD

2AA

9AA

2AA

Concentrations (μg/plate)

2.0

5.0

2.0

2.5

40.0

5.0

40.0

5.0

80

2.5

Mean No. of colonies/plate (average of 3)

125.3 ± 9.6

1292.6 ± 100.4

44.0 ± 8.8

223.6 ± 47.0

793.6 ± 50.0

441.0 ± 49.3

450.0 ± 32.0

643.3 ± 137.3

61.6 ± 2.8

75.6 ± 7.5

Table 2: Test Results of Experiment 2 (plate incorporation)

With or without S9-Mix

Test substance concentration (μg/plate)

Mean number of revertant colonies per plate (average of 3 plates)

Base-pair substitution type

Frameshift type

TA 100

TA1535

TA1538

TA98

TA1537

–

0

90.0 ± 6.8

9.5 ± 4.7

11.1 ± 3.8

16.8 ± 1.9

5.8 ± 1.1

–

8

86.0 ± 6.2

9.0 ± 2.0

7.6 ± 3.0

17.6 ± 0.6

5.3 ± 3.2

–

40

89.0 ± 14.7

11.6 ± 2.0

7.0 ± 3.4

15.6 ± 4.0

6.6 ± 2.0

–

200

100.6 ± 14.2

5.0 ± 2.0

9.6 ± 2.5

12.0 ± 2.6

4.3 ± 1.1

–

1000

90.0 ± 10.8

10.0 ± 2.6

12.0 ± 5.1

14.0 ± 3.4

5.6 ± 3.0

–

5000

97.0 ± 17.4

7.3 ± 2.0

8.0 ± 2.0

12.6 ± 3.0

5.6 ± 2.8

Positive controls, –S9

Name

NaA

2AA

NaA

2AA

4NOPD

2AA

4NOPD

2AA

9AA

2AA

Concentrations (μg/plate)

2.0

5.0

2.0

2.5

40.0

5.0

40.0

5.0

80

2.5

Mean No. of colonies/plate (average of 3)

318.0 ± 22.2

104.0 ± 6.2

340.3 ± 14.5

10.3 ± 4.0

1009.0 ± 44.3

7.0 ± 1.7

441.6 ± 19.3

20.0 ± 1.7

211.6.± 20.5

7.3 ± 2.0

+

0

96.5± 15.8

10.3 ± 1.9

16.3 ± 3.1

17.1 ± 4.0

7.8 ± 2.4

+

8

94.3 ± 10.0

10.0 ± 2.6

17.0 ± 2.0

17.3 ± 1.1

7.3 ± 1.1

+

40

94.0 ± 4.3

10.6 ± 2.5

17.0 ± 4.5

16.6 ± 1.1

5.3 ± 0.6

+

200

105.0 ± 4.5

8.6 ± 3.0

13.6 ± 1.5

16.6 ± 4.0

7.0 ± 2.0

+

1000

108.6 ± 7.3

12.3 ± 5.0

14.3 ± 4.0

18.6 ± 2.5

6.3 ± 1.5

+

5000

112.0 ± 9.6

10.3 ± 1.1

9.60 ± 1.5

16.3± 7.0

4.6 ± 1.5

Positive controls, + S9

Name

NaA

2AA

NaA

2AA

4NOPD

2AA

4NOPD

2AA

9AA

2AA

Concentrations (μg/plate)

2.0

5.0

2.0

2.5

40.0

5.0

40.0

5.0

80

2.5

Mean No. of colonies/plate (average of 3)

156.6 ± 14.2

884.6 ± 109.5

95.3 ± 6.4

114.3 ± 45.2

1204.6 ± 38.0

569.0 ± 62.0

635.3 ± 27.7

421.3 ± 30.0

88.3 ± 33.2

54.3 ± 16.0

9AA = 9-aminoacridine

2AA = 2-Aminoanthracene

NaA= Sodiumazide

4NOPD= 4-Nitro-o-phenylendiamin

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative