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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:
weight of evidence
Study period:
20 Jun - 29 Jun 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions. No TA102 or E. coli strain included.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no TA102 or E. coli strain included
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
EC Number:
294-574-1
EC Name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
Cas Number:
91744-13-7
IUPAC Name:
91744-13-7
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Chemical denomination: Glyceride, C14-18 and C16-22 unsaturated, mono- and di-
- Batch number: 0189-0-040
- Physical state: clear, yellow-brown liquid
- Analytical purity: approx. 100%
- Receipt of test substance: 1990-03-20

Method

Target gene:
his operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Tween 80/bidist. water
- Justification for choice of solvent/vehicle: The suspension medium was chosen according to the solubility properties tested preliminary before start of the study.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 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 S9: 2-aminoanthracene (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 2 independent experiments

DETERMINATION OF CYTOTOXICITY
- Method: background lawn and/or reduced number of revertants versus negative control

Evaluation criteria:
The results were considered positive if the following criteria were met:
- the plate background of not-reverted bacteria did not show any no growth reduction in comparison to the respective negative controls,
- the spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range,
- the positive controls showed mutation rates exceeding the control values of TA100 at least by the factor 2 and those of the other tester strains at least by the factor 3,
-at more than one dose tested, the test substance caused at least a 2-fold increase in comparison with the negative controls in the tester strain TA100. For the other tester strains, an increase in the mutation rate of more than 3 above the corresponding negative controls was considered positive.
Statistics:
Mean values and standard deviation were calculated.

Results and discussion

Test resultsopen allclose all
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:
cytotoxicity
Remarks:
5000 µg/plate: TA 1535
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
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: Ames Test Results - experiment 1

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 1535

TA 1538

TA 100

TA 98

TA 1537

-

Negative control (water)

8.3

11.0

72.7

28.0

7.7

-

0 (Solvent control)

8.0

11.0

80.3

27.7

6.3

-

8

11.3

11.7

69.7

31.3

8.7

-

40

9.0

11.0

71.7

28.0

6.7

-

200

11.3

8.3

60.0

34.0

5.0

-

1000

8.3

6.7

55.0

24.0

4.7

-

5000

3.7*

6.3

56.7

25.0

4.7

Positive

controls

- S9

Name

SA

4NP

SA

4NP

9AA

Concentrations

(μg/plate)

2

40

2

40

80

Number of colonies/plate

251.0

1262.7

207.0

762.3

581.7

+

Negative control (water)

9.7

14.7

69.3

26.7

6.7

+

0 (Solvent control)

9.0

14.7

79.7

29.0

9.0

+

8

9.7

18.7

75.0

32.3

9.0

+

40

9.7

11.7

79.0

30.7

8.0

+

200

11.7

13.7

68.0

30.0

11.0

+

1000

10.3

16.0

73.3

28.3

7.7

+

5000

3.7*

12.7

53.7

24.3

6.3

Positive

controls

+ S9

Name

2AA

2AA

2AA

2AA

2AA

Concentrations

(μg/plate)

2.5

5

5

5

2.5

Number of colonies/plate

135.7

1403.3

1509.0

1799.7

1654.3

* Partial inhibition of bacterial background lawn

SA = Sodium azide

4NP = 4-Nitro-o-phenylendiamine

9AA = 9-Aminoacridine

2AA = 2-Aminoanthracene

 

Table 2: Ames Test Results - experiment 2

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 1535

TA 1538

TA 100

TA98

TA1537

-

Negative control (water)

10.7

12.3

67.7

28.7

6.3

-

0 (Solvent control)

11.7

13.0

72.3

29.3

6.3

-

8

10.3

14.0

68.7

28.0

5.7

-

40

13.7

8.3

75.7

26.0

7.0

-

200

7.3

8.0

54.7

24.7

4.3

-

1000

7.3

8.0

53.7

26.3

4.0

-

5000

2.7*

8.3

46.3

28.7

1.7

Positive

controls

- S9

Name

SA

4NP

SA

4NP

9AA

Concentrations

(μg/plate)

2

40

2

40

80

Number of colonies/plate

274.0

1410.0

192.0

738.0

646.7

+

Negative control (water)

13.0

19.7

78.7

37.7

10.3

+

0 (Solvent control)

14.3

20.7

82.7

40.0

9.0

+

8

13.7

20.7

76.0

32.7

9.7

+

40

14.7

16.3

85.0

35.7

10.0

+

200

11.7

16.0

75.3

38.7

7.7

+

1000

13.7

18.7

72.0

36.3

6.7

+

5000

7.7*

14.3

61.3

34.7

3.3

Positive

controls

+ S9

Name

2AA

2AA

2AA

2AA

2AA

Concentrations

(μg/plate)

2.5

5

5

5

2.5

Number of colonies/plate

218.3

1413.3

1280.3

1637.0

1993.3

* Partial inhibition of bacterial background lawn

SA = Sodium azide

4NP = 4-Nitro-o-phenylendiamine

9AA = 9-Aminoacridine

2AA = 2-Aminoanthracene

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

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