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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:
experimental study
Adequacy of study:
key study
Study period:
1982- 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Ames, B. N., McCann, J., and Yamasaki, E. (1975). Methods for Detecting Carcinogens and Mutagens with the Salmonella Mammalian-Microsome Test. Mutat. Res. 31, 347-364.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MRC's standard operating procedure for Salmonella typhimurium (Document #B002R3).
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Terphenyl
EC Number:
247-477-3
EC Name:
Terphenyl
Cas Number:
26140-60-3
Molecular formula:
C18H14
IUPAC Name:
1,1':4',1''-terphenyl
Constituent 2
Reference substance name:
MCS-1980
IUPAC Name:
MCS-1980
Details on test material:
- Name of test material (as cited in study report): MCS-1980; CP 2321, 75052; DA-82-240
- Substance type: mixed-terphenyls, -quaterphenyls
- Physical state: solid
- Purity: 100% pur MCS-1980
- Satbility: stable indefinitely
- Lot/batch No.: 82-10-8-581
- Storage condition of test material: test materials were stored in the dark at refrigeration temperature prior to testing.

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:
S-9 mix
Test concentrations with justification for top dose:
0.01, 0.04, 0.2, 1.0, 3.0, 10.0 mg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test material is not soluble in water, partially soluble in ethanol, soluble in DMSO
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
100 µl of solvent per plate
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA1535, TA1537; with metabolic activation
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537; without metabolic activation
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
TA98, TA100; with metabolic activation
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA98, TA100; without metabolic activation
Positive controls:
yes
Positive control substance:
other: sodium nitrite
Remarks:
TA1535; without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: Plates were incubated at 37°C (±1°C) for 48 hours

NUMBER OF REPLICATIONS: Three replicate plates for each strain/microsome/dose level combination

DETERMINATION OF CYTOTOXICITY
- Method: results indicating any effect on the growth of background lawns or any detectable plating interferences
Statistics:
Analysis included Bartlett's test for homogeneity of variance and comparison of treatments with controls uing within-levels pooled variance and a one-sided t-test.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
between 10-0.04 mg
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
negative
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: not soluble in water
- Precipitation: sample precipitates out on plates at 10, 3 and 1 mg/plate

ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the toxicity screen, a concentration of > or = 1mg of sample per plate expressed a slight level of toxicity in the presence and absence of microsomal activation.
Remarks on result:
other: strain/cell type: TA100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The plate incorporation assay: Summary

With microsomal activation

Amount/plate (mg)

Revertants/plate

TA98

TA100

TA1535

TA1537

10.0

42

32

40

138

170

128

10

10

10

9

7

6

3.0

50

35

35

124

154

144

10

7

8

3

6

6

1.0

37

49

43

107

128

124

12

18

14

7

6

5

0.2

46

34

38

128

123

133

16

8

13

10

2

6

0.04

45

47

38

132

126

125

16

9

14

8

7

10

0.01

41

35

33

99

99

81

5

15

8

5

10

4

Controls

Solvent

29

39

38

119

84

81

14

10

12

10

11

11

Negative

45

 

 

75

 

 

6

 

 

8

 

 

Positive

 

861

 

 

1159

 

 

280

 

 

342

 

 

 

Without microsomal activation

Amount/plate (mg)

Revertants/plate

TA98

TA100

TA1535

TA1537

10.0

25

28

28

97

74

73

12

4

12

8

5

4

3.0

27

20

34

77

83

86

5

11

9

5

5

7

1.0

25

29

31

69

60

93

12

7

11

8

6

4

0.2

27

24

30

97

50

58

8

9

6

12

10

5

0.04

27

29

35

78

74

61

11

16

6

12

9

4

0.01

28

30

26

74

77

68

7

5

6

7

6

7

Controls

Solvent

29

27

29

89

63

79

8

8

7

11

19

8

Negative

28

 

 

91

 

 

14

 

 

8

 

 

Positive

 

667

 

 

1174

 

 

535

 

 

1564

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation only for strain TA100

The Ames test indicated that there was no activation without metabolic activation. With metabolic activation, one strain showed positive results (TA100) while all other strains were negative.