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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:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Studies according to recognized guidelines, but not GLP.

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:
not specified
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrocatechol
EC Number:
204-427-5
EC Name:
Pyrocatechol
Cas Number:
120-80-9
Molecular formula:
C6H6O2
IUPAC Name:
pyrocatechol
Details on test material:
No data

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98,TA 100,TA 1535,TA 1537,TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction was from Sprague-Dawley rats pretreated with Aroclor 1254. The S9-Mix contained 100 µl of liver homogenate/ml
Test concentrations with justification for top dose:
3.9 - 15.6 - 62.5 - 250 - 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: no data
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see details below
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

POSITIVE CONTROLS:
- Without S9: MNNG for TA 1535 and TA 100 (1.6 µg), 9-aminoacridine for TA 1537 (50 µg), Daunomycine for TA 98 (5 µg) and 4-nitroquinoline-N-Oxide for TA 1538 0.25 µg).
- With S9: 2-anthramine (12.5 µg).

* Culture preparation: The histidine requirement for growth was checked for each frozen stock culture preparation. The presence or absence of the R-factor plasmid, the presence of the rfa mutation through sensitivity to crystal violet and the uvrB mutation through sensitivity to ultraviolet light were also verified.
* Base medium was prepared with agar Bacto-Difco at 1.5 % in Vogel-Bonner minimal medium E and 2 % of glucose. Overlay agar was made of 0.6 % agar Bacto-Difco in 0.6% NaCl containing L-histidine and biotine.
Evaluation criteria:
A positive response was indicated by a reproductible, dose-related increase, whether it be two-fold over background or not.
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 98,TA 100,TA 1535,TA 1537,TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 1000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

Study 7960 05

 

 

TA 1535

TA 1537

TA 98

µg/plate

+S9

-S9

+S9

-S9

+S9

-S9

0

16

18

18

9

49

25

3.9

27

20

16

8

53

24

15.6

20

25

17

8

53

25

62.5

24

23

13

7

54

31

250

25

25

11

9

54

19

1000

21

11

7

7

54

18

Positive control

315

1720

102

173

2943

209

Ethanol

22

21

15

7

40

19

 

 

TA 100

TA 1538

µg/plate

+S9

-S9

+S9

-S9

0

117

119

20

13

3.9

104

99

21

18

15.6

110

112

24

12

62.5

111

102

19

10

250

118

101

22

9

1000

111

85

22

9

Positive control

1693

2176

2220

222

Ethanol

107

114

22

9

 

 

Study 7961 03

 

 

TA 1535

TA 1537

TA 98

µg/plate

+S9

-S9

+S9

-S9

+S9

-S9

0

16

18

18

9

49

25

3.9

27

29

16

5

55

23

15.6

23

18

12

7

54

23

62.5

26

18

13

6

54

27

250

27

20

12

7

48

26

1000

18

11

13

5

43

28

Positive control

315

1720

102

173

2943

209

Ethanol

22

21

15

7

40

19

 

 

TA 100

TA 1538

µg/plate

+S9

-S9

+S9

-S9

0

117

119

20

13

3.9

109

109

29

11

15.6

114

92

27

12

62.5

103

99

26

10

250

95

108

18

12

1000

82

65

20

13

Positive control

1693

2176

2220

222

Ethanol

107

114

22

9

 

Applicant's summary and conclusion

Conclusions:

Negative with and without metabolic activation

The test item presented no mutagenic activity with and without S9 mix in Salmonella Typhimurium in all strains.
Executive summary:

In a reverse gene mutation assay in bacteria (Battelle, 1983), strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of S. typhimurium were exposed to Catechol at concentrations of 0 to 1000 µg/plate in the presence and absence of rat metabolic activation system (S9 mix).

Catechol was tested up to cytotoxic concentrations. The positive controls induced the appropriate responses in the corresponding strains.

There was no evidence of induced mutant colonies over background.

This study is classified as acceptable. This study satisfies the requirement for in vitro mutagenicity (bacterial reverse gene mutation) data.

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