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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Similar to guideline study and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Remarks:
(GLP was not mandatory at the time of study conduct.)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

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 102
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254
Test concentrations with justification for top dose:
1st series of tests: 4576, 915, 183, 36, 7 µg P3 Oxonia Active/plate (206, 41, 8.2, 1.6 µg peracetic acid/plate)
2nd series of tests: 915, 457, 228, 114, 57 µg P3 Oxonia Active/plate (41, 10, 5.1, 2.6 µg peracetic acid/plate)
Controls
Untreated negative controls:
yes
Remarks:
(distilled water and untreated cell suspensions)
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: (without S9 mix: sodium azide for strains TA 1535 and TA 100; 9-aminoacridin for strain TA 1537; 4-nitro-o-phenylendiamin for strains TA 1538 and TA 98; t-butylhydroperoxide for strain TA 102. With S9 mix: 2-aminoanthracen)
Details on test system and experimental conditions:
- Source of tester strains: American Type Culture Collection, Rockville, Maryland
- Way of application : Test substance was diluted in water. In test tubes, agar, bacterial suspension and test substance solution was added. The agar was supplemented with a histidin/biotin solution (0.5 mM) prior to experiment. Finally, either S9 mix or the according amount of water were added. The suspension was then spread on minimal agar dishes.
- Number of replicates: two independent experiments
- Examinations: Number of bacterial colonies was automatically counted. Each value was measured in triplicate.
- Incubation time: 48 hours

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(at highest concentrations tested)
Additional information on results:
see Tables 1-2 for details
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Reverse mutation assay with P3 oxonia aktiv in bacteria: Mean number of revertants/plate both in the presence and absence of S9 mix - 1st trial

S 9 mix

Test substance concentration
(µg/plate)

Number of revertants (number of colonies/plate)

TA 1535

TA 100

TA 102

TA 1537

TA 1538

TA 98

-

Solvent control

7.8

66.6

175.6

7.0

12.6

17.3

-

7

8.6

65.0

206.0

6.0

12.0

25.0

-

36

9.3

90.3

191.6

6.6

11.3

28.0

-

183

11.6

65.6

231.0

4.0

7.0

9.0

-

915

-a

-a

-a

-a

-a

-a

-

4576

-a

-a

-a

-a

-a

-a

Positive control
no S9 mix

Name

Natriumazid

Natriumazid

t-Butyl-hydro-peroxid

9-Amino-acridin

4-Nitro-o-phenylen-diamin

4-Nitro-o-phenylen-diamin

Concentration (µg/plate)

2

2

100

80

40

40

Number of colonies/plate

213.6

326.0

1338.6

241.3

776.6

598.3

Name

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

Concentration (µg/plate)

5

5

5

5

5

5

Number of colonies/plate

7.3

68.0

178.3

8.6

14.6

20.3

+

Solvent control

13.5

104.3

347.5

12.6

29.6

37.6

+

7

11.3

120.6

406.3

12.6

34.0

43.6

+

36

13.0

128.3

414.0

13.3

26.3

33.0

+

183

14.0

167.6

520.6

12.6

30.0

21.3

+

915

-a

78.6

-a

-a

17.6

26.3

+

4576

-a

-a

-a

-a

-a

-a

Positive control
with S9 mix

Name

Natriumazid

Natriumazid

t-Butyl-hydro-peroxid

9-Amino-acridin

4-Nitro-o-phenylen-diamin

4-Nitro-o-phenylen-diamin

Concentration (µg/plate)

2

2

100

80

40

40

Number of colonies/plate

615.0

610.6

1441.6

408.3

976.3

716.3

Name

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

Concentration (µg/plate)

5

5

5

5

5

5

Number of colonies/plate

91.6

2417.6

1269.0

129.3

2191.3

2194.6

-a: complete bacterial growth inhibition

Table 2: Reverse mutation assay with P3 oxonia aktiv in bacteria: Mean number of revertants/plate both in the presence and absence of S9 mix - 2nd tri

S 9 mix

Test substance concentration
(µg/plate)

Number of revertants (number of colonies/plate)

TA 1535

TA 100

TA 102

TA 1537

TA 1538

TA 98

-

Solvent control

10.0

84.1

208.6

7.1

16.5

22.1

-

57

10.3

132.0

272.0

7.3

15.3

15.3

-

114

8.0

138.6

209.0

6.6

13.3

18.0

-

228

-a

101.0

165.6

5.0

-a

-a

-

457

-a

-a

157.0

-a

-a

-a

-

9156

-a

-a

-a

-a

-a

-a

Positive control
no S9 mix

Name

Natriumazid

Natriumazid

t-Butyl-hydro-peroxid

9-Amino-acridin

4-Nitro-o-phenylen-diamin

4-Nitro-o-phenylen-diamin

Concentration (µg/plate)

2

2

100

80

40

40

Number of colonies/plate

167.3

412.0

750.0

359.6

1009.0

606.0

Name

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

Concentration (µg/plate)

5

5

5

5

5

5

Number of colonies/plate

12.3

100.0

203.6

8.0

17.6

29.0

+

Solvent control

12.0

107.6

452.1

12.1

24.1

49.1

+

57

17.6

135.3

390.0

12.0

25.6

56.6

+

114

11.0

170.6

412.3

12.6

22.0

61.0

+

228

8.3

173.0

462.3

8.3

24.3

41.6

+

457

-a

131.0

466.3

7.0

23.3

-a

+

9156

-a

-a

311.0

-a

-a

-a

Positive control
with S9 mix

Name

Natriumazid

Natriumazid

t-Butyl-hydro-peroxid

9-Amino-acridin

4-Nitro-o-phenylen-diamin

4-Nitro-o-phenylen-diamin

Concentration (µg/plate)

2

2

100

80

40

40

Number of colonies/plate

74.0

440.0

821.6

275.3

823.0

463.0

Name

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

2-Amino-anthrazen

Concentration (µg/plate)

5

5

5

5

5

5

Number of colonies/plate

81.6

1896.0

1040.6

141.3

1493.0

1882.6

-a: complete bacterial growth inhibition

Applicant's summary and conclusion

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

P3 oxonia aktiv (4.6 % peracetic acid, 29.4 % hydrogen peroxide, 7.4 % acetic acid) was tested for its in vitro mutagenicity in an bacterial reverse mutation test (Ames-test). 5 different concentrations of the test material were applied to 6 different strains of Salmonella typhimurium (TA 1535, TA 100, TA 102, TA 1537, TA 1538 and TA 98) in two independent experimental series. The tests were performed on agar plates in the absence or presence of post-mitochondrial supernatant fluids from the liver of male rats treated with Aroclor 1254 (S9-mix).

P3 oxonia aktiv did not induce reverse mutations in the presence or absence of S9-mix in the tested strains of Salmonella typhimurium.