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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Comparison on chemically-induced mutation among four bacterial strains, Salmonella typhimurium TA102 and TA2638, and Escherichia coli WP2/pKM101 and WP2 uvrA/pKM101: collaborative study II
Author:
Watanabe K, Sakamoto K & Sasaki T
Year:
1998
Bibliographic source:
Mutat Res 412, 17 - 31

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Principles of method if other than guideline:
Only limited number of strains tested
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
10486-00-7
EC Number:
600-611-8
Cas Number:
10486-00-7
IUPAC Name:
10486-00-7
Details on test material:
-Name of test material (as cited in study report): Sodium perborate tetrahydrate
-Analytical purity: Test item with highest purity available

Method

Target gene:
TA 102 and TA 2638: hisG428
Wp2: trpE56
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 102
Species / strain / cell type:
S. typhimurium, other: TA2638
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
Species / strain / cell type:
E. coli, other: WP2 pKM 101
Metabolic activation:
without
Test concentrations with justification for top dose:
0 - 5000 ug/plate
Vehicle / solvent:
-Vehicle(s)/solvent(s) used: Water and DMSO
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
Migrated to IUCLID6: TA102 and TA2638
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
furylfuramide
Remarks:
Migrated to IUCLID6: WP2/pKM101 and WP2 uvrA/pKM101
Details on test system and experimental conditions:
METHOD OF APPLICATION: plate incorporation

EXPOSURE DURATION: 48 hrs

NUMBER OF REPLICATIONS: at least two independent experiments with 5 dose levels and 3 plates per dose
Evaluation criteria:
Doses with observed cytotoxicity, which was judged by toxicity to the background lawn and/or a reduction in the number of revertant colonies, were excluded from the statistical analysis.
Statistics:
Linear regression test on a 1 % level

Results and discussion

Test results
Species / strain:
other: TA102, TA2638, WP2/pKM101 and WP2 uvrA/pKM101
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
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: Summary of mutagenic activity in four bacterial strains for Sodium Perborate Tetrahydrate

 


Compound

Dose (µg/plate)

Number of revertants (mean)/plate and strain

TA 102
(Salmonella)

TA 2638
(Salmonella)

WP2/pKM101
(E. coli)

WP2uvrA/pKM101 (E. coli)

 

 

Lab. 1

Lab. 2

Lab.1

Lab. 2

Lab. 1

Lab. 2

Lab. 1

Lab. 2

 

 

 

Sodium Perborate

Tetrahydrate

 

 

 

 

 

 

 

 

 

0

322

355

41

36

65

57

62

98

93.5

-

-

-

-

-

64

-

-

156

371

-

43

-

64

-

73

-

187

-

402

-

39

-

63

-

123

313

414

-

67

-

53

-

69

-

375

-

418

-

43

-

83

-

123

625

486

-

99

-

70

-

83

-

750

-

451

-

60

-

89

-

148

1250

561

-

157

-

78

-

168

-

1500

-

511

-

89

-

87b

-

157b

2500

792

-

139

-

113

-

242

-

3000

-

554b

-

109b

-

-

-

193b

5000

750

-

112b

-

233

-

242

-

S9 mix

neg.

 

 

 

 

 

 

 

 

RESULT

 

+

+

+

+

 

b = toxic

- = not tested

+ = positive results in two laboratories

neg. = negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive without metabolic activation

All tested strains showed a positve result in both of the two independant laboratories as documented by a significant increase of revertant colonies. Therefore Sodium Perborate Tetrahydrate is considered to be a mutagen in this bacterial test system
Executive summary:

A collaborative study was carried out using the four bacterial strains TA102, TA2638, WP2/pKM101 and WP2 uvrA/pKM101.

Among other test items, Sodium perborate tetrahydrate was tested using the plate incorporation method. Each test was repeated and performed in two independent laboratories.

The test item showed a positive response in all four tester strains in both the laboratories. Sodium perborate tetrahydrate is therefore considered as mutagen in this test system.