Perboric acid, sodium salt

Genetic toxicity: in vitro

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

Test material information

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 2

Species / strain / cell type:

S. typhimurium, other: TA2638

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Species / strain 4

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

Controls

Controls 1

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

Controls 2

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.