Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

At the time the study was performed, no Guideline was compulsory.The study was performed according to the method as described by Ames, B.N. (1975), Mutation Res.31, 347-364.
This method used is widely comparable to OECD 471/EC B. 13/14

Deviations:

yes

Remarks:

No E. coli strain or, alternatively, S. typhymurium TA 102 strain was tested, however, the type and the nature of the 5 strains tested is considered to be sufficient to detect a mutagenic potential of the test item.

GLP compliance:

no

Remarks:

The study was performed under the control of a quality assurance unit similar to GLP.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

EC Number:

279-013-0

EC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Cas Number:

78948-87-5

Molecular formula:

C16H8MgO10.2H

IUPAC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Details on test material:

Test material: Magnesium-monoperoxyphthalate-hexahydrate, H48 Bleach
- Source and lot/batch No.of test material: 0525
- Further relevant properties: White powder with a faint pungent odour

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

0.8, 4, 20, 100 and 500 µg/plate
Selected based on results from preliminary toxicity test with 5µg to 10 mg.

Controls

Positive controls:

yes

Positive control substance:

9-aminoacridine

benzo(a)pyrene

other: N-methyl-N’-nitro-N-nitrosoguanidine, 2-aminoanthracene, 2-Nitroflurane

Details on test system and experimental conditions:

Way of application: An aliquot (0.1 mL) of each test substance concentration was added to a sterile tube containing molten, histidine-deficient agar and bacterial suspension and maintained at 45°C. 0.5 mL rat liver microsomal preparation (S-9 mix) was added where appropriate. The contents of the tubes were poured onto plates containing solidified minimal medium (20 mL). All plates were prepared in duplicate and incubated at 37°C for 48 hours.
Pre-incubation time: 48 hours
Other modifications: None

Evaluation criteria:

Total revertant colonies on nutrient plates were counted

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test substance was not mutagenic in the in-vitro bacterial reversed mutation assay.