Diphosphoric acid, zinc salt, compd. with 1,3,5-triazine-2,4,6-triamine (1:1:2)

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD guidelines and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)

EC Number:

690-512-6

Cas Number:

1271172-98-5

Molecular formula:

Zn(C3H7N6)2(P2O7)

IUPAC Name:

Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA97a, TA98, TA100 and TA102

Details on mammalian cell type (if applicable):

- Type and identity of media: Vogel Bonner medium 20 fold
- Properly maintained: yes

Genotype confirmation is performed every quarter.

Strain mutations:
TA97a: hisD6610, urvB, pKM 101, rfa
TA98: hisD3052, urvB, pKM 101, rfa
TA100: hisG46, urvB, pKM 101, rfa
TA102: hisG428, pKM 101, rfa
TA1535L hisG46, urvB, rfa

Metabolic activation:

with and without

Metabolic activation system:

Pre-incubation with S9 mix

Test concentrations with justification for top dose:

First test: 51, 151, 500, 1527 and 4995 ug/plate (plate incorporation method)
Second test: 312, 628, 1254, 2528 and 4999 ug/plate (pre-incubation method)

Vehicle / solvent:

The test substance was suspended in deionised water with all concentrations weighed directly.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO control also used

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

other: 4-Nitro-1,2-phenylene diamine, 2-amino anthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: Plate incorporation method for the first test and pre-incubation method for the repeat test.

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: Per strain and dose, 4 plates with and without S9 mix were used.

Evaluation criteria:

The colonies were counted visually and numbers recorded. A test substance is considered to have mutagenic potential if a significant, reproducible increase of revertant colonies per plate (increase factor of >/= 2) in at least one strain is observed. A concentration related increase over the range tested can also be taken as a sign of mutagenic activity.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not examined

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Confirmation of validity: The treatments conducted for the sterile control and the determination of the titre didn't show any inconsistencies. The determined values for the spontaneous revertants of teh negative controls were in the normal range of the testing laboratory. All positive controls showed positive effects as appropriate.

No signs of toxicity towards the tested strains could be observed.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

The test substance is considered as not mutagenic under the conditions of the test.