Phosphorus

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

13 May 2010 - 07 June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to official EC and OECD test guidelines, and in compliance with 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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

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:

triiron phosphide

IUPAC Name:

triiron phosphide

Constituent 2

Reference substance name:

Triiron phosphide

EC Number:

234-682-8

EC Name:

Triiron phosphide

IUPAC Name:

234-682-8

Constituent 3

Reference substance name:

12023-53-9

Cas Number:

12023-53-9

IUPAC Name:

12023-53-9

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Metabolic activation system:

S9 Mix

Test concentrations with justification for top dose:

5, 15, 50, 150, 500, 1500, and 5000 µg/plate.

Vehicle / solvent:

Water containing 0.15% Agar as a suspending agent.
Fe3P was found to be insoluble in water, DMSO, ethanol, acetone, and DMF (common solvents compatible with the test system)

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Migrated to IUCLID6: Used for TA100 and TA1535 in the absence of S9

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: Used for TA1537 in the absence of S9

Controls 3

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

Migrated to IUCLID6: Used for TA98 in the absence of S9

Controls 4

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

Migrated to IUCLID6: Used for WP2 uvrA (pKM101) in the absence of S9

Controls 5

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene, used for TA100, TA1535, and WP2 uvrA (pKM101) in the presence of S9

Controls 6

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

Migrated to IUCLID6: Used for TA98 and TA1537 in the presence of S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72 hours

NUMBER OF REPLICATIONS: Three plates per concentration

DETERMINATION OF CYTOTOXICITY
- Method: appearance of the background bacterial lawn

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The absence of colonies on sterility check plates confirmed the absence of microbial contamination of the S9 mix, buffer and test substance
formulation.

The viability counts confirmed that the viable cell density of the cultures of the individual organisms exceeded 109/mL in all cases, and therefore met the acceptance criteria.

The mean revertant colony counts for the vehicle controls were within or close to the 99% confidence limits of the current historical control range of
the laboratory. Appropriate positive control chemicals (with S9 mix where required) induced substantial increases in revertant colony
numbers with all strains in all reported tests, confirming sensitivity of the cultures and activity of the S9 mix.

First Test
No evidence of toxicity was obtained following exposure to Ferrophosphorus (Fe3P). A maximum exposure concentration of 5000 μg/plate was,
therefore, selected for use in the second test.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to
Ferrophosphorus (Fe3P) at any concentration up to and including 5000 μg/plate in either the presence or absence of S9 mix.

Second Test
No evidence of toxicity was obtained following exposure to Ferrophosphorus (Fe3P). No substantial increases in revertant colony numbers over
control counts were obtained with any of the tester strains following exposure to Ferrophosphorus (Fe3P) at any concentration up to and including
5000 μg/plate in either the presence or absence of S9 mix.

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

It is concluded that Fe3P showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.