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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
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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)
Controlsopen allclose all
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
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
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
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
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
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 Ferrophosphorus (Fe3P) showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.