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EC number: 913-888-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 27 April 2001 -17 May 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented, GLP-compliant, according to OECD 471 in Salmonella typhimurium and E. coli.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Ninth Addendum to the OECD Guidelines for the Testing of Chemicals, published by OECD, Paris, February 1998.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (1997).
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diammonium hydrogenorthophosphate
- EC Number:
- 231-987-8
- EC Name:
- Diammonium hydrogenorthophosphate
- Cas Number:
- 7783-28-0
- Molecular formula:
- H9N2O4P
- IUPAC Name:
- diammonium hydrogen phosphate
- Reference substance name:
- 231-887-8
- IUPAC Name:
- 231-887-8
- Details on test material:
- - Name of test material (as cited in study report): Diammonium Phosphate (DAP)
- Substance type: brown discrete particles
- Physical state: solid
- Analytical purity: 100% (provided by sponsor)
- Lot/batch No.: July 8, 2000
- Expiration date of the lot/batch: July 8, 2001
- Stability under test conditions: not indicated
- Storage condition of test material: Room temperature, protected from exposure to light and moisture
Constituent 1
Constituent 2
Method
- Target gene:
- Salmonella tester strain cultures: deep rough mutation (ifa) and the deletion in the uvrB gene.
Cultures of tester strains TA98 and TA100: presence of the pKM101 plasmid R-factor.
All WP2 uvrA cultures: deletion in the uvrA gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: TA98 + TA1537: reverted from histidine dependence to histidine independence by frameshift mutagens. TA1535: reverted by mutagens that cause basepair substitutions. TA100: reverted by mutagens that cause both frameshift and basepair substitution mutations
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: Specificity of the reversion mechanism in E. coli is sensitive to base-pair substitution mutations, rather than frameshift mutations
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9-mix from male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- Initial toxicity-mutation assay: 2.5, 7.5, 25, 75, 200, 600, 1800 and 5000 ug per plate.
Confirmatory mutagenicity assay: 50, 150,500, 1500 and 5000 ug per plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water (CAS# 7732-18-5), obtained from Life Technologies, Inc.
- Justification for choice of solvent/vehicle: Based on compatibility with the target cells and workability of the test article in water.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene: 1.0 and 10 ug/plate
- Remarks:
- All tester stains with S9 activation mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without S9 activation mix
Migrated to IUCLID6: 1.0 ug/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535 without S9 activation mix
Migrated to IUCLID6: 1.0 ug/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without S9 activation mix
Migrated to IUCLID6: 75 ug/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without S9 activation mix
Migrated to IUCLID6: 1000 ug/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in top agar (plate incorporation)
DURATION
- Preincubation period: overnight (To assure that cultures were harvested in late log phase, the length of incubation was controlled and monitored)
- Exposure duration: approximately 48 to 72 hours at 37±2°C
NUMBER OF REPLICATIONS:
Initial Toxicity-Mutation Assay in duplicate
Confirmatory Mutagenicity Assay in triplicate
DETERMINATION OF CYTOTOXICITY
The condition of the bacterial background lawn was evaluated for evidence of test article toxicity by using a dissecting microscope.
OTHER EXAMINATIONS:
- Other: Precipitate was evaluated by visual examination without magnification.
OTHER:
Revertant colonies for a given tester strain and activation condition, except for positive controls, were counted either entirely by automated colony counter or entirely by hand unless the plate exhibited toxicity. Plates with sufficient test article precipitate to interfere with automated colony
counting were counted manually. - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in
mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for tester strains TA98, TA1OO and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two
times the mean vehicle control value. - Statistics:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated.
Since no positive responses were observed, no statistical analysis of the responses was performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation conc: Initial Toxicity Mutation Assay: 1,800 µg/plate
Confirmatory Mutagenicity Assay: 5,000 µg/plate - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Initial Toxicity-Mutation Assay
With (+) or Without (-) S9-mix |
Test substance concentration (µg/plate) |
Number of colonies/platea) |
|||||
Base-pair substitution type |
Frame shift type |
||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||
-S9 mix |
Solvent control |
130 |
18 |
13 |
12 |
7 |
|
2.5 |
101 |
12 |
12 |
10 |
4 |
||
7.5 |
118 |
16 |
14 |
14 |
4 |
||
25 |
103 |
17 |
11 |
19 |
6 |
||
75 |
102 |
16 |
16 |
14 |
5 |
||
200 |
128 |
14 |
11 |
13 |
7 |
||
600 |
91 |
14 |
10 |
16 |
6 |
||
1800 |
100 * |
14 * |
12 * |
12 * |
5 * |
||
5000 |
83 * |
16 * |
10 * |
12 * |
5 * |
||
+S9 mix |
Solvent control |
145 |
21 |
14 |
15 |
9 |
|
2.5 |
119 |
9 |
18 |
16 |
9 |
||
7.5 |
124 |
11 |
14 |
18 |
6 |
||
25 |
117 |
12 |
17 |
19 |
7 |
||
75 |
99 |
11 |
14 |
13 |
6 |
||
200 |
110 |
14 |
13 |
21 |
6 |
||
600 |
92 |
12 |
17 |
15 |
7 |
||
1800 |
90 * |
13 * |
19 * |
17 * |
9 * |
||
5000 |
95 * |
15 * |
9 * |
13 * |
6 * |
||
Positive control without S9 mix |
Name |
NaN3 |
NaN3 |
MMS |
2-NF |
9-AA |
|
Number of colonies/plate |
396 |
176 |
94 |
97 |
343 |
||
Positive control with S9 mix |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
Number of colonies/plate |
486 |
87 |
167 |
459 |
70 |
a) The average number of revertant colonies from two plates
*)Precipitate
NaN3= sodium azide; 2-NF= 2-nitrofluorene; 9-AA = 9-aminoacridine; MMS = methyl methanesulfonate; 2 -AA = 2 -aminoanthracene
Solvent control = water
Confirmatory Mutagenicity Assay
With (+) or Without (-) S9-mix |
Test substance concentration (µg/plate) |
Number of colonies/platea) |
|||||
Base-pair substitution type |
Frame shift type |
||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||
-S9 mix |
Solvent control |
119 |
20 |
16 |
12 |
6 |
|
50 |
101 |
17 |
12 |
12 |
5 |
||
150 |
136 |
17 |
15 |
9 |
5 |
||
500 |
105 |
17 |
15 |
10 |
9 |
||
1500 |
121 |
20 |
13 |
11 |
7 |
||
5000 |
125 * |
19 * |
10 * |
11 * |
5 * |
||
+S9 mix |
Solvent control |
148 |
13 |
19 |
20 |
8 |
|
50 |
144 |
15 |
17 |
17 |
7 |
||
150 |
125 |
15 |
12 |
18 |
8 |
||
500 |
117 |
17 |
13 |
20 |
8 |
||
1500 |
128 |
14 |
16 |
16 |
7 |
||
5000 |
117 * |
15 * |
10 * |
21 * |
5 * |
||
Positive control without S9 mix |
Name |
NaN3 |
NaN3 |
MMS |
2-NF |
9-AA |
|
Number of colonies/plate |
475 |
244 |
100 |
113 |
475 |
||
Positive control with S9 mix |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
Number of colonies/plate |
1094 |
143 |
239 |
977 |
97 |
a) The average number of revertant colonies from three plates
*)Precipitate
NaN3= sodium azide; 2-NF= 2-nitrofluorene; 9-AA = 9-aminoacridine; MMS = methyl methanesulfonate; 2 -AA = 2 -aminoanthracene
Solvent control = water
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
All criteria for a valid study were met as described in the protocol. The results of the Bacterial Reverse Mutation Assay indicate that, under the
conditions of this study, Diammonium Phosphate (DAP) did not cause a positive response in the presence and absence of Aroclor-induced rat liver S9.
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