Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-059-9 | CAS number: 13597-86-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 12 May 1995 to 13 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
The proposed source chemical (is a mixture of ammonium orthophosphates and ammonium pyrophosphates and is highly soluble in water (> 10000 mg/L). In aqueous media soluble inorganic orthophosphates and pyrophosphates will dissociate to their ionic constituents; in this case ammonium and orthophosphate or pyrophosphate ions. Diammonium dihydrogenpyrophosphate will dissociate to ammonium cations and pyrophosphate anions. The pyrophosphate anions are unstable in aqueous solutions with the degree of instability varying according to pH. In distilled water they will hydrolyse slowly via abiotic mechanisms to orthophosphate. In natural waters a number of different processes can occur; abiotic hydrolysis, biotic degradation (as a result of the action of phosphatases which cleave pyrophosphates into orthophosphate subunits) and assimilation by organisms in the water. Thus, the target substance (diammonium dihydrogenpyrophosphate) and the source substance (mixture of ammonium orthophosphates and pyrophosphates) will be primarily absorbed as the same inorganic ions: ammonium and orthophosphate and are expected to behave in a similar manner under test conditions.
All (bio) transformation products of the source chemical are common to the target chemical and as such the data is considered to be adequate and reliable for use in the assessment of diammonium dihydrogenpyrophosphate for the toxicity hazard assessment.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report attached.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report attached.
4. DATA MATRIX
See read-across justification report attached.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 31 January 1994 Date of signature on certificate: 16 March 1994
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ammonium polyphosphates impurities not otherwise specified
- Molecular formula:
- not applicable
- IUPAC Name:
- Ammonium polyphosphates impurities not otherwise specified
- Test material form:
- liquid
- Details on test material:
- The identity of the test material is not reported within the study report itself, however the data is referred to in the Toxicological Risks of Selected Flame Retardant Chemicals (2000), Subcommittee on Flame-Retardant Chemicals, Committee on Toxicology, Board on Environmental Studies and Toxicology, National Research Council. ISBN: 0-309-59232-1. The substance LR-2 is an ‘ammonium polyphosphate’ and the author provides the following additional information with regards to the chemical identity of LR2: ‘Based on information provided by the manufacturer (Stewart Miller, Albright and Wilson, pers. commun., Nov. 1, 1999), a typical species distribution of polyphosphates in LR2 is 20% orthophosphate, 40% pyrophosphate,
Constituent 1
- Specific details on test material used for the study:
- The identity of the test material is not reported within the study report itself, however the data is referred to in the Toxicological Risks of Selected Flame Retardant Chemicals (2000), Subcommittee on Flame-Retardant Chemicals, Committee on Toxicology, Board on Environmental Studies and Toxicology, National Research Council. ISBN: 0-309-59232-1. The substance LR-2 is an ‘ammonium polyphosphate’ and the author provides the following additional information with regards to the chemical identity of LR2: ‘Based on information provided by the manufacturer (Stewart Miller, Albright and Wilson, pers. commun., Nov. 1, 1999), a typical species distribution of polyphosphates in LR2 is 20% orthophosphate, 40% pyrophosphate,
Method
- Target gene:
- Histidine for Salmonella.
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA100, TA1537, TA1538, TA98
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0, 25, 75, 250, 750, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 4-nitro-o-phenylenediamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: approximately 48 hours
DETERMINATION OF CYTOTOXICITY
- Method: evaluation of number of revertant colonies and examined for a thinning of the background lawn - Evaluation criteria:
- For a substance to be considered positive in this test system, it should have induced a dose-related and statistically significant increase in mutation rate in one or more strains of bacteria in the presence and/or absence of the S9 microsomal enzymes in both experiments at sub-toxic dose levels. If the two experiments give conflicting results or equivocal results are obtained, then a third experiment may be used to confirm the correct response. All data are statistically analysed using the methods recommended by UKEMS (5) and normally Dunnett's method of linear regression is used to evaluate the result. To be considered negative the number of induced revertants compared to spontaneous revertants should be less than twofold at each dose level employed, the intervals of which should be between 2 and 5 fold and extend to the limits imposed by toxicity, solubility or up to the maximum recommended dose of 5000 µg/plate. In this case the limiting factor was the maximum recommended dose.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 100, TA 1535, TA1538, TA98, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Preliminary Toxicity Study
The dose range of the test material used in the preliminary toxicity study was, (after a purity allowance), 0, 25, 75, 250, 750 and 2500 µg/plate. The maximum dose level was not achieved in the preliminary toxicity test, this is not considered significant as there was no toxicity noted in the main experiments at any dose level tested. The test material was non-toxic in the strain of Salmonella used (TA 100).
The mean numbers of revertant colonies for the toxicity assay were:
Strain |
Dose (µg/plate) |
|||||
0 |
25 |
75 |
250 |
750 |
2500 |
|
TA100 |
110 |
107 |
100 |
123 |
117 |
109 |
Mutation Study
The results of the checks for characteristics, viability and spontaneous reversion rate for each tester strain were aU found to be satisfactory.
Results for the negative controls (spontaneous mutation rates) are presented in Table 1.
The individual plate counts, the mean number of revertant colonies and the standard deviations, for the test material, positive and vehicle controls both with and without metabolic activation are presented in Tables 2 and 3 for experiment 1 and Tables 4 and 5 for experiment 2.
Key to Table of Test Results
1 . "Number of revertants" - The observed values and average value (in parentheses) are shown in order, beginning with the lowest concentration of the test substance.
2. Figures immediately below average values refer to standard deviation.
3 . The following postfixes are used when required:
C = contaminated
P = precipitate
S =sparse background lawn
v = very thin background lawn
T = toxic
x = plate unscorable
Table 1: Spontaneous Mutation Rates
Experiment 1:
Number of Revertants (Number of Colonies per plate) |
|||||||||
Base-pair Substitution Type |
Frameshift Type |
||||||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||||
112 |
|
20 |
|
23 |
|
19 |
|
20 |
|
100 |
(98) |
27 |
(23) |
24 |
(22) |
14 |
(17) |
19 |
(17) |
82 |
|
23 |
|
20 |
|
18 |
|
12 |
|
Experiment 2:
Number of Revertants (Number of Colonies per plate) |
|||||||||
Base-pair Substitution Type |
Frameshift Type |
||||||||
TA100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||||
116 |
|
22 |
|
15 |
|
22 |
|
12 |
|
105 |
(102) |
17 |
(19) |
13 |
(22) |
27 |
(17) |
12 |
(10) |
85 |
|
19 |
|
20 |
|
17 |
|
5 |
|
Table 2:
Experiment 1 – Without Metabolic Activation
With or without S9-mix |
Test substance concentration µg/plate |
Number of revertants (Number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA 100 |
TA 1535 |
TA 1538 |
TA 98 |
TA 1537 |
|||||||
- |
0 |
153 |
|
25 |
|
15 |
|
22 |
|
17 |
|
164 |
(149) |
17 |
(22) |
17 |
(18) |
24 |
(21) |
12 |
(12) |
||
131 |
16.8 |
24 |
4.4 |
23 |
4.2 |
18 |
3.1 |
8 |
4.5 |
||
- |
25 |
144 |
|
17 |
|
19 |
|
17 |
|
9 |
|
139 |
(137) |
15 |
(16) |
20 |
(16) |
25 |
(23) |
12 |
(8) |
||
129 |
7.6 |
15 |
1.2 |
10 |
5.5 |
28 |
5.7 |
4 |
4.0 |
||
- |
75 |
136 |
|
13 |
|
23 |
|
23 |
|
14 |
|
122 |
(125) |
18 |
(14) |
19 |
(18) |
19 |
(21) |
12 |
(12) |
||
118 |
9.5 |
12 |
3.2 |
12 |
5.6 |
22 |
2.1 |
9 |
2.5 |
||
- |
250 |
137 |
|
17 |
|
27 |
|
27 |
|
9 |
|
123 |
(127) |
10 |
(15) |
25 |
(19) |
25 |
(23) |
12 |
(9) |
||
121 |
8.7 |
18 |
4.4 |
17 |
1.0 |
17 |
5.3 |
5 |
3.5 |
||
- |
750 |
125 |
|
19 |
|
14 |
|
14 |
|
9 |
|
118 |
(132) |
17 |
(19) |
19 |
(18) |
19 |
(18) |
12 |
(10) |
||
154 |
19.1 |
20 |
1.5 |
20 |
4.0 |
20 |
3.2 |
8 |
2.5 |
||
- |
2500 |
136 |
|
13 |
|
32 |
|
32 |
|
8 |
|
127 |
(128) |
15 |
(14) |
27 |
(19) |
27 |
(26) |
10 |
(10) |
||
120 |
8.0 |
15 |
1.2 |
19 |
4.0 |
19 |
6.6 |
13 |
2.5 |
||
- |
5000 |
90 |
|
10 |
|
19 |
|
19 |
|
8 |
|
85 |
(80) |
10 |
(9) |
15 |
(21) |
15 |
(19) |
3 |
(6) |
||
64 |
14.0 |
8 |
1.2 |
22 |
4.9 |
22 |
3.5 |
8 |
2.9 |
||
Positive controls |
Name |
ENNG |
ENNG |
4NOPD |
4NOD |
9AA |
|||||
Concentration (µg/plate) |
3 |
5 |
5 |
0.2 |
80 |
||||||
S9-mix - |
Number of colonies per plate |
869 |
|
312 |
|
296 |
|
172 |
|
447 |
|
802 |
(794) |
334 |
(308) |
249 |
(267) |
184 |
(182) |
495 |
(444) |
||
712 |
79.8 |
277 |
28.7 |
255 |
25.5 |
189 |
8.7 |
391 |
52.1 |
ENNG = N-ethyl-N’-nitro-N-nitrosguanidine 4NOPD = 4-nitro-o-phenylenediamine
4NQO = 4-nitroquinoline-1-oxide 9AA = 9-aminoacridine
Table 3:
Experiment 1 – With Metabolic Activation
With or without S9-mix |
Test substance concentration µg/plate |
Number of revertants (Number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA 100 |
TA 1535 |
TA 1538 |
TA 98 |
TA 1537 |
|||||||
+ |
0 |
105 |
|
25 |
|
33 |
|
25 |
|
18 |
|
87 |
(98) |
14 |
(16) |
45 |
(32) |
33 |
(31) |
25 |
(24) |
||
103 |
9.9 |
10 |
47.8 |
17 |
14.0 |
34 |
4.9 |
28 |
5.1 |
||
+ |
25 |
106 |
|
17 |
|
33 |
|
41 |
|
23 |
|
97 |
(100) |
10 |
(15) |
30 |
(27) |
34 |
(36) |
20 |
(24) |
||
97 |
5.2 |
19 |
4.7 |
17 |
8.5 |
32 |
4.7 |
28 |
4.0 |
||
+ |
75 |
105 |
|
25 |
|
30 |
|
35 |
|
22 |
|
115 |
(109) |
17 |
(19) |
22 |
(25) |
18 |
(29) |
23 |
(23) |
||
105 |
5.5 |
15 |
5.3 |
19 |
5.7 |
33 |
9.3 |
25 |
1.5 |
||
+ |
250 |
111 |
|
19 |
|
25 |
|
33 |
|
20 |
|
96 |
(103) |
13 |
(15) |
27 |
(26) |
28 |
(28) |
20 |
(21) |
||
101 |
7.6 |
12 |
3.8 |
27 |
1.2 |
22 |
5.5 |
24 |
2.3 |
||
+ |
750 |
96 |
|
13 |
|
32 |
|
19 |
|
14 |
|
111 |
(103) |
24 |
(19) |
24 |
(29) |
32 |
(27) |
18 |
(15) |
||
101 |
7.6 |
19 |
5.5 |
32 |
4.6 |
29 |
6.8 |
14 |
2.3 |
||
+ |
2500 |
107 |
|
14 |
|
27 |
|
19 |
|
17 |
|
116 |
(111) |
10 |
(12) |
36 |
(30) |
34 |
(31) |
23 |
(18) |
||
111 |
4.5 |
12 |
2.0 |
27 |
5.2 |
40 |
10.8 |
15 |
4.2 |
||
+ |
5000 |
105 |
|
12 |
|
29 |
|
28 |
|
12 |
|
102 |
(97) |
8 |
(10) |
32 |
(28) |
20 |
(27) |
12 |
(14) |
||
84 |
11.4 |
9 |
2.1 |
22 |
5.1 |
33 |
6.6 |
17 |
2.9 |
||
Positive controls |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
|||||
Concentration (µg/plate) |
1 |
2 |
0.5 |
0.5 |
2 |
||||||
S9-mix + |
Number of colonies per plate |
732 |
|
110 |
|
294 |
|
276 |
|
219 |
|
803 |
(857) |
139 |
(129) |
191 |
(252) |
220 |
(241) |
232 |
(229) |
||
1035 |
158.5 |
138 |
16.5 |
271 |
54.1 |
227 |
30.5 |
229 |
6.8 |
2AA = 2-aminoanthracene
For Table 4 and 5 - Experiment 2, please see attached document
Applicant's summary and conclusion
- Conclusions:
- The test material was found to be non-mutagenic under the conditions of the test.
- Executive summary:
Salmonella typhimurium strains TA1535, TA1537, TA1538, TA99 and TA100 were treated with the test material using the Ames plate incorporation method at six dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and was, (after a purity allowance of approximately 50%), 25 to 5000 µg/plate in the first experiment. The experiment was repeated on a separate day using the same dose range as experiment 1, fresh cultures of the bacterial strains and fresh chemical formulations. The method used conforms with the OECD Guidelines for the Testing of Chemicals, Protocol No. 471 and also with Method B 14 in Commission Directive 92/69/EEC.
The vehicle (sterile distilled water) control plates produced counts of revertant colonies within the normal range.
All of the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies, both with and without the metabolising system.
The test material caused no visible reduction in the growth of the bacterial lawn at any of the dose levels in any of the strains of Salmonella tested. The test material was therefore, tested up to the maximum recommended dose of 5000 µg/plate.
No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of this test
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.