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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 20 June 1989 to 12 July 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- 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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A dose ranging study was conducted using 2 males and 2 females at each of 5 dose levels: 1000, 2000, 3000, 4000, 5000 mg/kg.
Based on the results of this, a main study was conducted using 5 males and 5 females at 5000 mg/kg. - GLP compliance:
- yes
- Remarks:
- Authentication confirming that the work was performed in accordance with the principles of Good Laboratory Practice signed by study director 18 January 1990.
- Test type:
- other: not specified
- Limit test:
- no
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,
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Margate, Kent
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 136-222 g
- Fasting period before study: 16-18 h before dosing and 3-4 h post-dosing
- Housing: The rats were housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum of 6 animals per cage for the dose ranging study and 5 animals per cage for the main study.
- Diet (e.g. ad libitum): Expanded Rat and Mouse Maintenance Diet, supplied by Special Diets Servicest 1 Stepfield , Witham, Essex, EMS lAD
- Water (e.g. ad libitum): Tap water was available ad libitum throughout the study
- Acclimation period: At least 7 days before test commencement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean maximum: 22 °C; Mean minimum: 20 °C
- Humidity (%): 50 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light (light hours 0700 - 1900 h)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Dose volume: 10 mL/kg
- Doses:
- In dose ranging study: 1000, 2000, 3000, 4000, 5000 mg/kg
In the main study: 5000 mg/kg - No. of animals per sex per dose:
- In dose ranging study: 2 animals per sex per dose
In the main study: 5 animals per sex per dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observatios. Animals were weighed immediately prior to dosing, 7 days after dosing (main study only) nd at sacrifice at the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
- Preliminary study:
- In the dose ranging study there were no deaths and no clinical signs or gross post mortem observations were noted.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths. Details of test results are given in Table 1.
- Clinical signs:
- other: No clinical signs were noted in any of the animals.
- Gross pathology:
- No abnormalties were detected in the post mortem observations.
Any other information on results incl. tables
Table 1: Test Results, 5000 mg/kg
Animal/sex |
Mortality |
Clinical signs |
Post Mortem Observations |
51-Male |
0/5 |
NAD |
NAD |
52-Male |
NAD |
NAD |
|
53-Male |
NAD |
NAD |
|
54-Male |
NAD |
NAD |
|
55-Male |
NAD |
NAD |
|
56-Female |
0/5 |
NAD |
NAD |
57-Female |
NAD |
NAD |
|
58-Female |
NAD |
NAD |
|
59-Female |
NAD |
NAD |
|
60-Female |
NAD |
NAD |
NAD = No abnormalities detected
Table 2 – Main study: Body weights, 5000mg/kg
Animal number and sex |
Bodyweight (g) |
Weight gain (g) |
||
At Dosing |
After 7 days |
After 14 days |
|
|
51-Male |
215 |
290 |
290 |
75 |
52-Male |
164 |
229 |
228 |
64 |
53-Male |
183 |
225 |
230 |
47 |
54-Male |
190 |
255 |
265 |
75 |
55-Male |
222 |
295 |
296 |
74 |
Mean |
195 |
259 |
262 |
67 |
± S.D. |
24 |
33 |
32 |
12 |
56-Female |
148 |
180 |
200 |
52 |
57-Female |
136 |
170 |
183 |
47 |
58-Female |
140 |
176 |
190 |
50 |
59-Female |
169 |
210 |
226 |
57 |
60-Female |
147 |
187 |
193 |
46 |
Mean |
148 |
185 |
198 |
50 |
± S.D. |
13 |
15 |
17 |
4 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague Dawley was estimated to be >5000 mg/kg bw .
- Executive summary:
The acute oral toxicity potential of a test material, Amgard LR2, was investigated in rats. The vehicle used for the dosing solutions was distilled water. A dose ranging study in pairs of rats indicated that the oral LD50 value is greater than 5000 mg/kg. A main study dose 1eve1 of 5000 mg/kg was selected accordingly. In the main study, no deaths occurred and no clinical signs were noted after oral administration of Amgard LR2 at a dose level of 5000 mg/kg No abnormalities were detected at post mortem. The Median Oral Lethal Dose (LD50) of Amgard LR2 is greater than 5000 mg/kg.
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.
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