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EC number: 289-108-9 | CAS number: 86014-62-2
- 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:
- 10 March 2017 to 24 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium mono(2- ethylhexyl)phosphate
- Molecular formula:
- C8H22NO4P
- IUPAC Name:
- Ammonium mono(2- ethylhexyl)phosphate
- Reference substance name:
- Ammonium bis(2-ethylhexyl) phosphate
- EC Number:
- 225-615-3
- EC Name:
- Ammonium bis(2-ethylhexyl) phosphate
- Cas Number:
- 4971-47-5
- Molecular formula:
- C16H38NO4P
- IUPAC Name:
- Ammonium bis(2- ethylhexyl)phosphate
- Reference substance name:
- 2-ethylhexyl diphosphate ammonium salts / esters of 2-ethylhexan-1-ol with diphosphoric acid and their corresponding ammonium salts
- Molecular formula:
- C8H23NO7P2
- IUPAC Name:
- 2-ethylhexyl diphosphate ammonium salts / esters of 2-ethylhexan-1-ol with diphosphoric acid and their corresponding ammonium salts
- Test material form:
- liquid
- Details on test material:
- Storage Conditions: Room temperature.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: All within ±20 % of the mean value
- Fasting period before study: Yes
- Housing: The animals were housed in groups of up to five during the acclimatisation period in suspended, solid floor cages with wire lids. From the day prior to dosing (Day-1), the rats were housed in groups of three in similar cages. Bedding was provided on a weekly basis to each cage by use of clean European soft wood bedding (Datesand Ltd., Manchester, UK). Each batch of bedding was analysed for specific constituents and contaminants. No contaminants were present in bedding at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Diet (e.g. ad libitum): Throughout the study the animals had access to 5LF2 EU Rodent Diet 14%, which was freely available to the animals at all times, except for a period of fasting from the evening of the day prior to dosing (Day-1) until approximately 3 hours after dosing. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer.
- Water (e.g. ad libitum): Mains water was provided ad libitum via cage mounted water bottles. The water was periodically analysed for specific contaminants.
- Acclimation period: The condition of the animals was assessed daily throughout the acclimatisation period of 7 to 10 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 ºC
- Humidity (%): 45-65 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: 14 March 2017 To: 27 April 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 and 30 mg/mL for the 2000 and 300 mg/kg dose groups, respectively.
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Not reported.
- Lot/batch no. (if required): n/a
- Purity: n/a
MAXIMUM DOSE VOLUME APPLIED: Dose volume applied at 10 mL/kg (actual volumes dispensed not reported)
DOSAGE PREPARATION (if unusual): n/a
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Data from the non-salt form of this test article indicated no deaths at dose levels of greater than 2000 mg/kg, therefore the first dose level for this study was 2000 mg/kg. - Doses:
- 2000 and 300 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual body weights were recorded on Day-1 (day before dosing) and on Days 1, 4, 8 and 15. Decedent carcass weights were also recorded prior to necropsy
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight. - Statistics:
- n/a
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Three animals treated at 2000 mg/kg were found dead on Day 2. One other animal treated at this dose level was killed in extremis on this day.
No deaths were noted in animals treated at 300 mg/kg. - Clinical signs:
- other: Mouth rubbing was noted immediately after dosing in three animals treated at 2000 mg/kg. Additional clinical signs noted in the animals that died during the study were piloerection, hunched posture, tremors, ptosis and lethargy. No clinical signs were se
- Gross pathology:
- Abnormalities noted at necropsy of one animal treated at 2000 mg/kg that died during the study were gaseous distension of the stomach, duodenum and jejunum and red mucosal surface of the cardia region of the stomach.
No abnormalities were noted at necropsy of all other animals that died or were killed in extremis during the study or at necropsy of those animals that were killed at the end of the study.
Any other information on results incl. tables
Table 2 Mortality Data
Dose |
Mortality (# dead/total) |
Time range of deaths (day) |
2000 |
4/6 |
2 |
300 |
0/6 |
n/a |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the conditions of this study, the test article was classified as Category 4 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
OECD 423 (2017) - In an acute oral toxicity study (OECD 423), groups of fasted, 8-9 week old, female Crl:WI(Han) rats were given a single oral dose of Reaction mass of Ammonium mono(2-ethylhexyl)phosphate, Ammonium bis(2-ethylhexyl)phosphate and 2-ethylhexyl diphosphate ammonium salts in water) at doses 2000 and 300 mg/kg bw and observed for 14 days.
Oral LD50 Females = >300 - 2000 mg/kg bw.
According to the UN GHS classification, the test item can be classified as Category 4 in respect of its acute oral toxicity.
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