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Diss Factsheets
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EC number: 942-466-6 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998-07-07 - 1998-12-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented guideline study in compliance with GLP (conducted with a read-across substance)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- other: viscous liquid
- Details on test material:
- - Molecular formula (if other than submission substance): C28H62NO4P (for a representative structure: Phosphoric acid, di(C8)ester, compds with C12 amine)
- Molecular weight (if other than submission substance): 507.76
- Smiles notation (if other than submission substance): CCCCCCCCCCCCN.O=P(O)(OCCCCCCCC)OCCCCCCCC
- InChl (if other than submission substance): InChI=1/C12H27N/c1-2-3-4-5-6-7-8-9-10-11-12-13/h2-13H2,1H3
- Physical state: liquid
- Storage condition of test material: room temperature in the dark
- Other: Data relating to the identity, purity and stability of the test material are the responsibility of the Sponsor.
Constituent 1
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) Ltd., Margate, Kent, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 204 to 222g (males); 204 to 215g (females)
- Housing: housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet/Water (e.g. ad libitum): free access to mains drinking water and food (except overnight fast before dosing and 3-4 h after dosing); Rat and
Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 50 to 62
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg (Range-finding Study); 2000 mg/kg (Main Study)
- No. of animals per sex per dose:
- 1 male/ 1 female (Range-finding Study)
5 males / 5 females (Main Study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days (Range-finding Study); 14 days (Main Study)
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 5 (Range-finding Study) or 14 days (Main Study).
- Necropsy of survivors performed: yes (Main Study)
-Others: Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes (Range-finding Study). Individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14. - Statistics:
- not applied
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- Hunched posture was noted in all animals during the day of dosing and persisted in all females and one male one day after dosing.
- Body weight:
- All animals showed an expected gain in bodyweight during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Other observations were not performed.
Any other information on results incl. tables
Experimental Preparation
For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in arachis oil BP. Preparation
was aided by the use of a vortex mixer and by heating the formulation in a warming bath at approximately 80 °C. The formulation was allowed to cool
prior to dosing. Determination by analysis of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not specified
in the Study Plan and is not a requirement of the Test Guideline.
Procedure
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was
calculated according to its fasted bodyweight at the time of dosing.
Table 1. Individual Clinical Observations and Mortality Data in the Range-finding Study
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing (Hours) | Effects Noted During Period After Dosing (Days) | |||||||
1/2 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | ||
2000 | 1-0 Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2-0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 = no signs of systemic toxicity
Table 2. Individual Clinical Observations and Mortality Data in the Main Study
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing (Hours) | Effects Noted During Period After Dosing (Days) | ||||||||||||||||
1/2 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 I | 10 | 11 | 12 | 13 | 14 | ||
2000 | 3-0 Male | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3-1 Male | H | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | o | o | 0 | 0 | 0 | i0 | |
3-2 Male | 0 | 0 | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | o | 0 | 0 | 0 | 0 | |
3-3 Male | 0 | 0 | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-4 Male | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-0 Female | H | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | o | |
4-1 Female | 0 | 0 | 0 | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-2 Female | H | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-3 Female | H | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
4-4 Female | H | H | H | H | H | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
H = hunched posture; 0 = no signs of systemic toxicity
Table 3. Individual Bodyweights and weekly Bodyweight Changes in the Main Study
Dose Level mg/kg | Animal Number and Sex | Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 3-0 Male | 216 | 267 | 314 | 51 | 47 |
3-1 Male | 204 | 240 | 274 | 36 | 34 | |
3-2 Male | 222 | 263 | 305 | 41 | 42 | |
3-3 Male | 221 | 282 | 330 | 61 | 48 | |
3-4 Male | 210 | 250 | 297 | 40 | 47 | |
4-0 Female | 215 | 238 | 260 | 23 | 22 | |
4-1 Female | 210 | 233 | 251 | 23 | 18 | |
4-2 Female | 206 | 230 | 252 | 24 | 22 | |
4-3 Female | 204 | 223 | 231 | 19 | 8 | |
4-4 Female | 215 | 228 | 231 | 13 | 3 |
Table 4. Individual Necropsy Findings in the Main Study
Dose Level mg/kg | Animal Number and Sex | Time of Death | Macroscopic Observations |
2000 | 3-0 Male | Killed Day 14 | No abnormalities detected |
3-1 Male | Killed Day 14 | No abnormalities detected | |
3-2 Male | Killed Day 14 | No abnormalities detected | |
3-3 Male | Killed Day 14 | No abnormalities detected | |
3-4 Male | Killed Day 14 | No abnormalities detected | |
4-0 Female | Killed Day 14 | No abnormalities detected | |
4-1 Female | Killed Day 14 | No abnormalities detected | |
4-2 Female | Killed Day 14 | No abnormalities detected | |
4-3 Female | Killed Day 14 | No abnormalities detected | |
4-4 Female | Killed Day 14 | No abnormalities detected |
Evaluation of Data
Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities
including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. According to Regulation (EC) No 1272/2008, the test substance is not classified as acutely toxic by oral route of exposure.
- Executive summary:
A OECD Guideline 401 study was performed to assess the acute oral toxicity of phosphoric acid, mono- and di-(C8 -C10) ester, compds. with C12 -14 amine in the Sprague-Dawley CD strain rat in compliance with GLP. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a solution in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
There were no deaths. Hunched posture was noted in all animals up to one day after dosing. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
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.
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