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Diss Factsheets
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EC number: 939-981-3 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23rd September 2014 - 14th October 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Substance in 80% solution with propylene glycol in order to make the test feasable. The solvent is not thought to affect the results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of triethanolamine esters of polyphosphoric acids with alkyl derivatives of pyridine
- EC Number:
- 939-981-3
- IUPAC Name:
- Reaction products of triethanolamine esters of polyphosphoric acids with alkyl derivatives of pyridine
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- IUPAC Name:
- propylene glycol
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Date Recieved: 29th July 2013
- Expiration date of the lot/batch: Not Supplied
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under storage conditions: Stable
- Stability under test conditions: Stable
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 163-178g
- Fasting period before study: Overnight
- Housing: Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to food was allowed throughout the study.
- Water (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12hours / 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Remarks:
- For the purpose of the 2000 mg/kg dose level the test item was used as supplied.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation.
GLP Statement for exception: No analysis was carried out to determine the homogeneity, concentration or stability of the testitem formulation. The test item was formulated within two hours of it being applied to the testsystem; it is assumed that the formulation was stable for this duration. This exception isconsidered not to affect the purpose or integrity of the study.
Dimethyl sulphoxide was used because the test item did not dissolve/suspend in distilled water or arachis oil BP.
MAXIMUM DOSE VOLUME APPLIED: 2000mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test item, 300 mg/kg was chosen as the starting dose. - Doses:
- 300mg/kg
2000mg/kg - No. of animals per sex per dose:
- 1 female rat at 300mg/kg
1 female rat at 2000mg/kg
4 further female rats at 2000mg/kg
Totalling 5 at 2000mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Weighing was done on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: At the end of the observation period the animals were subjected to gross necropsy. This consisted of an external examination and opening of the
abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- N/A
Results and discussion
- Preliminary study:
- There was no mortality in the rat tested at 300mg/kg or at 2000mg/kg
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths
- Clinical signs:
- other: Hunched posture was noted in all animals. Ataxia was also noted in the four additional treated animals and red/brown staining of the eyes was also noted in two of these animals.
- Gross pathology:
- No abnormalities detected
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose was estimated to be greater than 2000mg/kg body meight. The test item is therefore classed as category 5 (GHS).
- Executive summary:
Introduction
The acute oral median lethal dose was assessed in female wistar rats.
Methods
The test was in line with the following guidelines:
- OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (2001)
- Method Bl bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality - No deaths
Clinical observations - Hunched posture was noted in all animals. Red/brown staining of the eyes and/or ataxia was also noted in the four additional treated animals. Animals appeared normal I or 2 days after dosing.
Body weight - All animals showed expected gains in body weight
Necropsy - no abnormalities were noted at necropsy
Conclusion
The acute oral median lethal dose (LDso) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Category 5).
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