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EC number: 614-406-6 | CAS number: 68308-61-2
- 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:
- 2008
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- esterification products of castor oil and polyphosphoric acids
- EC Number:
- 614-406-6
- Cas Number:
- 68308-61-2
- Molecular formula:
- C57H107P3O18
- IUPAC Name:
- esterification products of castor oil and polyphosphoric acids
- Details on test material:
- - Name of test material (as cited in study report): GARDO TP10451
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: 2939R
- Expiration date of the lot/batch: 2010-02-18
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc.
TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, 8 – 9 weeks old
- Weight at study initiation: 183 – 197 g
- Fasting period before study: The day before treatment the animals will be fasted. The food, but not water will be withheld overnight. Animals will be w eighed just before starting the treatment. The food will be given back 3 hours after the treatment.
- Housing: Group caging (3 animals/cage)
- Diet: Animals will receive ssniff SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, and tap water from municipal supply, as for human consumption from 500 ml bottle ad libitum.
- Water: The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 °C
- Humidity (%): 32 - 56 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sunflower oil
- Details on oral exposure:
- VEHICLE
- Vehicle volume admistered: 10 mL/kg bw (was applied as a constant volume; the concentration was adjusted to ensure constant volumes as all dose levels)
- Lot/batch no. (if required): 2007.07.17
MAXIMUM DOSE VOLUME APPLIED:
200 mg/mL
DOSAGE PREPARATION:
Animals will be treated with the test item mixed in the vehicle prepared freshly on the day of treatment.
- Doses:
- 300 mg/kg bw ; 2000 mg/kg bw
- No. of animals per sex per dose:
- 12 female animals (nulliparous, non pregnant); 3 animals/dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed individually 15 and 30 minutes, 1h, 2h, 3h, 4h and 6h after the treatment and once each day 14 d ays thereafter.
- Weight assessment: The body weights were measured and recorded on day 0 (beginning of the experiment), on days 7 and 14 with a precision of 1g
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology - Statistics:
- NA
Results and discussion
- Preliminary study:
- NA
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- GARDO TP10451 did not cause mortality at 300 mg/kg bw and 2000 mg/kg bw dose levels in female rats.
- Clinical signs:
- 300 mg/kg bw – Treatment group 1 and Treatment group 2
No clinical signs were noted for these animals (3/3 Treatment group 1, 3/3 Treatment group 2). The behaviour and general state of animals were considered to be normal on the day of the treatment and during the remaining days of study.
2000 mg/kg bw – Treatment group 3 and Treatment group 4
There were no clinical signs on animals of these groups (3/3 in Treatment group 3 and 3/3 in Treatment group 4) on the day of the treatment and during the following 14-day observation period. - Body weight:
- The body weight development of each animal treated with 300 mg/kg bw (Treatment groups 1 and 2) and 2000 mg/kg bw (Treatment groups 3 and 4) was normal during the two week observation period, similar to untreated female animals of the same age and strain.
- Gross pathology:
- NA
- Other findings:
- NA
Any other information on results incl. tables
Necropsy:
300 mg/kg bw – Treatment group 1 and Treatment group 2
Pinprick-sized haemorrhages (1/3 in group 1 and 2/3 in group 2) and pale raised areas (1/3 in group 2) were observed in the lungs.
2000 mg/kg bw – Treatment group 3 and Treatment group 4
In the lungs, pinprick-sized haemorrhages (2/3 in group 3 and 1/3 in group 4) and pale raised areas (2/3 in group 4) and in the uterus hydrometra (2/3 in group 3) were observed at the terminal necropsy of these animals.
In summary, no test item related macroscopic changes were found at the necropsy. The haemorrhages, and pale raised areas in the lungs, referred to circulatory insufficiency developed during the anaesthesia and exsanguination procedure, which are also observable in untreated animals after anaesthesia. Uterine hydrometra due to the sexual cycle is a common finding in experimental rats.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, a single oral administration of the test item Gardo TP10451 did not cause death of female CRL:(WI)BR rats at 300 mg/kg bw and 2000 mg/kg bw dose levels.
- Executive summary:
Under the conditions of the present study, a single oral administration of the test item Gardo TP10451 did not cause death of female CRL:(WI)BR rats at 300 mg/kg bw and 2000 mg/kg bw dose levels.
According to the Globally Harmonised Classification System, the acute oral LD50 value of Gardo TP10451 was greater than 2000 mg/kg body weight in female CRL:(WI) BR rats and it was ranked into Category 5.
According to directive 2001/59/EC, classification of Gardo TP10451 by the oral route is not required based on the results of this study.
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