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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-04-09 to 2009-04-23
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
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:
- male/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
- Weight at study initiation: Male: 246 - 283 g; Female: 201 – 216 g
- Fasting period before study:
- Cage type: Type II polypropylene/polycarbonate
- Diet: 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
- Water: tap water from the municipal supply
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 – 24°C
- Humidity (%): 35-52 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
-The test item was applied as a single dose uniformly over an area of approximately 10 per cent of the total body surface
REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was removed using water at body temperature
- Time after start of exposure: 24 h
TEST MATERIAL
-The test item was administered in a single dose of 2000 mg/kg bw
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female with a single dose level of 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful individual clinical examination was made on the day of treatment 1 h and 5 h after the administration of the test item, and once each day for 14 days thereafter. The body weight of each animal was recorded on day 0 (beginning of the experiment), on day 7 and on day 14 with a precision of 1 g.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy - Statistics:
- NA
Results and discussion
- Preliminary study:
- NA
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There was no mortality.
- Clinical signs:
- Ther were no clinical signs.
- Body weight:
- The mean body weight and the body weight gain of the male and female animals were considered to be normal during the two-week observation period, similar to the expected values in untreated animals of the same age and strain.
- Gross pathology:
- No macroscopic alterations due to the effects of the test item were found. Gross necropsy revealed pinprick-sized haemorrhages (2/5 male, 1/5 female) and pale raised areas (1/5 male) in the lungs due to the method of anaesthesia and exsanguinations, which are also observable in untreated animals after anaesthesia. Unilateral pyelectasia (1/5 male) as individual alteration is a common finding also found in untreated rats. Hydrometra (2/5) related to the female sexual cycle, is a frequent observation in experimental rats, which had no toxicological significance.
- Other findings:
- NA
Any other information on results incl. tables
no remarks
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- LD50 value of Gardo TP10451 was greater than 2000 mg/kg bw in male and female.
- Executive summary:
Under the conditions of the present study, single 24-hour dermal administration of the test item Gardo TP10451 induced erythema, oedema and scars on the treated skin. Mortalities were not observed, neither in male nor in female CRL:(WI)BR rats. The acute dermal LD50 value of Gardo TP10451 was greater than 2000 mg/kg bw in male and female CRL: (WI) BR rats. According to the current status of the Globally Harmonised Classification System 1), 2) the test item was ranked into Category 5 (or unclassified) and the LD50 was greater than 2000 mg/kg bw, with a cut-off value of 5000 mg/kg bw (or unclassified) in female CRL:(WI) BR rats. Gardo TP10451 does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.
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