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EC number: 478-920-0 | CAS number: 457632-32-5
- 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:
- 10.12.2007- 29.01.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 478-920-0
- EC Name:
- -
- Cas Number:
- 457632-32-5
- Molecular formula:
- C22H44O2.4 C20H38O4.1 (C3H8O3).20
- IUPAC Name:
- 1,20-bis({3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropyl}) icosanedioate
- Test material form:
- solid: pellets
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5-4-A
- Expiration date of the lot/batch: October 2008
- Purity test date: not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, light protected
- Stability under test conditions: unknown in propylene glycol
- Solubility and stability of the test substance in the solvent/vehicle: solubility tested in Non-GLP trial. Dose selection is performed with regard to maximal technically applicable dose.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not stated
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test itrem was weighed into a tared glass beaker on a suitable precision balance and the vehicle was added. Afterwards, the test item in the vehicle was warmed up to 250 °C for approximately 1 min. The formulations were prepared using a magnetic stirrer as homogenizer. The test item preparation was kept at room temperature for cooling and was administered at the temperatures of 24.4 °C and 26 °C.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: 11 weeks
- Weight at study initiation: 162.4 - 194.1 g
- Fasting period before study: 17 - 18 hours
- Housing: in groups of 3
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): community tap water ad libitum
- Acclimation period: 7 or 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10-15 /hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.02g/ml
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: propylene glycol was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 1326803
- Purity: not stated
DOSAGE PREPARATION (if unusual):
The dose formulations were made shortly before each dosing occasion.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle was added (weight:volume). Afterwards, the test item in the vehicle was warmed up to 250°C for approximately 1 minute. The formulations were prepared using a magnetic stirrer as homogenizer. The test item preparation was kept at room temperature for cooling and was administered at the temperatures of 24.4°C and 26°C. The temperature was measured before treatment with a thermometer.
Homogeneity of the test item in the vehicle was maintained during administration using a
magnetic stirer
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: none given - Doses:
- 200 mg/kg bw according to study report.
based on the dosing volume (20 mL/kg) and the concentration of the substance in the vehicle (0.02 g/ml) - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, - Statistics:
- none applied
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths occurred duuring the study.
- Clinical signs:
- other: Approximately 30 m inutes post回dose,a slight to marked poor coordination was observed in all treated females which persisted up to the 5-hour reading. A hunched posture was recorded in four females: in two females within the first 30 minutes up to test da
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The highest technically applicable dose of 200 mg/kg bw did not lead to any mortality in six (6) tested female rats.
- Executive summary:
Two groups, each of three female HanRcc: WIST (SPF) rats, were treated with Nomcort HKP by oral gavage administration at a dosage of 200 mg/kg body weight. The test item was diluted in vehicle (Propylene glycol) at a concentration of 0.02 g/mL and administered at a dosing volume of 20 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
Approximately 30 minutes post-dose, a slight to marked poor coordination was observed in all treated females which persisted up to the 5-hourr eading. A hunched posture was recorded in four females: in two females within the first 30 minutes up to test day 3, in one female approximately 30 minutes up to 5 hours after treatment and additionally on test day 3 and in another female 3-5 hours post-dose. All females were found to be slightly to moderately sedated within the first 30 minutes or 1 hour after treatment up to test day 2. A slightly ruffled fur was noted in all females 1 or 2 hours post-dose and persisted up to test day 2 or 3. Furthermore, one female was found with almost to complete shut eyes at the 3 -hour evaluation.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
The median lethal dose ofNomcort HKP after single oral administration to female rats, observed
over a period of 14 days is:
LD50 (female rat): greater than 200 mg/kg body weight
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