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EC number: 682-385-0 | CAS number: 917805-74-4
- 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:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid
- Cas Number:
- 917805-74-4
- Molecular formula:
- C26H39FN4O6S
- IUPAC Name:
- tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. (Budapest, Cserkesz street 90.)
- Age at study initiation: 8 weeks
- Fasting period before study: overnight
- Housing: 3 animals/ cage Type II polypropylene/polycarbonate
- Bedding: Laboratory bedding
- Diet (e.g. ad libitum): ad libitum, ssniff R/M-Z+H
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days in first step, 8 days in second step, 14 days in third step and 15 days in fourth step
ENVIRONMENTAL CONDITIONS
- Temperature: 22+/-3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12/hour
- Photoperiod (hrs dark/ hrs light): 12 h dark/ 12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: oleum helianthi
- Details on oral exposure:
- VEHICLE
- Conentration in vehicle: 200 and 30 mg/ mL
- Amount of vehicle (if gavarage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/ kg bodyweight
- Doses:
- 2000 mg/kg
300 mg/kg - No. of animals per sex per dose:
- 2*3 females (2000 mg/kg)
2*3 females (300 mg/kg) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter
- Frequency of weighing: just before treatment, on the 7th and 15th day
- Necropsy of survivors performed: yes
- Other examinations performed: individual observations included the status of skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic, central nervous system and somatomotor activity as well
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- All rats dosed at 2000 mg/kg Rosuvastatin TBA Salt (EGIS-14660-3) died between the Day 1 and Day 11. One-one animal died on Day 1 (No.: 3656), Day 4 (No.: 3655), Day 6 (No.: 3641) and Day 11 (No.: 3653) and two animals died on Day 10 (No.: 3643, 3647). All deaths seemed to be consequences of systemic toxic effect of the test item.
No death occurred at 300 mg/kg single oral dose of the test item. - Clinical signs:
- In group 1 treated with 2000 mg/kg dose clinical sign of reaction comprised of decreased activity (3 cases out of 39 observations), abnormal gait (5/39), incoordination (1/39), decreased righting reflex (4/39), decreased grip- and limb tone (3/39), decreased body tone (12/39), closed eyes (1/39), piloerection (9/39), decreased plantary reflex (2/39), decreased abdominal tone (2/39). Decreased activity (score -1, -2, -3), abnormal gait ( score +1, +2), decreased righing reflex (score -1, -2), decreased grip- and limb tone (score -1, -2), decreased body tone (score -1, -2) and piloerection (score +1, +2, +3) occurred in all animals. Decreased plantary reflex (score -1) and decreased abdominal tone (score -1) were found in two animals (No.: 3643, 3647). However, incoordination (score +3) and closed eyes (score +2) were observed in animal No.: 3641.
These symptoms occurred between Day 5 and Day 9. All animals were free symptoms on the treatment day and between Day 1 and Day 4.
In group 2 treated with 2000 mg/kg dose clinical sign of reation comprised of decreased activity (9 cases out of 28 observations), abnormal gait (4/28), incoordination (2/28), decreased body tone (9/28), blood around the eyes (4/28) and piloerection (6/28), Decreased activity (score -1, -2), decreased body tone (score -1, -2) and blood around the eyes (score +2), occurred in two animals (No.: 3653, 3655). However, abnormal gait (score +1, +2), incoordination (score +1) and piloerection (score +1) were observed in animal No.: 3653.
These symptoms occurred between Day 2 and Day 10. All animals were free of symptoms on the treatment day. Besides, animal No.:3655 had no any symptoms on Day 0 and Day 1 and animal No.: 3653 was free of symptoms between Day 0 and Day 2, respectively.
In group 3 and 4 treated with 300 mg/kg dose, the animals were free of symptoms during the study. - Body weight:
- In group 1 (2000 mg/kg) two animals lost body weight between treatment day and Day 7. The loss in body weight was 50 g (24%) in animal No.: 3643 and 43 g (20%) in animal No.: 3647)
In group 2 (2000 mg6kg) one animal lost body weight between treatment day and Day 7. The loss in body weight was 44 g (21 %) in animal No.: 3653.
The body weight loss can be related to the test item toxic effect. The body weight and body weight gain data of the other animals inside the 2000 mg/kg dose group could not be evaluated in consequence of mortalities.
In group 3 and 4 (300 mg/kg), the mean body weight of the animals corresponded to their species and age throughout the study. - Gross pathology:
- All rats treated with 2000 mg /kg dose of the test item spontaneously died during the study. There was no any macroscopic alteration in all died animals treated with 2000 mg/kg dose. All animals treated with 300 mg/kg dose of test item survived until the scheduled necropsy on Day 15. Moderate hydrometra observed in female No.: 3648 of the group 3 (300 mg/kg) is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The method used, is not intended for the precise calculation of a precise LD50 value.
The test item is ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423 as GHS category 4.
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