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EC number: 457-890-2 | CAS number: 860399-11-7
- 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:
- 2005-08-23 to 2005-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented study according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- C27H39N3O3
- IUPAC Name:
- C27H39N3O3
- Reference substance name:
- structure formular is shown and is the same as for substance defined in section 1
- IUPAC Name:
- structure formular is shown and is the same as for substance defined in section 1
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PM-6976
- Substance type: light yellow powder
- Physical state: solid
- Analytical purity: 99.3%
- Lot/batch No.: ISJO7-003
- Expiry date: 2006-08-09
- Storage condition of test material: at room temperature in the dark (stability: substance stable under these conditions)
- Soluble in methyl ethyl ketone and acetone
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 192 - 214 g (body weight did not exceed +/- 20% of mean)
- Fasting period before study: max. 20h prior dosing until 3-4 hours after administration of the test substance
- Housing: three animals per cage in labelled Macrolon cages (MIV type; height 18 cm) containing sterilised sawdust as bedding material and paper as cage-enrichment
- Diet: ad libitum standard pelleted laboratory animal diet (from Altromin, Lage, Germany)
- Water: ad libitum tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0 °C
- Humidity (%): 39 - 81 % (only temporary fluctuations above 70% due to cleaning procedures, with no effect on test validity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: selected based on trial formulations performed at the test facility NOTOX and on test substance data supplied by the sponsor
- purchased from Merck, Darmstadt, Germany (specific gravity 1.036)
- preparation: 4 hours prior to dosing; homogeneity accomplished to visually acceptable level - Doses:
- 2000 mg/kg (10 ml/kg) b.w., single dosis on day 1
- No. of animals per sex per dose:
- 3 females per group, two groups of 2000 mg/kg dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality/viability: twice daily
Body weights: days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes, at the end of observation period by oxygen/carbon dioxide procedure - Statistics:
- No statistical analysis was performed for a LD50 estimation.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: up to 2000 mg/kg no mortality occured
- Mortality:
- All rats survived.
- Clinical signs:
- other: Hunched posture in all animals and lethargy in one animal were observed on day 1 after dosing.
- Gross pathology:
- No abnormalities were found.
Any other information on results incl. tables
Table 1: Body weights of all treated rats measured before dosing (day 1) and after dosing (day 8 and day 15)
Animal | day 1 | day 8 | day 15 |
1 (group 1) | 194 | 215 | 233 |
2 (group 1) | 209 | 231 | 254 |
3 (group 1) | 192 | 224 | 241 |
4 (group 2) | 203 | 223 | 233 |
5 (group 2) | 214 | 240 | 247 |
6 (group 2) | 211 | 241 | 249 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS/ CLP
- Conclusions:
- The oral LD50 value of PM-6976 in female Wistar rats was determined to exceed the limit dose of 2000 mg/kg b.w.
- Executive summary:
The acute oral toxicity of the test item PM-6976 was determined by the acute toxic class method according to the OECD guideline 423 (2001) ‘Acute Toxicity-Oral, Acute Toxic Class Method” and GLP using female rats. Two groups of three animals each were treated with the limit single dose of 2000 mg/kg b.w. and observed for 15 days. All rats survived and clinical signs such as hunched posture were only observed on day 1 after dosing. No effects in body weights or abnormalities after macroscopic examination after terminal sacrifice were observed. Hence, the LD5O value of PM-6976 in Wistar rats was found to exceed 2000 mg/kg b.w.. The study is considered valid and reliable without restrictions.
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