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Diss Factsheets
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EC number: 947-290-3 | CAS number: -
- 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:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, available as unpublished report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
- EC Number:
- 947-290-3
- Cas Number:
- 118286-97-8
- Molecular formula:
- C21H27N5O2 × C4H4O4
- IUPAC Name:
- 8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Buspiron XI. fázistermék
- Physical state: white odourless powder
- Lot/batch No.: 1/1992
- Storage condition of test material: room temperature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species: Rat
- Strain: Wistar
- Sex of animals: female and male rats
- Number of animals: 6 males and 6 females for the treatment group plus 6 males and 6 females in the control group - a total of 24 animals (including control animals)
- Source of test animals: Laboratóriumi Állatokat Tenyésztő és Takarmányellátó Kft. (LATI Kft., 2100 Gödöllő Táncsics Mihály utca 17.)
- Weights of study animals determined at the beginning of the study : 222-264 g (males), 163-185 g (females)
ENVIRONMENTAL CONDITIONS
- Housing conditions: Animals were kept in cages - group-caged by dose
- 6 animals per cage
- Size of boxes: 19.5 x. 43.5 x 29.0 cm
- Bedding: wood shavings
- Temperature in the experimental animal room: 22ºC +/- 3ºC
- Relative humidity: 50-70%
- Lighting: artificial - sequence: 12 hours light, 12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The animals were acclimatised to the laboratory conditions for a week prior to the start of the study.
Before administration of the test chemical, all fur was removed from the dorsal area of the test animals (on approximately 30cm2 of the surface area) by closely clipping.
The animals were treated with the unchanged test material (the test material has not been diluted).
The test chemical was held in contact with the skin with a porous gauze dressing and non-irritating tape (Leukoplast) throughout the 24-hour exposure period - in order to retain the gauze dressing and test chemical and ensure that the animals don't ingest the test chemical.
At the end of the exposure period, residual test chemical was removed, using saline solution (temperature: 37 degrees Celsius). - Duration of exposure:
- Single exposure.
Duration: 24 hours. - Doses:
- Only one dose was tested in the study (limit dose): 10000 mg/kg body weight).
- No. of animals per sex per dose:
- Control groups: 6 males, 6 females.
Treatment groups: 6 males, 6 females. - Control animals:
- yes
- Statistics:
- Body weight - mean and standard deviation values.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- undiluted substance, limit dose test
- Key result
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- undiluted substance, limit dose
- Mortality:
- No deaths have been observed in the course of the 14-day study.
- Clinical signs:
- Following the treatment, animals showed no signs of toxicity.
This was true for both the 6-hour period after the treatment, and the whole 14-day observational period of the study. - Body weight:
- The body weight value of animals measured on Days 7 and Day 14 did not differ from that of the control groups.
This was true for both male and female test animals. - Gross pathology:
- No signs of macroscopic changes were found in post-mortem examinations.
Any other information on results incl. tables
Mortality
Dose (mg/kg body weight) |
Mortality - male rats (number of dead animals/number of animals in the group) |
Moratlity - female rats (number of dead animals/number of animals in the group) |
control |
0/6 | 0/6 |
10000 |
0/6 | 0/6 |
Clinical signs in the 6 hours following the treatment
Dose (mg/kg body weight) |
Clinical signs observed - male rats (number of animals in which the clinical sign have been observed/number of animals in the group) |
Clinical signs observed - female rats (number of animals in which the clinical sign have been observed/number of animals in the group) |
showed no clinical signs of toxicity |
showed no clinical signs of toxicity | |
control | 6/6 | 6/6 |
10000 | 6/6 | 6/6 |
Body weight measurements - male rats
Dose group | Body weight prior to treatment (g) |
Body weight on Day 7 (g) |
Body weight on Day 14 (g) |
|
control | number of data points | 6 | 6 | 6 |
mean | 239.8 | 277.7 | 298.3 | |
standard deviation | 17.3 | 20.5 | 23.1 | |
10000 mg/kg bw | number of data points | 6 | 6 | 6 |
mean | 240.8 | 269.5 | 297.5 | |
standard deviation | 12.3 | 10.6 | 15.7 |
Body weight measurements - female rats
Dose group | Body weight prior to treatment (g) |
Body weight on Day 7 (g) |
Body weight on Day 14 (g) |
|
control | number of data points | 6 | 6 | 6 |
mean | 179.0 | 191.2 | 200.5 | |
standard deviation | 6.1 | 5.7 | 6.4 | |
10000 mg/kg bw | number of data points | 6 | 6 | 6 |
mean | 174.7 | 187.7 | 205.8 | |
standard deviation | 8.4 | 12.5 | 14.5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not classified for Acute Toxicity (dermal exposure route) according to classification criteria laid down in Regulation EC No 1272/2008.
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