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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- 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:
- 1 992
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- no
- Principles of method if other than guideline:
- Similar to OECD TG 423 (Acute Oral Toxicity – Acute Toxic Class Method)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
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 per dose group plus 6 males and 6 females in the control group - a total of 72 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 : 121-177 g (males), 126-162 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. 45.5 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
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- concentration of methylcellulose solution: 1%
- Details on oral exposure:
- VEHICLE
- Substance formulation: test substance suspended in methylcellulose solution (cc: 1%)
- Physical form of the material administered: liquid
- Dosing volumes: 5 mL/kg (for all dose levels and for the control groups)
- Test solutions were administered to the test animals within 1 hour of their preparation
FEED AND DRINKING WATER
- Feed: conventional laboratory diet (standard rodent feed)
- Animals were fasted prior to dosing (food withheld for 12 hours)
- During the period of observations (the 2 weeks following the treatment) animals had feed and water ad libitum
- Microbiological status of the feed and drinking water were checked and found to be adequate
ADMINISTRATION OF THE TEST SUBSTANCE
- Single dose exposure
- Treatment: Day 0
- Observations: Day 1-14
- Necropsy: Day 15 - Doses:
- MALE RATS
0 mg/kg body weight (control)
600 mg/kg body weight
720 mg/kg body weight
860 mg/kg body weight
1040 mg/kg body weight
1250 mg/kg body weight
FEMALE RATS
0 mg/kg body weight (control)
500 mg/kg body weight
600 mg/kg body weight
720 mg/kg body weight
860 mg/kg body weight
1040 mg/kg body weight - No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Statistics:
- LD50 calculation - probit analysis.
Body weight - mean and standard deviation values.
Difference between dose groups - Student's t test.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Remarks:
- oral, 14 days
- Effect level:
- ca. 814.82 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 728.82 - <= 910.96
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- oral, 14 days
- Effect level:
- ca. 822.36 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- >= 710.25 - <= 952.15
- Mortality:
- Lethal dose values:
males: LD50 (rat; 14ays) = 814.8 (728.8-911.0) mg/kg bw
females: LD50 (rat; 14 days) = 822.4 (710.3-952.2) mg/kg bw
Deaths occured within the first 6 hours (following the treatment/exposure). No deaths were observed in the 14-day period (observations) following the treatment.
Cause of death: respiratory arrest. - Clinical signs:
- Following the treatment, animals showed:
- reduced movement
- ataxia
- clonic-tonic muscle spasm
- dyspnea
Animals surviving for 24 hours following the treatment showed signs of recovery and showed no clinical signs in the observational period. - Body weight:
- The body weight value of animals measured on Days 7 and 14 did not differ from that of the control group's.
This was true for both male and female test animals and for every dose group. - Gross pathology:
- No signs of macroscopic changes were found in post-mortem examinations.
This was true for both the animals that have died as a result of the treatment and the surviving animals euthanized after the observational period.
Any other information on results incl. tables
Mortality
dose (mg/kg bodyweight) |
mortality of males (number of dead animals/number of animals in the treatment group) |
mortality of females (number of dead animals/number of animals in the treatment group) |
control | 0/6 | 0/6 |
500 | no data | 0/6 |
600 | 0/6 | 1/6 |
720 | 2/6 | 2/6 |
860 | 4/6 | 3/6 |
1040 | 5/5 | 5/5 |
1250 | 6/6 | no data |
Clinical signs of toxicity observed in the 6-hour period following the administration
Dose (mg/kg bw) | male rats (number of animals in which the clinical sign was detected/number of animals in the dose group) |
female rats (number of animals in which the clinical sign was detected/number of animals in the dose group) | ||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | |
control | 6/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 6/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
500 | - | - | - | - | - | - | 0/6 | 6/6 | 0/6 | 0/6 | 0/6 | 0/6 |
600 | 0/6 | 6/6 | 6/6 | 1/6 | 0/6 | 0/6 | 0/6 | 6/6 | 0/6 | 1/6 | 1/6 | 0/6 |
720 | 0/6 | 6/6 | 6/6 | 2/6 | 2/6 | 0/6 | 0/6 | 6/6 | 0/6 | 0/6 | 2/6 | 3/6 |
860 | 0/6 | 6/6 | 6/6 | 6/6 | 2/6 | 0/6 | 0/6 | 6/6 | 0/6 | 1/6 | 3/6 | 2/6 |
1040 | 0/6 | 6/6 | 6/6 | 6/6 | 0/6 | 4/6 | 0/6 | 5/6 | 0/6 | 3/6 | 3/6 | 2/6 |
1250 | 0/6 | 6/6 | 6/6 | 4/6 | 0/6 | 6/6 | - | - | - | - | - | - |
meaning of clinical signs:
1: test animal shows no signs of toxicity
2: reduced movement
3: ataxia
4: clonic muscle spasm
5: clonic-tonic muscle spasm
6: dyspnea
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 | 145.2 | 199.5 | 222.8 | |
standard deviation | 12.5 | 29.9 | 28.1 | |
600 mg/kg bw | number of data points | 6 | 6 | 6 |
mean | 143.8 | 206.2 | 234.5 | |
standard deviation | 10.7 | 13.3 | 31.9 | |
720 mg/kg bw | number of data points | 6 | 4 | 4 |
mean | 143.5 | 189.5 | 218.5 | |
standard deviation | 13.9 | 14.4 | 22.5 | |
860 mg/kg bw | number of data points | 6 | 2 | 2 |
mean | 146.5 | 228.5 | 273.0 | |
standard deviation | 18.9 | 17.7 | 32.5 | |
1040 mg/kg bw | number of data points | 6 | 1 | 1 |
mean | 144.3 | 162.0 | 250.0 | |
standard deviation | 16.8 | no calculation (number of data points lower than 3) |
no calculation (number of data points lower than 3) |
|
1250 mg/kg bw | number of data points | 6 | - | - |
mean | 145.2 | - | - | |
standard deviation | 12.7 | - | - |
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 | 141.3 | 162.5 | 179.0 | |
standard deviation | 10.1 | 11.2 | 12.6 | |
500 mg/kg bw | number of data points | 6 | 6 | 6 |
mean | 143.3 | 160.8 | 177.2 | |
standard deviation | 11.4 | 11.1 | 12.8 | |
600 mg/kg bw | number of data points | 6 | 5 | 5 |
mean | 140.2 | 159.4 | 176.6 | |
standard deviation | 9.0 | 7.4 | 10.8 | |
720 mg/kg bw | number of data points | 6 | 4 | 4 |
mean | 142.2 | 161.0 | 174.0 | |
standard deviation | 10.0 | 10.8 | 13.8 | |
860 mg/kg bw | number of data points | 6 | 3 | 3 |
mean | 140.7 | 143.0 | 166.3 | |
standard deviation | 8.8 | 29.8 | 22.1 | |
1040 mg/kg bw | number of data points | 6 | 1 | 1 |
mean | 141.2 | 144.0 | 151.0 | |
standard deviation | 9.4 | no calculation (number of data points lower than 3) |
no calculation (number of data points lower than 3) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The substance is harmful if swallowed (Acute Toxicity, Category 4) according to classification criteria laid down in Regulation EC No 1272/2008.
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