Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 616-036-0 | CAS number: 73963-42-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed in accordance with OECD guideline No.:423.
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole
- EC Number:
- 616-036-0
- Cas Number:
- 73963-42-5
- Molecular formula:
- C11H19ClN4
- IUPAC Name:
- 5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Cilostazol Starting Material 2
- Physical state: white crystalline powder
- Lot/batch No.: PL2488
- Date of analysis: 2009.03.
- Storage condition of test material: In well-closed closed brown vial-up to 25 °C.
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. Cserkesz u. 90. 1103
- Age of animals: Young adult rat, 8 weeks old
-Number of animals: 3 animals/group
- Body weight range at starting (first step): 219-232 g
- Body weight range at starting (second step): 212-225 g
- Acclimation time: 5 days in first step, 6 days in second step
HUSBANDRY
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Light: Artificial light from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/l
- Amount of vehicle (if gavage): 10 ml/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw - Doses:
- 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats.
- No. of animals per sex per dose:
- 2 groups of female rats, 3 rats/group , 1 dose / group.
- Control animals:
- no
- Details on study design:
- - Dosages: Starting dose was selected on the basis of the available information about the test item.
- Procedure: A single oral administration - followed by a 14 days observation period - was performed by gavage. Animals were weighed before the application and the food was given back 3 hours after the treatment.
- Duration of the experimental period: 5 days in first step and 6 days in second step of acclimatization, treatment's day, 14 days post-treatment observation period including the treatment day, necropsy on day 15.
- Body weights were recorded on day 0 (just before the treatment) and at day 7 and at day 15 with precision of 1 g.
- Necropsy: At the and of the observation period all rats were sacrificed under isofluran anaesthesia.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: In group 1 treated with 2000 mg/kg dose clinical sign of reaction comprised of decreased activity (15 cases out of 57 observations), incoordination (10/57), dyspnoea (4/57) and decreased righting reflex (4/57). Decreased activity (score -1, -2, -3) and in
- Gross pathology:
- Severe hydrometria in one animal, and moderate hydrometria in one animal. No pathological changes were found.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute toxic class method (OECD Guideline No. 423) was carried out involving a stepwise procedure with the use of 2000 mg/kg bw dose. The test item is ranked into classes of Globally Harmonized Classification System as GHS category 5 since the LD50 (mg/kg bw) value is above 2000.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.