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Diss Factsheets
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EC number: 224-581-7 | CAS number: 4418-61-5
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.11.2017 – 23.11.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Tetrazol-5-ylamine
- EC Number:
- 224-581-7
- EC Name:
- Tetrazol-5-ylamine
- Cas Number:
- 4418-61-5
- Molecular formula:
- CH3N5
- IUPAC Name:
- tetrazol-5-ylamine
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Not available
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid: crystalline
- Details on test material:
- white crystals
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar Han, monitored quality
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Lysolajské údolí 15/53, Czech Republic, RČH CZ 11760500
- Age at study initiation: 8 weeks
- Weight at study initiation: 178 - 190 g
- Housing: animal room with monitored conditions – 3 animals of one sex in one plastic breeding cage with sterilized shavings of soft wood
- Diet (e.g. ad libitum): pelleted standard diet for experimental animals ad libitum
- Water (e.g. ad libitum): drinking water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C, permanently monitored
- Humidity: 30 – 70 %, permanently monitored
- Photoperiod: 12 hour light/12 hour dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
Aqua pro iniectione - Lot/batch no.: 1703240253 (expiration 03/2019), producer Ardeapharma Ševětín, Czech Republic
DOSING:
The dose level of 300 mg/kg of body weight was used as the starting dose, according to the test guideline, because there was no information about toxicity from sponsor. This dose caused no death of 3 females in group No.1. The dose of 2000 mg/kg level was sequentially applied (application with time distance 24 hours) to 3 females in group No. 2. Because this dose caused no death of females, the same dose of 2000 mg/kg level was sequentially applied for confirmation to 3 females in group No. 3. No death of animals was observed in this group.
PREPARATION AND APPLICATION OF THE TEST SUBSTANCE
Immediately before application the test substance was weighed, mixed in vehicle (aqua pro iniectione) and resulting suspension was administered to the stomach by tube. - Doses:
- 300 mg/kg (1st step)
2000 mg/kg (2nd step)
2000 mg/kg (confirmation) - No. of animals per sex per dose:
- 3 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1st day: twice (30 minutes and 3 hours after application), 2nd day: twice (in the morning and in the afternoon), thereafter days: once a day
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Necropsy of survivors performed: yes
- Other examinations performed: nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death of animals.
- Clinical signs:
- other: No clinical signs of intoxication were observed in all 9 females during the clinical observation after the application.
- Gross pathology:
- No pathologic macroscopic changes were diagnosed during pathological examination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study.
The test item administered at the dose of 300 mg/kg and 2000mg/kg caused no death of animals. No serious clinical signs of intoxication were detected at these doses during whole study. Weight increments were adequate to species, sex and age of animals in experiment.
No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test item, 5-aminotetrazole, for female rats is higher than 2000 mg/kg of body weight. - Executive summary:
The aim of the study was to investigate acute toxic effects of the test item 5-aminotetrazole, after a single oral administration to Wistar Han rats.
The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test item was administered in a single dose as a suspension in vehicle (Aqua pro iniectione), given orally via gavage to female Wistar rats. The volume of administered suspension was 1 ml/100 g body weight of animals.
The dosing was performed sequentially in three groups of three females: Group No. 1- the first step - using the starting dose of 300 mg/kg of body weight, this dose caused no death of animals. Group No. 2 - the second step using higher dose of 2000 mg/kg, this dose caused no death of animals, therefore the dose of 2000 mg/kg was sequentially applied for confirmation to group No. 3 in the third step.
The test item administered at the dose of 2000 mg/kg of body weight caused no death of all 6 females in group No. 2 a No. 3.
No clinical signs of intoxication were detected during the whole study in all 9 animals.
No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results, the value of LD50 of the test item, 5-aminotetrazole, for female rats is higher than 2000 mg/kg of body weight.
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