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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.10.2017 – 12.01.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Council Regulation (EC) No.440/2008. Published in O.J. L 142, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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
Method
- Target gene:
- gene for histidine or tryptophan synthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- supernatant of rat liver and a mixture of cofactors
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 μg
Selection of doses/toxicity:
Sponsor declared good solubility of the test substance in water. It was not confirmed – after mixture with water in concentration demanded for testing (5000 µg per 0.1 mL) most of the test substance remained undissolved.
Good solubility was found in dimethyl sulfoxide where the test substance melted in immediately in the same concentration.
For toxicity experiment the highest concentration 5 mg per mL (recommended in OECD TG 471) was diluted to the other 5 concentrations in 3 digit places interval. The concentration row was tested for toxicity in strain TA 100 without metabolic activation
No precipitation was observed in top agar or in Petri dishes.
Thinner bacterial background was observed in the highest concentration. As toxicity in the highest dose is allowed, the concentration of 5000 µg per plate was used as maximum in the first mutagenicity experiments. Further doses were diluted with factor approximately 2-√10.
In the first mutagenicity experiments, the highest concentration was mostly toxic for S. typhimurium TA 98, where revertants could not be counted due to colonies in background. In the other bacterial strains, thinner bacterial background occured in the highest concentration.
In the second mutagenicity experiments concentrations were decreased. The maximum concentration 3000 µg per plate was diluted analogically as in the first experiments because of no signs of mutagenicity were noticed. To increase the sensitivity of the assay volume of S9 was increased from 30 to 50 µL.
Fresh suspensions/solutions of the test substance were prepared before each experiment. Concentrations of the test substance suspension/solution were dosed in the volume of 0.1 mL per plate. In all experiments, tubes with application forms of the test substance as well as tubes with top agar were shaken before any handling. - Vehicle / solvent:
- dimethyl sulfoxide (DMSO), Merck Lot. No. K48069252 644, exp. 10/2018
- Justification for choice of solvent/vehicle: solubility of the substance
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- negative controls - 0.1 mL of DMSO
- Remarks:
- Untreated controls - no solvent
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- (AS)
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- (NPD)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene
- Remarks:
- (2-AF)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- (2-AA)
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N´-nitro-N-nitrosoguanidine
- Remarks:
- (MNNG)
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine hydrochloride monohydrate
- Remarks:
- (9-AAc)
- Details on test system and experimental conditions:
- The bacterial tester strains
Salmonella typhimurium
TA 1535 (CCM 3814, lot. No. 2101200916917),
TA 98 (CCM 3811, lot No. 01022001220053),
TA 100 (CCM 3812, lot No. 0102201220054) and
TA 1537 (CCM 3815, lot No. 2101200916918)
as well as
Escherichia coli WP2 uvrA (CCM 4751, lot No. 2104200512732),
were obtained from Czech Collection of Microorganisms (CCM) of Masaryk University, Brno.
Strains TA 98 and TA 1537 detect frame shift mutations, strains TA 100 and TA 1535 serve to detection of base-pair substitution mutations, and strain E.coli WP2uvrA detects cross-linking mutagens
METHOD OF APPLICATION: in medium; in agar (plate incorporation)
NUMBER OF REPLICATIONS: two series
DETERMINATION OF CYTOTOXICITY
- Method: decrease of number of revertants or diminution of bacterial background - Evaluation criteria:
- The main criterion for evaluation of results was modified two-fold increase rule, which is compatible with the application of statistical methods (see below). After this rule the result is positive, if a reproducible doseresponse effect occurs and/or a doubling of the ratio Rt/Rc is reached.
- Statistics:
- For the evaluation of results, the modified two-fold increase rule was used, which is compatible with the application of statistical methods:
Dunkel V. C.. Chu K.C. (1980): Evaluation of methods for analysis of microbial mutagenicity assays in The Predictive Value of Short-Term Screening Tests in Carcinogenicity Evaluation. Elsevier North-Holland Biomedical Press. 231 - 417
Claxton L. D. et al. (1987): Guide for the Salmonella typhimurium/mammalian microsome tests for bacterial mutagenicity. Mutat. Res. 189. 83 - 91
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity in the highest dose is allowed
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- HISTORICAL CONTROL DATA:
Each experiment included corresponding positive (reference mutagens) and negative controls (untreated control, solvent control). Untreated controls contain no solvent and negative controls contain 0.1 mL of DMSO. All the control numbers were compared with historical ranges of mutant frequencies obtained in our laboratory. The actual numbers were in ranges of the historical numbers.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Sponsor declared good solubility of the test substance in water. It was not confirmed – after mixture with water in concentration demanded for testing (5000 µg per 0.1 mL) most of the test substance remained undissolved. Good solubility was found in dimethyl sulfoxide where the test substance melted in immediately in the same concentration.
For toxicity experiment the highest concentration 5 mg per mL (recommended in OECD TG 471) was diluted to the other 5 concentrations in 3 digit places interval. The concentration row was tested for toxicity in strain TA 100 without metabolic activation
No precipitation was observed in top agar or in Petri dishes.
Thinner bacterial background was observed in the highest concentration. As toxicity in the highest dose is allowed, the concentration of 5000 µg per plate was used as maximum in the first mutagenicity experiments. Further doses were diluted with factor approximately 2-√10.
In preliminary cytotoxicity test in Salmonella typhimurium TA 100 without metabolic activation, toxicity occurred in the highest concentration, which was observed as partial diminution of background.
In the first mutagenicity experiment the test substance in the highest concentration was mostly toxic for S. typhimurium TA 98, where revertants could not be counted due to colonies in background. In the other bacterial strains toxicity was manifested as diminution of bacterial background.
In the second mutagenicity experiment, concentrations were generally decreased. Diminution of bacterial background was observed in some bacterial strain in the highest concentration as well as decreased number of revertants (S. typhimurium TA 1535, TA 1537 and TA 98 without metabolic activation). - Remarks on result:
- other: toxicity was observed as partial diminution of background
Applicant's summary and conclusion
- Conclusions:
- In the arrangement given above, the test substance, 5-aminotetrazole, was non-mutagenic for all the used tester strains without as well as with metabolic activation.
- Executive summary:
The test substance, 5-aminotetrazole, was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The performed test was based on EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was dissolved in dimethylsulfoxide and assayed in doses of 30-5000 μg per plate, which were applied to plates in volume of 0.1 mL.
The first mutagenicity experiments were performed without and with metabolic activation using a supernatant of rat liver (30 μL or 100 μL S9 per plate) and a mixture of cofactors by the plate incorporation test with a dose range of 50 – 5000 μg per plate.
The highest concentration was partially toxic, so lower concentrations (30-3000 μg per plate) were used and volume of S9 was increased to 50 μL per plate.
The concurrent positive controls verified the sensitivity of the assay and the metabolising activity of the liver preparations. Average revertant colony counts for the vehicle controls were within the current historical control range for the laboratory.
Under the above-described experimental design, the test substance, 5-aminotetrazole, was non-mutagenic for all the used tester strains without as well as with metabolic activation.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)