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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 681-644-5 | CAS number: 136369-04-5
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Details on animal used as source of test system:
- Epi-200 tissues and MTT-100 assays diluent were procured from MatTek Corporation in Ashland, USA. Day of delivery: 17. Dec. 2008 batch: 121108TTA, 120408WDA, 11219
- Vehicle:
- water
- Details on test system:
- Commercially available Epi-200-Kit.
The EpiDermTM tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.Four 6-well-plates were prepared with 0.9 mL assay medium in each well. The inserts containing the tissues were transferred to the wells using sterile forceps and the 6-well-plates were set into the incubator at 37°C and 5% CO2 for one hour (pre-incubation). For each experiment (“three minutes” and “one hour”), one 24-well-plate was prepared as holding plate. 12 wells of each plate were filled with 300 μL assay medium, the other 12 with 300 μL MTT medium. One additional plate was left empty. The plates were stored in the incubator. For each experiment (“three minutes” and “one hour”), two 6-well-plates were used. After pre-incubation, the assay medium was replaced by fresh assay medium and the test was started, using two wells as negative control with 50 μL H2O demin., two wells as positive controls with 50 μL potassium hydroxide solution and two other wells for testing the test item. Solid test items were ground, and 25 mg test item were applied together with 25 μL H2O. At the begin of each experiment (application of negative controls), a stop watch was started. After the respective incubation time, the inserts were removed from the plates using sterile forceps. The inserts were thoroughly rinsed with PBS, blotted with sterile cellulose tissue and set into the respective holding plate, using the wells containing assay medium. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg test item were applied together with 25 μL Water.
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 2
- Vehicle:
- water
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- ca. 87.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- ca. 76.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After treatment with the test item, the relative absorbance values were reduced to 87.8% after three minutes treatment. This value is above the threshold for corrosivity (50%). After one hour treatment, the relative absorbance values were reduced to 76.8%. Lying, above the threshold for corrosivity (15%). Therefore the test item is considered as not corrosive. The negative control was within the normal range (criterion OD > 0.8), showing an OD of
2.134 (3 min.) resp. 2.050 (1 hour). The positive control showed a clear corrosive effect, with value of the three-minuteexperiment being 23.2% and value of the one-hour-experiment being 11.3%. - Executive summary:
One valid experiment was performed. Two tissues of the human skin model EpiDermTM were treated with the test item for three minutes and one hour, respectively. 25 mg of the solid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8m KOH was used as positive control. After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. After treatment with the test item, the relative absorbance values were decreased to 87.8 % after three minutes treatment. This value is well above the threshold for corrosion
potential (50%). After one hour treatment, relative absorbance values were reduced to 76.8 %. This value, too, is well above the threshold for corrosion potential (15%). Therefore, 5-Aminotetrazol Potassium is considered as “not corrosive in the Human Skin Model Test”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The eggs were 10 days in the heating chamber, because the ninth day was a Sunday.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- Freshly laid Lohmann Leghorn chicken eggs were obtained from the LSL Rhein Main Geflügelvermehrungsbetrieb (Dieburg, Germany) ten days before the start of the test. Then the eggs were incubated at 37.0 ± 0.5 °C for ten days (arrived on 23. Jan. 2009). During incubation, the eggs were gently rotated to prevent an attachment of the embryo to one side of the egg.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.2986 g of the test item was given on the membrane in such a manner that 50% of the surface of the membrane were covered with test item.
- Number of animals or in vitro replicates:
- 6 for test item, 3 for controls
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 11.84
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- This in vitro study was performed to assess the irritating potential of 5-Aminotetrazol Potassium by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (ten days old). Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution ) and sodium hydroxide (0.1-n solution) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. A mean irritation score of 19.69 was calculated for the positive control NaOH. This value is considered as valid, because the positive control showed a clear severe irritation. The upper threshold of 19 is not mandatory in the guideline. The negative control showed no irritation, the irritation score for the positive control SDS lay within the demanded range. The test item was tested pure. A mean irritation score of 11.84 was calculated, corresponding to a classification as “severely irritant”. No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
- Executive summary:
One valid experiment was performed. Hen’s eggs with an age of ten days were used. The test item 5-Aminotetrazol Potassium was brought onto the surface of the CAM of a hen’s egg which had been incubated at 37 oC for ten days. Observation time was 5 minutes at room temperature. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the blood vessels under the membrane. Solutions of Sodium Dodecyl Sulfate (1%) and NaOH (0.1 n) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The test item 5-Aminotetrazol Potassium showed severe effects on the blood vessels of the CAM. The calculated mean irritation score is 11.84. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item 5-Aminotetrazol Potassium possesses severe irritation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Eye Irritation/corrosion:
The available study HED-CAM Study is a test methods currently with limited application under REACH (ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a: Endpoint specific guidance, Version 5.0 ,December 2016). Although the test shows positive results and it can be stated that in this study and under the experimental conditions reported, the test item 5-Aminotetrazol Potassium possesses severe irritation potential. Following the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a: Endpoint specific guidance, Version 5.0 ,December 2016 which states that ”The Manual of Decisions of the Competent Authorities (EC, 2009) concluded that there is enough evidence available to conclude that the test methods are able to detect substances causing severe damage to eyes. Positive results can therefore be used for classification purposes i.e. leading to a classification of Category 1 for serious eye damage and labelling with H318 “Causes serious eye damage” according to CLP” it is decided to perform a worst-case classification as Category 1 serious eye damage.
Skin irritation/corrosion:
The available skin corrosion study considered that 5-Aminotetrazol Potassium is “not corrosive in the Human Skin Model Test”. But due to the experimental results in the eye irritation study and the classification as Category 1 serious eye damage, it is decided to perform a worst-case classification as Category 2 skin irritation.
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.