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EC number: 611-056-6 | CAS number: 538313-26-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June-July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- dated 28 july 2015
method B40bis of the Council regulation No.440/2008 - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']
- EC Number:
- 611-056-6
- Cas Number:
- 538313-26-7
- Molecular formula:
- C2H6CuN10
- IUPAC Name:
- Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Provider : AUTOLIV ASP, 16700 W. Hwy 83, Promontory, UTAH 84307, USA
- batch No. P3656461
- Expiration date of the lot/batch: august 25th 2020
- Purity: 97.4%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in a restricted area dedicated to explosive products, at outside temperature and humidity
- Solubility and stability of the test substance in the solvent/vehicle: not soluble in water
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no treatment
FORM AS APPLIED IN THE TEST (if different from that of starting material)
not different
In vitro test system
- Test system:
- artificial membrane barrier model
- Source species:
- human
- Cell type:
- other: 0.6 cm2 reconstituted epidermis
- Cell source:
- other: epiCS, Cell Systems
- Justification for test system used:
- corrosion assay on animals is forbiden
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): no
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 20 times
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Elx80 absorbance microplate reader Biotek
- Wavelength:570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if viability measured is <50% after 3 min of exposure or if viability measured is >=50% after 3 min and <15% after 60 minutes of exposure
- The test substance is considered to be non-corrosive to skin if viability measured is >= 50% after 3 min and >=15% after 60 minutes of exposure - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied 25 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): PBS PAN BIOTECH GmbH, batch No. 23802016
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 8N KOH, Sigma, batch No. SLBD3295V - Duration of treatment / exposure:
- 3 minutes
30 minutes - Duration of post-treatment incubation (if applicable):
- no applicable
- Number of replicates:
- 2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item: after 3 minutes: 95.11% of viability after 60 minutes: 94.25% of viability
- Value:
- > <
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system:
- Direct-MTT reduction: the intrinsic colour of the test item is blue, wich did not allow to conclude on its direct >MTT reduction potential. 2 killed skin models were added.
- Colour interference with MTT: not interfere with MTT assay
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
- Acceptance criteria met for positive control:
- Acceptance criteria met for variability between replicate measurements:
- Range of historical values if different from the ones specified in the test guideline:
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude taht the test item Copper Dianmmine Bitetrazole (CuDABT) does not have to be classified in category 1 "corrosive". The hasard statement "H314: causes severe skin burns and eye damage" with the signal word "Danger" are not required.
- Executive summary:
The aim of the study was to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (epiCS(R), CellSystems(R)).
The test item Copper Diammine Bitetrazole (CuDABT) was applied as supplied, at the dose of 25 mg, to 2 living and 2 killed Human skin model surfaces (0.6 cm2, epiCS(R), CellSystems(R)) during 3 minutes and 1 hour, followed by a rince with 20 mL of PBS. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with O.E.C.D. test Guideline No. 431 dated 28 July 2015 and the method B.40bis of the Council regulation No.440/2008.
3 minutes and 1 hour after the test item application, the mean corrected percents viability of epidermis skins treated with the test item were 95.11% and 94.25%, versus 5.13% and 0.39%, respectively, with the positive control item (potassium hydroxide 8N).
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item Copper Diammine Bitetrazole (CuDABT) does not have to be classified in Category 1 'Corrosive". The hazard statement "H314: Causes severe skin burns and eye damage" with signal word "Danger" are not required.
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