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EC number: 254-099-2 | CAS number: 38714-47-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 9 December 2016 - 17 November 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: B.40 BIS.: Methods for the determination of toxicity and other health effects: In Vitro Skin Corrosion: Human Skin Model Test; Official Journal of the European Union, No. L 142
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: IATA for skin corrosion and irritation, Series on Testing and Assessment No. 203
- Version / remarks:
- 11 July 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- Tetraamminezinc(2+) carbonate
- EC Number:
- 254-099-2
- EC Name:
- Tetraamminezinc(2+) carbonate
- Cas Number:
- 38714-47-5
- Molecular formula:
- Zn(NH3)4 CO3
- IUPAC Name:
- Tetraamminezinc(2+) carbonate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kampagne 02/2014
- Expiration date of the lot/batch: February 18, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ 200 kit ( EPI-200 tissues with surface of 0.6 cm²), MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue lot number: 23385
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at room temperature or 1 hour in the incubator at 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing: with sterile PBS
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg / mL
- Incubation time: 3 hours
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS
- Viability: 1.404 ± 0.016
- Barrier function: ET-50 = 6.44 hours
(Lower acceptance limit: ET50 = 4.0 hours and Upper acceptance limit: ET50 = 8.7 hours)
- Morphology: functional stratum corneum, a viable basal cell layer, intermediate spinous and granular layers
- Contamination: no, sterile
NUMBER OF REPLICATE TISSUES: 2 per exposure time
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues: EPI-200 tissue that is killed by freezing at –20°C
- N. of replicates : 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA
Step 1: Identification of corrosives:
mean tissue viability
(% of negative control) Prediction
< 45 after 3 min exposure corrosive
>45 after 3 min exposure and < 10% after 1h exposure corrosive
45-55 after 3 min exposure borderline (inconclusive)1
> 55% after 3 min exposure and < 10-20% after 1h exposure borderline (inconclusive) 1
> 55% after 3 min exposure and > 20% after 1 hour exposure non-corrosive
1 The borderlines-evaluation (50 ± 5%, 25 ± 5% and 15 ± 5%) was determined statistically using historic BASF data and hence considers the variance of the test method. This evaluation is an amendment to the evaluation provided in OECD Guideline 431.
Step 2: Optional UN GHS subcategorization of corrosives identified in step 1:
% of negative control) Prediction
< 20 after 3 min exposure UN GSH Cat 1A
20-30% after 3min exposure borderline (inconclusive) for UN GHS subcategorization
> 30% after 3 min exposure UN GHS Cat 1B or 1C
According to the current OECD Guideline 431 differentiation of UN GHS categories 1A versus 1B/C is possible. However, the subcategorization into UN GHS Cat 1A is over-predictive (29% of 1B/C substances are over-predicted as 1A) as stated in the Guideline and differentiation between GHS sub-categories 1B or 1C is not possible. If the test substance is identified to be corrosive by SCT and a transport classification is needed an additional test appropriate for UN GHS subcategorization should be performed to confirm classification as UN GHS Cat 1A or to differentiate between UN GHS Cat 1B and 1C. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL - Duration of treatment / exposure:
- 3 min or 1 hour
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1st run (3 min)
- Value:
- 91.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 12.4%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1st run (1 h)
- Value:
- 20.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 5.6%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2nd run (1 h)
- Value:
- 22.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 6.2%
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: yes
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
Tissue viability is acceptable if the mean OD570 of the NC is ≥ 0.8. The mean OD570 of the NC should not exceed 2.8.
- Acceptance criteria met for positive control: yes
A tissue viability of ≤ 30% is acceptable for the 3-minute exposure. Mean viability of the tissues exposed for 1 hour should be <15%.
- Acceptance criteria met for variability between replicate measurements: yes
In the range of 20% and 100% viability, variability between the tissues is considered to be acceptable if the coefficient of variation (CV) of %-viability is ≤ 30%.
Historic control data:
Historic Range of NC (Period Jan 2015- Jan 2017)
3 min exposure: Mean OD570 1.919 ± 0.177
60 min exposure: Mean OD570 1.936 ± 0.193
Historic Range of PC (Period Jan 2015- Jan 2017)
3 min exposure: Mean OD570 0.282 ± 0.073
60 min exposure: Mean OD570 0.121 ± 0.033
Viability % (Period Jan 2015- Jan 2017)
3 min exposure: Mean % 14.7 ± 3.8
60 min exposure: Mean % 6.2 ± 1.4
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin corrosive (Cat. 1)
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