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EC number: - | CAS number: -
- 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
In an in vitro membrane barrier test (CORROSITEX™ Assay), conducted according to OECD Test Guideline 435 and to GLP, Pt concentrate P was considered corrosive to the skin and classified as category 1B.
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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 4133/00-K0
- Expiration date of the lot/batch: 07 June 2021
- Purity test date: Certificate of analysis dated 04 December 2020
- Form: liquid
- Appearance: Clear yellow liquid - Test system:
- artificial membrane barrier model
- Justification for test system used:
- Recommended test system in international guideline (OECD 435).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Corrositex® is a test system that is composed of two components, a hydrated collagen matrix (bio-barrier) on a supporting filter membrane and CDS, an underlying aqueous solution of two pH indicator dyes.
The Corrositex® kit contained:
• Bio-barrier matrix.
• Bio-barrier diluent.
• Vials with Chemical Detection System (= CDS).
• Membrane discs.
• Compatibility test tubes.
• Timescale categorize test tubes with buffer A and B.
• Confirm reagent.
The batch number of the kit used for the experiment was CT080320. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL
- Concentration (if solution): as is
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 500 µL
- Concentration (if solution): 10%
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 110 ± 15 mg (≥ 99%). - Duration of treatment / exposure:
- The test system was observed until a reaction was detected
- Number of replicates:
- 4
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Remarks:
- mean penetration time
- Run / experiment:
- mean of 4 replicates
- Value:
- 21.55
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: GSH 1B
- Other effects / acceptance of results:
- The test passed all acceptance criteria:
a) The negative control citric acid (10%) showed a mean penetration time of >60 minutes and was therefore non-corrosive.
b) The positive control sodium hydroxide (as it is) breakthrough time (18.51 minutes) falls within within ± two standard deviations of the positive control historical mean breakthrough time (Appendix 3).
c) The positive control sodium hydroxide (as it is) showed a mean penetration time of
18.51 minutes and was therefore classified as UN packing group II (=GSH 1B).
Overall it was concluded that the test system functioned properly. - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Pt concentrate P is classified as UN packing group II (= GHS 1B) in the Corrositex® assay under the experimental conditions described in this report.
- Conclusions:
- In an in vitro membrane barrier test (CORROSITEX™ Assay), conducted according to OECD Test Guideline 435 and to GLP, Pt concentrate P was considered corrosive to the skin.
- Executive summary:
In a good quality GLP study, conducted according to OECD Test Guideline 435, the potential of Pt concentrate P to induce skin corrosion was assessed in the "in vitro membrane barrier test (CORROSITEX™ Assay)".
The test item was identified to be a timescale 2 test item and showed a mean penetration time of 21.51 minutes.
Pt concentrate P is therefore classified as "corrosive" to the skin (category 1B), according to EU CLP criteria (EC 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant human irritation/corrosion data were identified.
In a good quality GLP study, conducted according to OECD Test Guideline 435, the potential of Pt concentrate P to induce skin corrosion was assessed in the "in vitro membrane barrier test (CORROSITEX™ Assay)". The test item was identified to be a timescale 2 test item and showed a mean penetration time of 21.51 minutes. Pt concentrate P is therefore classified as "corrosive" to the skin (category 1B), according to EU CLP criteria (EC 1272/2008).
No eye or respiratory tract data were identified. However, eye irritation testing is not considered appropriate as Pt concentrate P is classified as corrosive to the skin.
Justification for classification or non-classification
Based on the results of the available reliable in vitro skin corrosion study, Pt concentrate P should be classified as corrosive to the skin (category 1B) according to EU CLP criteria (EC 1272/2008). Substances that are corrosive to the skin are considered as leading to serious damage to the eyes. Consequently, Pt concentrate P should be classified for eye effects in Category 1 according to EU CLP criteria (EC 1272/2008).
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