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Diss Factsheets
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EC number: 915-680-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28-04-2015 - 29-04-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
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:
- September 2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of phosphonic acid, methyl-, bis[(5-ethyl-2-methyl-2,2-dioxido-1,3,2-dioxaphosphorinan-5-yl)methyl] ester with (5-ethyl-2-methyl-2-oxido-1,3,2-dioxaphosphorinan-5-yl)methyl methyl methylphosphonate
- EC Number:
- 915-680-2
- Cas Number:
- 170836-68-7
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- Reaction mass of phosphonic acid, methyl-, bis[(5-ethyl-2-methyl-2,2-dioxido-1,3,2-dioxaphosphorinan-5-yl)methyl] ester with (5-ethyl-2-methyl-2-oxido-1,3,2-dioxaphosphorinan-5-yl)methyl methyl methylphosphonate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Commercial name: AFLAMMIT® PE CONC
Batch number: RP-324566-1512
Chemical Name: Mixture of CAS 42595-45-9 and CAS 41203-81-0 (cyclic phosphonate esters)
In vitro test system
- Test system:
- human skin model
- Remarks:
- SkinEthic™ Reconstructed Human Epidermis
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: no data
- Source strain:
- other: not applicable
- Justification for test system used:
- The SkinEthic™ skin corrosion test method is a validated alternative test procedure to in vivo skin
corrosion effects assessed in rabbits according the OECD guideline 404 and was endorsed by
OECD guideline 431. - Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test materials ( 40 μL liquid) were applied to the RHE tissue (n=2) for 3 minutes and 1 hour at room temperature then rinsed.
- Duration of treatment / exposure:
- 3, 60 minutes
- Duration of post-treatment incubation (if applicable):
- none
- Number of replicates:
- 2 and 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 90.8
- 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:
- Assay Acceptance Criterion 1:
Negative Control viability meets the acceptance criterion.
Assay Acceptance Criterion 2:
Positive Control viability meets the acceptance criterion.
Assay Acceptance Criterion 3: Coefficient of Variation (CV)
The experiments were performed on two tissue replicates per exposure time and difference of
viability between the two tissue replicates not exceed 30% (in the range 20-100% viability, and
for ODs ~ 0.3).
Tiered test for direct MTT reduction
The MTT tiered test ensures that there is not direct interaction between the test sample and MTT
and therefore corrects against chemicals which might otherwise be falsely predicted as noncorrosive.
If interaction is observed, the test substances are applied to freeze killed controlled
tissue to determine the likelihood of the interaction occurring under test conditions.
40 μL of AFLAMMIT® PE CONC was incubated with MTT for 3 hours. There was no visual
evidence of MTT reduction (violet coloration). Therefore application onto freeze killed tissue was
not required.
Batch release quality control
The tissue batch n°15 RHE 054 met the acceptance criteria defined into the certificate of analysis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The viability of the RHE in the presence of the test item (technical product of cyclic phosphonates) was above 50% at 3 minutes
and was above 15% after 1 hour exposure, following analysis by the MTT viability assay.
Therefore, the sample was classified as non corrosive. - Executive summary:
The corrosive potential of the test item (technical product of cyclic phosphonates) was tested using the SkinEthic™ RHE model (OECD 431, GLP) and expressed as a percent of the negative control tissue NC (water).
The viability of the RHE in the presence of the test item was 100% ± 6% (criterium: above 50%) at 3 minutes and was 90.8 ± 6% (critrium: above 15%) after 1 hour exposure, following analysis by the MTT viability assay.
Therefore, the sample was classified as non corrosive.
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