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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-08-2015 until 29-09-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 6 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd mice, Source: Harlan Laboratories S.r.l., Italy
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: 1% aqueous Pluronic PE9200
- Concentration:
- test item concentrations of 50, 25 or 10% (w/v) in 1% Pluronic, corresponding to
46.75 %, 23.375 % or 9.35 % active ingredient, respectively - No. of animals per dose:
- 5
- Details on study design:
- per guideline
- Positive control substance(s):
- other: 25 % (w/v) HCA (dissolved in 1% Pluronic)
Results and discussion
- Positive control results:
- The result of the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in
the same vehicle was used to demonstrate the appropriate performance of the assay [1]. A
significant lymphoproliferative response (stimulation index value of 8.8) was noted for the
positive control chemical, this result confirmed the validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- 50% (w/v)
- Value:
- 1.7
- Test group / Remarks:
- Test group SI values were not significantly different from (vehicle) control (Mann-Whitney U-test versus negative control)
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Remarks:
- 25% (w/v)
- Value:
- 1.1
- Test group / Remarks:
- Test group SI values were not significantly different from (vehicle) control (Mann-Whitney U-test versus negative control)
- Remarks on result:
- other: no indication of skin sensitisation
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Test group SI values were not significantly different from (vehicle) control (Mann-Whitney U-test versus negative control)
- Remarks on result:
- other: no indication of skin sensitisation
- Parameter:
- EC3
- Value:
- 0
- Remarks on result:
- not determinable
- Cellular proliferation data / Observations:
- The appearance of the lymph nodes was normal in all test item treated dose groups except one animal (Animal No.: 9896); this animal had slightly enlarged lymph nodes. Larger than normal lymph nodes were observed in the positive control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present Local Lymph Node Assay the test item (technical product of cyclic phosphonates), tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitiser).
- Executive summary:
To assess the skin sensitising potential of the test item (technical product of cyclic phosphonates)
a Mouse Local Lymph Node Assay has been performed in accordance with GLP requirements.
Groups of five animals each received either the test item formulated in 1% Pluronic at 50, 25, and
10 % (w/v) concentrations or the vehicle (negative control), or 25 % (w/v) HCA (positive control).
No mortality or systemic clinical signs were observed during the study. No treatment
related effects were observed on the mean body weight changes, however marked body
weight loss (>5%) was observed for one animal in the 10 % (w/v) dose group. There were
no indications of any irritancy at the site of application.
The observed stimulation index values were 1.7, 1.1 and 0.9 at concentrations of 50, 25 and
10 % (w/v), respectively.
The result of the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in
the same vehicle was used to demonstrate the appropriate performance of the assay [1]. A
significant lymphoproliferative response (stimulation index value of 8.8) was noted for the
positive control chemical, this result confirmed the validity of the assay.
In conclusion, under the conditions of the present assay the test item,
tested in a suitable vehicle, was shown to have no sensitisation potential (nonsensitiser)
in the Local Lymph Node Assay.
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