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EC number: 918-594-3 | CAS number: 7723-14-0
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed and reported non-guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: n.a.
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The solubility and availability for absorption through the gut wall (bioaccessibility) of Red Phosphorus is determined in a model system that simulates the dynamic conditions in the gastro-intestinal tract (TIM-1).
- GLP compliance:
- no
- Remarks:
- not applicable for this study type; the model has been validated for use in the food/nutrition and pharmaceutical area
Test material
- Reference substance name:
- Phosphorus
- EC Number:
- 231-768-7
- EC Name:
- Phosphorus
- Cas Number:
- 7723-14-0
- IUPAC Name:
- phosphine
- Reference substance name:
- phosphorus
- EC Number:
- 918-594-3
- Cas Number:
- 7723-14-0
- Molecular formula:
- (P)n (Phosphorus red modification)
- IUPAC Name:
- phosphorus
- Details on test material:
- - Name of test material (as cited in study report): Red Phosphorus
- Molecular formula (if other than submission substance): Pn (polymeric)
- Molecular weight (if other than submission substance): polymeric
- Physical state: amorphous solid
- Analytical purity: > 99%
- Lot/batch No.: Fra 07-23
- Expiration date of the lot/batch: 24.04.2011
- Storage condition of test material: under nitrogen in an explosion proof cabinet at room temperature
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- other: n.a. in vitro study
- Details on test animals or test system and environmental conditions:
- Please refer to "Details on study design"
Administration / exposure
- Route of administration:
- other: n.a., in vitro study
- Vehicle:
- other: water/artificial saliva
- Details on exposure:
- Please refer to "Details on study design"
- Duration and frequency of treatment / exposure:
- 300 min.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 g Red Phosphorus per run (in artificial saliva and water added to a total of 300g)
- No. of animals per sex per dose / concentration:
- n.a., TIM model used
- Control animals:
- other: n.a.
- Positive control reference chemical:
- n.a.
- Details on study design:
- Test system and gastro intestinal conditions
The experiments were performed in the TIM-1 system (please refer to attached document 1 "scheme of TIM model") simulating the gastric and small-intestineal conditions after intake with only water on an empty stomach by a healthy adult. This presents a worse case scenario for the dissolution of Red Phosphorus, since under these conditions the gastric pH remains low, going from pH 2 to 1.5. The small intestineal pH increases from 6.5 in the first part (Duodenum) to 7.2 in the last part (Ileum). Oral, gastric and duodenal secretion products (electrolytes, digestive enzymes, bile) are secreted to mimic the fasting state. After intake of the meal, gastric juice ( "scheme of TIM model", I) is secreted in the gastric compartment ( "scheme of TIM model", A). The gastric juice contains enzymes and acid to follow the present pH profile, measured with a pH electrode ( "scheme of TIM model", P). After the gastric intake is gradually emptied into the Duodenum ( "scheme of TIM model", C), the chyme is mixed with bile and digestive enzymes ( "scheme of TIM model", J). Bicarbonate is secreted to neutralize the acidic gastric content. After the Duodenum, the chyme is transported through the jejunal and ileal compartments, where digested and dissolved compounds are dialyzed through hollow fiber membranes ( "scheme of TIM model", M). The dialyzed compounds are regarded as available for absorption (bioaccessible) through the gut wall in vivo. The undigested and undissolved compounds are collected in a vessel ( "scheme of TIM model", H). This ileal efflux is regarded as material that enters the large intestine in vivo. During the experiments, the system was flushed with nitrogen. For safety, the Red Phosphorus was handled under a CO2 blanket in an explosion proof fume cabinet and the experiments were performed in a well ventilated room.
Results and discussion
- Preliminary studies:
- None
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- 1.3% bioaccessibility
- Type:
- absorption
- Results:
- no absorption of elemental Phosphorus; only as PO species (Hypophosphite, Phosphite, Phosphate) bioaccessible
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Please refer to "any other information on results incl. tables"
- Details on distribution in tissues:
- n.a.
- Details on excretion:
- n.a.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- No absorption of elemental Phosphorus; only as PO species (Hypophosphite, Phosphite, Phosphate) bioaccessible
Any other information on results incl. tables
Recovery of Phosphorus:
In the first part of the study, all variations (please refer to Administration/Expousre "Any other information") were tested in single experiments. These experiments were performed successfully; however the recovery of Red Phosphorus was 62% and 32% for the test runs with water- and normal secretion, respectively. These low recoveries were result of sticking of the Red Phosphorus to the materials of the system. It was decided to repeat these experiments with a more intensive cleaning step after the experiments. This resulted in recoveries of 83% and 71% for the runs with water- and normal secretion. 32% and 25% of the intake was retained in the gastric compartment, respectively.
Bioaccessiblity of Phosphorus:
The total amounts of Phosphorus in the dialysate and the calculated bioaccessiblities for each run are shown in table 1.
Table 1:Amounts of dialysed total Phosphorus (corresponding to elemental Phosphorus) and bio-accessibilities for each run
|
Variation |
Phosphorus (mg) |
Bioaccessibility (%OI)* |
|
|
|
|
Serie 1 |
Blank |
15.9 |
- |
|
Water secretion |
145.5 |
1.5 |
|
Normal secretion |
98.3 |
0.8 |
|
|
|
|
Serie 2 |
Water secretion |
170.0 |
1.7 |
|
Normal secretion |
185.3 |
1.7 |
|
|
|
|
* of the intake (OI)
The bioaccessibilities for the experiments with water secretion was 1.6 +/- 0.1% of the intake (OI), the mean bioaccessibility of the experiments with normal secretion was 1.3 +/- 0.4% OI.
The amount of total Phosphorus, expressed as a percentage of the intake, that was dialysed in time for both variations is presented in figure 1 of the attached document 3 ("Bioaccessibility of total Phosphorus"). The results show similar pattern for both experiments with water and normal secretion. Approximately 83% of the whole dialysed fraction is dialysed in the first 2 hours, approximately 15% is dialysed between the second and third hour and approximately 2% is dialysed in the last hour.
The calculated amount of total Phosphorus from Phosphorus species analysis (by ion chromatography) for each experiment is presented in table 2.
Table 2:Amounts of dialysed Phosphorus (corresponding to elemental Phosphorus) calculated from the species analysis, for each experiment
|
Variation |
Phosphorus from POspecies (mg)* |
|
|
|
Serie 1 |
Blank |
16.5 |
|
Water secretion |
137.2 |
|
Normal secretion |
103.4 |
|
|
|
Serie 2 |
Water secretion |
178.2 |
|
Normal secretion |
149.3 |
|
|
|
* “PO” refers to Hypophosphite, Phosphite and Phosphate
The results are similar to those obtained with the total Phosphorus analysis as shown in table 1.
The amount of dialysed Phosphorus species in time for the experiments with water- and normal secretion is shown in figures 2 and 3 of the attached document 3, ("Bioaccessibility of total Phosphorus"), respectively. The figures show similar patterns for both experiments with the highest rate of dialysis in the first 120 minutes. This is in agreement with the dialysis patterns for toal Phosphorus. The rations between the amounts of Phosphorus present in each species are shown in figure 4 of the attached document 3,("Bioaccessibility of total Phosphorus"). The results show that with the water secretion experiments, 18 +/- 9%, 48 +/- 3% and 36 +/- 6% of the Phosphorus is present in the PO23 -, PO33 -, PO43 -fractions, respectively. For the experiments with normal secretion this is 7 +/- 4%, 50 +/- 1% and 43 +/- 3%.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The bioaccessibility of Red Phosphorus under the conditions of the TIM model (fasted adult human) was determined to be 1.3 ± 0.4% (exclusively oxidized species; Hypophosphite, Phosphite and Phosphate) of the whole intake. No elemental Phosphorus was present in the bioaccessible fractions. Therefold, it is concluded that elemental Red Phosphorus is not able to pass the dialysis membrane. - Executive summary:
The solubility and availability for absorption through the gut wall (bioaccessibility) of Red Phosphorus is determined in a model system that simulates the dynamic conditions in the gastro-intestinal tract (TIM-1). The bioaccessibility for these conditions was 1.3 ± 0.4% of the applied Red Phosphorus. The majority of Phosphorus is dialysed in the jejunal compartment during the first 120 min. This suggests that the dialysed Phosphorus species were readily available from the Red Phosphorus particles. This was expected, because the particles are always covered with small amounts of Phosphorus Oxy Acids (previously denoted as PO23-, PO33-, PO43 –).
No elemental Phosphorus was present in the bioaccessible fractions. This is in agreement with the likelihood of undissolved elemental Phosphorus able to pass through the dialysis membrane.
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