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Diss Factsheets
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EC number: 931-597-4 | 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
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Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between 19 May 2010 and 30 July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- The product from the burning of a combination of carbonaceous materials.
- EC Number:
- 931-597-4
- Molecular formula:
- UVCB substance, not available. View remarks field.
- IUPAC Name:
- The product from the burning of a combination of carbonaceous materials.
- Details on test material:
- - Name of test material: Mixed ash
- Physical state: powder
- Composition range of test material (% (w/w)): Aluminium (Al) 13.07, Calcium (Ca) 45.52 , Iron (Fe) 4.15 , Magnesium (Mg) 3.49, Phosphorus (P) 0.79 , Potassium (K) 2.56, Silicon (Si) 28.07, Sodium (Na) 1.08, Sulphur (S) 1.27.
- The critical minor components examined (mg/kg d.w.): Arsenic (As) 18, Barium (Ba) 670 Cadmium (Cd) 3.6, Copper (Cu) 410, Lead (Pb) 180 and Antimony (Sb) 22.
- Purity test date: the substance is UVCB substance
- Lot/batch No.: MIXED ASH 1-01032010
- Expiration date of the lot/batch: March 2011
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature under argon.
- Other: Mixed Ash is named in dossier as Ash. Mixed in the substance name has meant that there has been several (mixed) fuels when producing ash.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, France.
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: males 151.4 g and 181.1 g, females 131.9 g and 151.6 g
- Fasting period before study: -
- Housing: 5 rats of one sex per cage
- Individual metabolism cages: no
- Diet (e.g. ad libitum): RM1 (E)-SQC SDS/DIETEX feed
- Water (e.g. ad libitum): available ad libitum in polycarbonate bottles with a stainless steel nipple
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): relative humidity between 45% and 65%
- Air changes (per hr): approximately 10 times
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness with light on at 7.30 a.m.
IN-LIFE DATES: From: May 19, 2010 To: Jul. 30, 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Ash was weighed in a brown glass flask previously tarred. The vehicle was added. The suspension was ground using a homogeniser without agitation until homogenisation was completed. Samples were taken under magnetic stirring. The test item formulations were prepared daily before administration.
VEHICLE
- Justification for use and choice of vehicle (if other than water): homogeneity of dosing suspensions
- Concentration in vehicle: 0, 50, 100 or 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): SIGMA-Aldrich, Batch No. 044K0101, Expiry date: Oct 2010
HOMOGENEITY AND STABILITY OF TEST MATERIAL: based on chemical analysis of Pb, Cr and Cd; dosing suspension prepared daily immediately before dosing - Duration and frequency of treatment / exposure:
- Once daily for 28 days.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 1000 or 2000 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- 2
- Control animals:
- other: 1% carboxymethyl cellulose
- Positive control reference chemical:
- -
- Details on study design:
- - Dose selection rationale: A dose range-finding study.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled : blood
- Time and frequency of sampling: Day 1: predose, 1 h and 6 h; Day 14: predose; Day 28: predose, 1 h and 6 h.
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify): urine, faeces, tissues, cage washes, bile
Results and discussion
Main ADME results
- Type:
- absorption
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Blood Pb concentrations showed dose-dependent increases and modest accumulation during the Study. Cr concentrations showed at most only very slight increases and virtually no accumulation. Cd concentrations were not affected by the treatment. Blood concentrations reflected the concentrations of Pb, Cr and Cd in Ash.
Transfer into organs
- Transfer type:
- other: gastrointestinal tract/blood
- Observation:
- slight transfer
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
See Figures 3, 6, and 9 in Appendix E of the Study Report.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of result: low bioaccumulation potential based on study results. Systemic bioavailability of heavy metals (Pb, Cr, Cd) from Ash is very low. Blood concentrations reflected the concentrations of Pb, Cr and Cd in Ash.
- Executive summary:
Concentration of 3 indicator metals (Cr, Cd, Pb) in blood were analysed in 2 male and 2 female satellite animals on study days 1, 14 and 28. Samples were taken from the same animals predose, 1h and 6h after dosing; on study day 14 only predose. Blood Pb concentrations showed dose-dependent increases and modest accumulation during the study so that the predose values on day 28 were about 1, 1, 2.5 and 4.5 µg/l in males and 1, 2, 4 and 7.5 µg/l in females at dose-levels of 0, 500, 1000 and 2000 mg/kg/day, respectively. Cr concentrations showed at most only very slight increases and virtually no accumulation. Cd concentrations were not affected by the treatment.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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