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Diss Factsheets
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EC number: 274-324-8 | CAS number: 70131-50-9
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- December 2005 - April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented with detailed methodology
Data source
Reference
- Reference Type:
- publication
- Title:
- NovaSil clay intervention in Ghanians at high risk of aflatoxicosis. I. Study design and clinical outcomes
- Author:
- Afriyie-Gyawu, Ankrah NA, Huebner HJ, Ofosuhene M, Kumi J, Johnson NM, Tang L, Xu L, Jolly PE, Ellis WO, Ofori-Adjei D, Williams JH, Wang JS & Philips TD
- Year:
- 2 008
- Bibliographic source:
- Food Additives and Contaminants, 25(1): 76-87
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- repeated dose toxicity: oral
- Principles of method if other than guideline:
- A 3 month double-blind and placebo controlled phase IIa clinical trial was conducted in Ghana to investigate the safety, tolerance and aflatoxin-sorption of dietary NovaSil (NS). As a precursor to a human clinical trial with NS in Ghana a short term ( 2 weeks) study was conducted to evaluate the safety and tolerance of NS capsules in 50 helathy human volunteers (Section 7.10.3 Wang 2005)
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): NovaSil clay (NS)
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 177
- Sex: Male and female
- Age: 18-58 years
- Race: African
- Demographic information: Ghana
- Known diseases: No history of chronic disease - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- oral
- Reason of exposure:
- intentional
- Details on exposure:
- Subjects were randonly divided into three treatment groups: high dose (HD) who recieved 2 capsules containing 500 mg NS, low dose (LD) who received 250 mg NS or placebo (PL) who received 250mg placebo, three times a day over a period of three months. In total the HD and LD groups received 3.0 and 1.5 g NS per day. As a safety precuation, 3.0 g NS was selected as the highest dose since it represented the MED (minimal effective dose) of NS for AFs based on previous animal studies.
- Examinations:
- After three month sof capsule ingestion subjects were monitored without NS for another month. At the end of the fourth month, participants underwent final physical examinations and blood and urine specimens were collected for analysis. Urine samples were analyzed for an acute biomarker of AF exposure, AFM1. AFB1-albumin adducts, another biomarker delineating long-term exposure to AFs was measured in serum.
Results and discussion
- Clinical signs:
- Symtoms included nausea, vomiting, diarrhea, abdominal discomfort, heartburn and dizziness. Over 50% of the symptoms occurred during the first two weeks and the rest reported intermittently afterwards until the end of teh study.None of the effects appeared dose dependent or NS-related except for the episode of nausea.
- Results of examinations:
- In the hematological analysis there were no significant, dose-dependent effects in any of the parameters among the three treatment groups, either before or after the 3 month trial.
Analysis if serum biochemistry indicated isolated statistically significant differences in a few parameters.
Applicant's summary and conclusion
- Conclusions:
- Results of the study indicate that administration of NS capsules ( 1.5 and 3.0 g day) over a 3 month period was apparently safe, as evidenced by physical examinations, hematological and biochemical parameters.
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