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EC number: 278-934-5 | CAS number: 78521-39-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study in accordance with OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- ASC plus
- IUPAC Name:
- ASC plus
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch No.: 110526S
Expiry date: 26.05.2013
Purity: 99.24% (taken as 100%)
Instructions for storage: Room temperature, tighly closed container, cool, dry, only in original container
State of material: crystalline, damp, not dusty
Colour: white
Odour: odourless
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Strain: Rat Wistar SPF Charles River Germany D- 97633 Sulzfeld- Facility,
Species: Rattus norvegicus ssp.alba
- Age at study initiation:8-9 weeks
- Weight at study initiation:180g-230g
Environmental conditions were monitored and recorded continuously over the study. The temperature in the animal room was in-between 20°C and 24°C and the relative humidity was in-between 40% and 70% . A 12/12h light/dark cycle was set.
During the study, the study rats were housed in TECHNIPLAST cages Type 2145 F. The cages measured 480 x 265x 210 mm (floor area 940 cm2). As bedding, sterilized sawdust was used. Two and three animals were housed per cage, respectively.
Diet and water:
For feeding, a standard pelleted diet from Bonagro a.s. CZ10174, Czech Republic was used.
Drinking water from the public water supply was offered in water bottels ad libitum. Water bottels were changed daily.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- administration volume: 10 ml/kg bw.
maximum administration volume: 100 ml/kg bw. - Duration and frequency of treatment / exposure:
- single administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
800 and 1600 mg/kg bw
- No. of animals per sex per dose / concentration:
Group Number of animals Substance Concentration Time of sample taking Volume (ml)
1 Blood (1m;1f)
Serum (4 m; 4 f)
Urine (4 m; 4 f) ASC plus 1600mg.kg-1 3h 10ml/kg bw.
2 Blood (1m;1f)
Serum (4 m; 4 f)
Urine (4 m; 4 f) ASC plus 1600mg.kg-1 6h 10ml/kg bw.
3 Blood (1m;1f)
Serum (4 m; 4 f)
Urine (4 m; 4 f) ASC plus 1600mg.kg-1 12h 10ml/kg bw.
4 Blood (1m;1f)
Serum (4 m; 4 f)
Urine (4 m; 4 f) ASC plus 1600mg.kg-1 24h 10ml/kg b.w.
5 Urine (3 m; 3 f)
Faeces (3 m; 3 f) ASC plus 1600mg.kg-1 3h, 6h, 12h, 24h, 168 h 10ml/kg bw.
6 Urine (3 m; 3 f)
Faeces (3 m; 3 f) ASC plus 800mg.kg-1 3h, 6h, 12h, 24h, 168 h 10ml/kg b.w.- Control animals:
- no
- Positive control reference chemical:
- no
- Details on dosing and sampling:
- - Method for identification: HPLC with UV-VIS detector (column: HAMILTON PRP-1,250x4.1 mm 5µm)
Relevant parameters: Limits of detection, Limit of quantification, Uncertainties, Linearity, Precision/Repeatability. - Statistics:
- mean, standard deviation, recovery
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Group Name of animals Laboratory number Dosage of ASC plus in mg.kg-1 Time of sample taking Assay of ASC plus in mg.kg-1
1 ♂1-4 13-001876 1600 3h 18.6
2 ♂5-8 13-001874 1600 6h 1.28
3 ♂9-12 13-001872 1600 12h 0.90
4 ♂13-16 13-001870 1600 24h <0.10
Group Name of animals Laboratorynumber Dosage of ASC plus in mg.kg-1 Time of sample taking Assay of ASC plus in mg.kg-1
1 ♀17-20 13-001877 1600 3h 11.8
2 ♀21-24 13-001875 1600 6h 0.22
3 ♀25-28 13-001873 1600 12h 0.82
4 ♀29-32 13-001871 1600 24h <0.10
Annotation: the samples were weighted, therefore the results are given as mg x kg-1.
- Details on excretion:
- The concentrations of ASC plus in the feces are relatively low. This could be a result of either a rapid degradation in the intestine or a nearly comlete resorption into the body.
The urine concentrations of ASC plus show that relevant amounts of the test article are resorped into the body and excreted via urine in unchanged form.
As only samples and not the complete excretion of urine or feces were taken, a mass bilance from the present data is not possible.
The data from the urine and feces samples are not very consistent. Due to the sampling conditions a cross-contamination cannot be completely excluded. As consequence from the physiological processes forming feces and urine the highest concentrations occur 6 to 12 hours after administration. Even after 168 h traces of the test article can be found.
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
An oral dosage of 1600 mg ASC plus/kg bw was administered to male and female Wistar rats by stomach tube in 10 ml water/kg bw. Blood, serum, urine and feces were analyzed 3, 6, 12 and 24 hours after administration. Additionally examples of urine and feces were taken 168 hours after administration and 3, 6, 12, 24 and 168 h after oral administration of 800 mg ASC plus/kg bw..The most relevant data are the results of the serum analysises.
The serum levels of ASC plus showed a maximum 3 h after administration. Within 24 hours these levels fall beneath the limit of quantitation. Therefore ASC plus has no potential for bioaccumulation.
The data from the urine and the feces are not very consistent. The concentrations of ASC plus showed that relevant amounts of the test article are resorbed into the body and excreted via urine in unchanged form. - Executive summary:
It was possible to establish an analytical method for the determination of ASC Plus in biological fluids.
An oral dosage of 1600 mg ASC plus/kg bw. was administered to male and female Wistar rats by stomach tube in 10 ml water/kg bw. Blood, serum, urine and feces were analyzed 3, 6, 12 and 24 hours after administration. Additionally examples of urine and feces were taken 168 hours after administration and 3, 6, 12, 24 and 168 h after a oral administration of 800 mg ASC plus/kg bw. The most relevant data are the results of the serum analysis.
The serum levels of ASC plus showed a maximum 3 h after administration. Within 24 hours these levels fall beneath the limit of quantitation.
The concentrations of ASC plus in the feces were relatively low. The urine concentrations of ASC plus showed that relevant amounts of the test article are excreted via urine as unchanged substance.
From the present data one can assume that ASC plus is resorped easily after oral administration. Relevant amounts of an oral dosage are excreted unchanged via urine.
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