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EC number: 484-350-3 | 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 08 - October 11, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of temperature of the freezer in which the samples for analyses on the AU400 were stored occurred. These temporary deviations were considered not to have adversely affect the clinical biochemistry results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- Temporary deviations from the maximum level of temperature of the freezer in which the samples for analyses on the AU400 were stored occurred. These temporary deviations were considered not to have adversely affect the clinical biochemistry results.
- Principles of method if other than guideline:
- United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.3050, Repeated dose 28- day oral toxicity study in rodents. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-00-366, July 2000.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Radiagreen RA
- Physical state: Yellow to amber liquid
- Analytical purity: Unknown
- Lot/batch No.: OE70125
- Expiration date of the lot/batch: 25 January 2011
- Stability under test conditions: Stable
- Storage condition of test material: In refrigerator (2-8ºC) in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Propylene glycol, specific gravity 1.036.
- Details on oral exposure:
- Method of administration:
Oral gavage, using a plastic feeding tube. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of formulations were analysed to check homogeneity, stability and accuracy of preparation. See Notox report 485768 for validated analytical method.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
- No. of animals per sex per dose:
- 5
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- Clinical observations:
No mortality occurred during the study period.
There were no clinical signs of toxicity noted during the observation period.
Functional observations:
Hearing ability, pupillary reflex, static righting reflex and grip strength were normal in all animals.
The variation in motor activity did not indicate a relation with treatment.
Body weights:
No toxicologically signficant changes in body weights and body weight gain were noted.
The statis tically significant lower body weight gain of males at 150 and 1000 mg/kg bw/d was of a temporary nature and mean body weight (gain) remained within the range considered normal for rats of this age and strain.
Food consumption:
No toxicologically significant changes in food consumption.
Laboratory findings:
Haematology:
No toxicologically relevant changes occurred in haematological parameters of treated rats.
The statistically significant lower partial thromboplastin time (APTT) and lower relative eosinophil counts of males and females at 1000 mg/kg/day respectively, were of a minor nature and within the range considered normal for rats of this age and strain. Control partial thromboplastin time
values of males were considered to be slightly high. Therefore, these minor statistically significant differences were considered not to represent a change of toxicological significance.
Clinical biochemistry:
No toxicologically relevant changes occurred in clinical biochemistry parameters of treated rats.
The statistically significant higher inorganic phosphate level of males at 1000 mg/kg/day occurred in the absence of a clear dose-related response, and the mean was within the range considered normal for rats of this age and strain. No toxicological relevance was therefore ascribed to this
change.
Effects in organs:
Necropsy did not reveal any toxicologically relevant alterations.
Organ weights and organ to body weight ratios of treated animals were considered to be similar to those of control animals.
There were no microscopic findings recorded which could be attributed to treatment with the test substance.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects at highest dose tested (original NCD unit is mg/kg/day)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Comments:
No toxicologically significant changes in body weights and
body weight gain were noted.
No toxicologically significant changes in food consumption
before or after allowance for body weight were noted.
Applicant's summary and conclusion
- Conclusions:
- A NOAEL for Radiagreen RA of >=1000 mg/kg/day was established.
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