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Diss Factsheets
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EC number: 205-447-7 | CAS number: 141-01-5
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity oral
In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.
Acute toxicity inhalation
The study doesnot need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver
Acute toxicity dermal
The study doesnot need to be conducted because skin contact in production and/or use is not likely. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from handbook
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of the test chemical in rats
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 3850 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 850 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50 % mortality observed
- Mortality:
- 50 % mortality was observed in treated rats
- Clinical signs:
- not specified
- Body weight:
- not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.
- Executive summary:
In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 850 mg/kg bw
- Quality of whole database:
- Klimisch Rating 2
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because skin contact in production and/or use is not likely
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- waiver
Additional information
Acute toxicity oral
Various studies have been reviewed to evaluate the oral toxicity potential of the test chemical. These include in vivo experimental studies performed on rats as well as mice for the test chemical. The results are mentioned below:
In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.
This result is supported by another similar acute oral toxicity study where,rats were treated with the test chemical orally. No mortality was observed in treated rats at 2300 mg/kg bw. Therefore, LD50 was considered to be greater than 2300 mg/kgbw when rats were treated with the test chemical orally.
The above results are further strengthened by a similar acute oral toxicity study where, WAG albino male rats were treated with the test chemical orally. 50 % mortality was observed at 580 mg/kg. Therefore, LD50 was considered to be 580 mg/kg when WAG albino male rats were treated with the test chemical orally.
All of the above results are supported by an acute oral toxicity study performed on mice. The metal content [Fe] present in the test chemical was 33%. The test chemical was given as an aqueous suspension containing 0.1% w/v of tragacanth. Groups of 10 male fawn mice (GFF strain, bodyweights 17 to 22 gm. ) were dosed orally and then observed for seven days, when the percentage mortalities were recorded. The LD50 values, which were calculated according to do Beer (1945) and expressed in nig. Fe/Kg. LD50 was considered to be 630 mg/kg when Fawn GFF male mice were treated with the test chemical orally.
Eventhough some studies indicate that the test chemical can cause toxicity to standard test organisms when dosed orally, but majority of the studies point out to the fact that the test chemical is non toxic. Hence, the acute oral LD50 for the test chemical can be considered to be greater than 2000 mg/kg and can be classified under the category “Not Classified” as per CLP Regulation.
Acute toxicity inhalation
The study doesnot need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver
Acute toxicity dermal
The study doesnot need to be conducted because skin contact in production and/or use is not likely. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver.
Justification for classification or non-classification
Based on the available results, the test chemical can be regarded as non-toxic when dosed via oral, inhalation, dermal route of exposure. Hence, it can be classified under category "Not Classified" as per CLP Regulation.
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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