Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- Adequacy of study:
- key study
Data source
Reference
- Reference Type:
- other: Assessment of toxicokinetic behaviour
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- review based on the current knowledge of the substance: Molecular weight, vapour pressure, octanol/water partition coefficient, water solubility. The available acute oral (Bradshaw, 2011 - report No. 41101792) and eye irritation (Bradshaw, 2011 - report No. 41102090) studies, the twenty-eight day study (Dhinsa, 2012 - 41101789). The mutagenicity studies (Thompson, 2011 - report No. 41102091, Lacey, 2011 - report no. 41101786), Flander, 2012 - report no. 41101787, Flander, 2012 - report no. 41202876) and the skin sensitising study (Bradshaw, 2011 - report No. 41102091). For further details on all the studies listed, refer to the current dossier in the relevant sections.
- GLP compliance:
- no
- Remarks:
- Not applicable
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Toxicokinetic Assessment based on the structure of the molecule of the substance (refer to the reference substance of the current dossier)
and the following criteria:
* Molecular Weight: 458.38 g/mol
* Water Solubility: 0.326 mg/L
* Vapour Pressure: 5.4 x10-13 Pa at 25°C
* Partition Coefficient: log Pow 2.36
* Acute Oral Toxicity: LD50 > 2000 mg/kg bw
* Acute Dermal (Limit Test): LD50 > 2000 mg/kg bw
* Acute Dermal irritation: Non irritant to rabbit skin
* Acute Eye Irritation: Mild irritant (classified)
* Skin Sensitization: Negative
* 28 Day Repeated dose
NOAEL Systemic toxicity - 1000 mg/kg bw/day
NOEL Systemic toxicity - 30 mg/kg bw/day
NOEL Neurotoxicity - 1000 mg/kg bw/day
* Ames test: Negative
* Chromosomal Aberration Test: Negative
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Not applicable
Administration / exposure
- Duration of exposure:
- Not applicable
- Doses:
- Not applicable
- No. of animals per group:
- Not applicable
- Details on study design:
- Not applicable
- Details on in vitro test system (if applicable):
- Not applicable
Results and discussion
- Absorption in different matrices:
- * Absorption
Although the test item is moderately lipophilic in nature the relative small molecular size of the substance should also allow absorption through passive diffusion. Results of the twenty-eight day repeated dose study in rats showed evidence to support the gastric absorption of the test item (Dhinsa, 2012). This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. Limited absorption may also take place via the skin due to the relative small molecular size.
The low vapour pressure value (5.4 x 10-13 Pa at 25°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.
* Distribution
Systemic distribution is evident from the twenty-eight day repeated dose study (Dhinsa, 2012) as a result of the organ changes observed. The lack of evidence to suggest the test item is a skin sensitizer suggests that it does not bind to carrier proteins in the circulatory system (Bradshaw, 2011). The moderately lipophilic nature of the test item suggests that bioaccumulation in body fat is unlikely.
* Metabolism
The results of the twenty-eight day repeated dose study showed evidence of an adaptive response in the liver in rats (Dhinsa, 2012); which is normally associated with enhanced metabolism. The test item was non-mutagenic and results of the genotoxicity assays have shown that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising system (Thompson, 2011).
* Excretion
Poor water-soluble products are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this material. However as there is evidence of hepatic metabolism which suggests urinary excretion cannot be ruled out. The results of the twenty-eight day repeated dose study did show evidence of this as a potential route of excretion. The main reason for xenobiotic metabolism is to render the product more water soluble thereby allowing urinary excretion. Any test item that is not absorbed from the gut will be excreted in the faeces.
Applicant's summary and conclusion
- Conclusions:
- Based on the data currently available for the test item, it is suggested that absorption of the test substance from the gastrointestinal tract can take place. Some absorption may also take place via the skin. Once absorbed, the substance would be distributed in the serum. Biliary excretion may well be a significant route for the substance however urinary excretion may also be possible.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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