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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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Description of key information
LD50 (oral, rat) > 2000 mg/kg bw (OECD 420, GLP)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar
toxicological properties because they have common structural features in the same relatives positions. Further information is included in attachment to IUCLID section 13.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Impurities present in the target substance are configurational isomers of the main constituents and are therefore not impacting the chemical similarity between the source and target substances. Further information is included in attachment to IUCLID section 13.
3. ANALOGUE APPROACH JUSTIFICATION
The source and the target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action.
The available information on composition, physico-chemistry and toxicity suggests that the substances (source and target) share sufficient common properties, so that read across may be undertaken for the acute oral toxicity endpoint. Further information is included in attachment to IUCLID section 13.
4. DATA MATRIX
Further information is included in attachment to IUCLID section 13. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As the Rat oral LD50 (females) of the source substance is above 2000 mg/kg bw, by read across approach, the target substance is not classified for acute oral toxicity according to regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
The study was performed on a source substance according to OECD 420 and EU Method B1 bis Acute oral Toxicity fixed dose and according to GLP to assess the acute oral toxicity of the test item ST 01 C 11 following a single oral administration.
Groups (5 females/dose) of Wistar (RccHan™:WIST) rats were given a single oral (gavage) dose of test item at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Sighting study was conducted at the dose levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose for main study.
In sighting study, no mortality or clinical signs were observed at 300 and 2000 mg/kg bw. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. In the main study, no mortality was observed at 2000 mg/kg bw. No signs of systemic toxicity were noted during the observation period. All animals showed expected gains in bodyweight over the observation period. Dark liver was noted at necropsy of one animal at 2000 mg/kg bw. No abnormalities were noted at necropsy of the remaining animals.
The Rat Oral derived LD50 (females) of the test item is thus above 2000 mg/kg bw.
The target substance is therefore expected to have and acute oral LD50 of > 2000 mg/kg bw. The target substance is not classified for acute oral toxicity according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- The available information as a whole meets the tonnage driven information requirements of REACH.
Acute toxicity: via inhalation route
Endpoint conclusion
- Quality of whole database:
- The available information as a whole meets the tonnage driven information requirements of REACH.
Acute toxicity: via dermal route
Endpoint conclusion
- Quality of whole database:
- The available information as a whole meets the tonnage driven information requirements of REACH.
Additional information
Justification for classification or non-classification
The registered substance is not classified for acute oral toxicity according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
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.