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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
Acute oral toxicity: Key study: Based on read-across approach from analogue substance P0310, the LD50 of the substance P-1057 is calculated to be greater than 2490 mg/kg bw.
Acute dermal toxicity: Key study: Based on read-across approach from analogue substance P0310, the LD50 of the substance P-1057 is calculated to be greater than 2490 mg/kg bw.
Acute inhalation toxicity: Key study: Based on the assumptions for the extrapolation from the acute oral toxicity data, the inhalation 4-h LC50 would be greater than 12.45 mg/l.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across approach from experimental data (study according to OECD 423 and GLP) on an analogue substance.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 490 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Based on a read-across from an analogue substance.
- Interpretation of results:
- other: Not classified based on CLP criteria.
- Conclusions:
- Based on read-across approach from analogue substance P0310, the LD50 of the substance P-1057 is calculated to be greater than 2490 mg/kg bw.
- Executive summary:
Based on experimental results obtained in a study according to OECD 423 on analogue substance P0310 where the LD50 for female rats was determined to be greater than 2000 mg/kg bw, the read-across approach is applied and the LD50 for the substance P-1057 is determined to be greater than 2490 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 490 mg/kg bw
- Quality of whole database:
- Key study: Read across from a high quality study (Klimish score =1) performed with an analogue substance.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: extrapolation from results obtained by the oral route
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Test type:
- other: extrapolation
- Key result
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- > 12.45 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Interpretation of results:
- other: Not classified based on CLP criteria.
- Conclusions:
- Based on the assumptions for the extrapolation from the acute oral toxicity data, the inhalation 4-h LC50 would be greater than 12.45 mg/l.
- Executive summary:
Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route.
From the read-across approach, it is concluded that the oral LD50 for the substance is greater than 2490 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.
Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 2490 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of 2490 mg/kg bw is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 12450 mg/m3 (12.45 mg/l). Therefore, the 4 -h LC50 would be greater than 12.45 mg/l (dust/particles inhalation).
Reference
Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route.
From the read-across approach, it is concluded that the oral LD50 for the substance is greater than 2490 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.
Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 2490 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of 2490 mg/kg bw is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 12450 mg/m3 (12.45 mg/l). Therefore, the 4 -h LC50 would be greater than 12.45 mg/l (dust/particles inhalation).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 12 450 mg/m³
- Quality of whole database:
- Key study: Extrapolation from a read across from a high quality study (Klimish score=1) from an analogue substance.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across approach from data on an analogue substance.
- Test type:
- standard acute method
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 490 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Based on a read-across from an analogue substance.
- Interpretation of results:
- other: Not classified based on CLP criteria.
- Conclusions:
- Based on read-across approach from analogue substance P0310, the LD50 of the substance P-1057 is calculated to be greater than 2490 mg/kg bw.
- Executive summary:
Based on experimental results obtained in a study according to OECD 402 on analogue substance P0310 where the LD50 for male and female rats was determined to be greater than 2000 mg/kg bw, the read-across approach is applied and the LD50 for the substance P-1057 is determined to be greater than 2490 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 490 mg/kg bw
- Quality of whole database:
- Key study: Read across from a high quality study (Klimish score =1) performed with an analogue substance.
Additional information
Acute oral toxicity: Key study: Based on experimental results obtained in a study according to OECD 423 on analogue substance P0310 where the LD50 for female rats was determined to be greater than 2000 mg/kg bw, the read-across approach is applied and the LD50 for the substance P-1057 is determined to be greater than 2490 mg/kg bw.
Acute dermal toxicity: Key study: Based on experimental results obtained in a study according to OECD 402 on analogue substance P0310 where the LD50 for male and female rats was determined to be greater than 2000 mg/kg bw, the read-across approach is applied and the LD50 for the substance P-1057 is determined to be greater than 2490 mg/kg bw.
Acute inhalation toxicity: Key study: Based on the assumptions for the extrapolation from the acute oral toxicity data, the inhalation 4-h LC50 would be greater than 12.45 mg/l.
Justification for classification or non-classification
Based on the available information, the substance is not classified for acute toxicity according to CLP criteria.
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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