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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
Key study: Acute oral: Experimental results: Similar to OECD guideline 401.
LD50 = 12900 mg/kg bw
Key study: Acute dermal: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
LD50 = 6450 mg/kg bw
Key study: Acute inhalation: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
LC50 = 50 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: yes, fasted for 24 h - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 4000, 8000, 10000, 12500, 16000, 20000 and 32000 mg/kg
- No. of animals per sex per dose:
- Five animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: Two weeks
- Frequency of observations: Animals were observed daily.
- Necropsy of survivors performed: No postmortem, or histopathology examinations were performed in this particular study. - Key result
- Dose descriptor:
- LD50
- Effect level:
- 12 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 11 500 - 14 400
- Dose descriptor:
- LD0
- Effect level:
- 10 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other: Ruffled, unkempt coats were evident at 4000 mg/kg. Lethargy, unkempt coats and nasal hemorrhage were prevalent in the animals dosed at 8000 mg/kg and 10000 mg/kg. Staggering gait, impaired locomotion, lethargy and nasal hemorrhage were noted at levels of
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was determined to be 12900 mg/kg.
- Executive summary:
An acute oral toxicity was performed using albino male and female rats. The oral LD50 was determined to be 12900 mg/kg (95% confidence limits = 11500 -14400 mg/kg).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 12 900 mg/kg bw
- Quality of whole database:
- Klimisch 2. Non-GLP study.
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.
- 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.
- GLP compliance:
- no
- Test type:
- other: extrapolation
- Key result
- Dose descriptor:
- LC50
- Effect level:
- 50 mg/L air (nominal)
- Clinical signs:
- other:
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the assumptions for the extrapolation from the acute oral toxicity data, the 4 -h LC50 would be 50 mg/l.
- Executive summary:
From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is 12900 mg/kg bw and the LD0 is 10000 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 10000 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 the oral LD50 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 50 mg/l. Therefore, the 4 -h LC50 would be 50 mg/l.
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 available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is 12900 mg/kg bw and the LD0 is 10000 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 10000 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 the oral LD50 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 50 mg/l. Therefore, the 4 -h LC50 would be 50 mg/l.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 50 mg/m³ air
- Quality of whole database:
- Klimisch 2. Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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.
- 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.
- GLP compliance:
- no
- Test type:
- other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 6 450 mg/kg bw
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the assumptions for the extrapolation from the acute oral toxicity data, the dermal LD50 would be 6450 mg/kg bw.
- Executive summary:
From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is 12900 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 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be 6450 mg/kg bw.
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 dermal route.
From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is 12900 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 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be 6450 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 450 mg/kg bw
- Quality of whole database:
- Klimisch 2. Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
Additional information
Key study: Acute oral: Experimental results: Similar to OECD guideline 401.
LD50 = 12900 mg/kg bw
Key study: Acute dermal: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
LD50 = 6450 mg/kg bw
Key study: Acute inhalation: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
LC50 = 50 mg/L
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – inhalation endpoint
Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
Justification for selection of acute toxicity – dermal endpoint
Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
Justification for classification or non-classification
Based on the available data, the substance is not classified for acute toxicity:
LD50 oral > 2000 mg/kg bw
LD50 dermal > 2000 mg/kg bw
LC50 inhalation > 5 mg/L
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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