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EC number: 278-928-2 | CAS number: 78491-02-8
- 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 to rodents is low: LD50 >2000 mg/kg.
Acute dermal toxicity to rabbits is low: LD50 >2000 mg/kg.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported study performed under GLP and following a standard test method.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Males 257-297g, females 226-255g bodyweight.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- Animals fasted for 16-20h pre-dose.
- Doses:
- 2000 mg/kg only.
- No. of animals per sex per dose:
- 5 males, 5 females
- Details on study design:
- Rats observed 1, 2 and 4h post dose (Day 0), then daily for 14 days (with mortality checks twice daily).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 reported as approximately 2000 mg/kg: 2/5 males and 2/5 females died following administration of this dose.
- Mortality:
- 1 male, 2 females died on the day of dosing. 1 male died the following day.
- Clinical signs:
- other: Diarrhoea and anogenital soiling were seen in all treated animals.
- Gross pathology:
- Abnormalities of the liver, adrenals and gastrointestinal tract were seen in decedents.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observed mortality following oral administration of 2000 mg/kg, the acute LD50 is concluded to be close to, but above, 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- All studies used to conclude the acute oral LD50 value are considered reliable (Klimisch scores 1 or 2).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported study performed under GLP and using a standard test method.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Bodyweights 2.1-3.0 kg males, 2.3-2.4 kg females pre-test.
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- patch and test material moistened with distilled water (0.2 ml)
- Details on dermal exposure:
- Moistened test substance applied to previously clipped test sites (dorsal skin, ca. 10% of body surface area) then covered with gauze, plastic sheet and tape.
- Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- not required
- Details on study design:
- Dressings removed after 24h and test sites subsequently washed with distilled water. Test sites observed 1, 7 and 14 days post-treatment. Animals observed 1, 2 and 4h post-treatment, then daily up to 14 days.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths occurred and no significant evidence of systemic toxicity was observed.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: One day after treatment, 2 females showed minor (grade 1) skin reactions at test sites; in one of these, the reactions persisted to day 7. No clear indications of systemic toxicity was observed (only sporadic observations of reduced faecal production were
- Gross pathology:
- No abnormal observations were reported at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Low dermal toxicity was recorded in this study: acute dermal LD50 in the rabbit >2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The key study employed a standard EPA test method and was performed under GLP (Klimisch 1).
Additional information
In addition to the studies of acute toxicity via oral, inhalation and dermal routes, a study using mice showed relatively low toxicity via intraperitoneal injection (combined sexes LD50 981 mg/kg).
Justification for selection of acute toxicity – oral endpoint
Three studies of acute oral toxicity in the rat are available. Studies of the test substance itself reported LD50 (combined sexes) values of 2570 g/kg and approximately (just above) 2000 mg/kg, with no indication of a sex-related difference in response. A study using an aqueous solution reported LD50 values for males and females which correspond respectively to substance LD50s of 2100 and 1450 mg/kg. A study using mice reported comparable acute oral toxicity in males and females, with a combined sexes LD50 of 3703 mg/kg. Taking a weight of evidence approach, it is concluded that the acute oral LD50 of the substance in rodents is >2000 mg/kg.
Justification for selection of acute toxicity – inhalation endpoint
The 4.5h LC50 value reported in the available study is considered unreliable, due to experimental and reporting deficiencies (but it may suggest relatively low toxicity). Acute inhalation toxicity is assessed by extrapolation from the acute oral toxicity data (using route-to-route conversion calculations).
Justification for selection of acute toxicity – dermal endpoint
LD50 >2000 mg/kg determined in a reliable key study.
Justification for classification or non-classification
Acute toxicity via oral and dermal routes is low and no classification in respect of this is warranted.
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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