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Diss Factsheets
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EC number: 472-110-0 | CAS number: 71868-15-0
- 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 value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Annex V B.7, OECD n.407
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- Annex V B.7, OECD n.407
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Hsd
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Water ad inj.
- Details on oral exposure:
- Method of administration:
Gavage of a suspension, using a stomach tube - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 5 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No severe treatment-related clinical signs were observed.
- Mortality:
- no mortality observed
- Description (incidence):
- No animals died during the study.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Bodyweight were affected by treatment in male high dose group
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption were affected by treatment in male high dose group
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Some individual haematology deviations were observed but considered not biologically relevant.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No differences between dosed group and control are observed in urine parameters.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathological findings considered to be direcly treatment-related were observed in the adrenal gland, liver, lung and spleen, in 50 and 150 mg/kg bw dose groups.
After 14 days recover period for High dose group, liver changes were fully reversible and adrenal gland, lung and spleen chenges had almost reversed. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- histopathology: non-neoplastic
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Conclusions:
- Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be 5 mg/kg bw/day.
- Executive summary:
A study was conducted to determine the repeated dose oral toxicity of the test substance according to OECD Guideline 407 and EU Method B.7, in compliance with GLP. Groups of 5 male and female Hsd rats were administered 0, 5, 50 and 150 mg/kg bw/day of test substance by oral gavage for 28 days. There were no treatment-related changes at 5 mg/kg bw/day. No severe treatment-related clinical signs were notede at any dose. Individual haematology deviations were observed but considered not biologically relevant. No significant changes were observed in urine parameters. In the high dose group, feed consumption and body weight were affected in males. Treatment-related histopathological findings were observed in the adrenal gland, liver, lung and spleen, at 50 and 150 mg/kg bw. After 14 days recovery period for the high dose group, liver changes were fully reversible and adrenal gland, lung and spleen changes had almost reversed. Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be 5 mg/kg bw/day (Bioservice, 2007).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5 mg/kg bw/day
- Study duration:
- subacute
- Experimental exposure time per week (hours/week):
- 168
- Species:
- rat
- Quality of whole database:
- The information requirement for this tonnage band is sufficiently met with the available data.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Additional information
A study was conducted to determine the repeated dose oral toxicity of the test substance according to OECD Guideline 407 and EU Method B.7, in compliance with GLP. Groups of 5 male and female Hsd rats were administered 0, 5, 50 and 150 mg/kg bw/day of test substance by oral gavage for 28 days. There were no treatment-related changes at 5 mg/kg bw/day. No severe treatment-related clinical signs were notede at any dose. Individual haematology deviations were observed but considered not biologically relevant. No significant changes were observed in urine parameters. In the high dose group, feed consumption and body weight were affected in males. Treatment-related histopathological findings were observed in the adrenal gland, liver, lung and spleen, at 50 and 150 mg/kg bw. After 14 days recovery period for the high dose group, liver changes were fully reversible and adrenal gland, lung and spleen changes had almost reversed. Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be 5 mg/kg bw/day (Bioservice, 2007).
Justification for classification or non-classification
Based on the result of a repeated dose oral toxicity study (OECD Guideline 407), the test substance does not warrant classification for this endpoint according to EU CLP criteria (Regulation 1272/2008/ EC).
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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