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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
Repeated dose toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- -
- EC Number:
- 472-110-0
- EC Name:
- -
- Cas Number:
- 71868-15-0
- Molecular formula:
- C20H22O5
- IUPAC Name:
- 2-hydroxy-1-{4-[4-(2-hydroxy-2-methylpropanoyl)phenoxy]phenyl}-2-methylpropan-1-one
- Test material form:
- solid
- Details on test material:
- - Appearance: white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd
Administration / exposure
- 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
Results and discussion
Results of examinations
- 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.
Effect levels
- 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
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
Applicant's summary and conclusion
- 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).
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