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EC number: 429-220-9 | CAS number: 132584-17-9
- 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:
- repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 429-220-9
- EC Name:
- -
- Cas Number:
- 132584-17-9
- Molecular formula:
- C17 H18 O4
- IUPAC Name:
- ethyl 2-hydroxy-2-(4-phenoxyphenyl)propanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 73.5%
Batch: IN-JG303-7
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)IGS BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Suspension in 0.5% methyl cellulose
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5/sex/dose level
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- All rats were evaluated for clinical observations, body weights, and food consumption throughout the study. Full functional observational battery (FOB) and motor activity (MA) tests were conducted prior to study start (baseline) and during week 4. An abbreviated FOB was conducted at weekly intervals during weeks 1-3. Prior to terminal sacrifice, blood was taken from each rat and evaluated for hematology and clinical chemistry parameters.
- Sacrifice and pathology:
- All rats were sacrificed on test day 29 and necropsied. All collected tissues from all rats in the 0 and 500 mg/kg/day dose groups were processed and received a full histological examination. Liver, kidney, and lungs were examined from rats in the 15 and 150 mg/kg/day dose groups.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs of wet chin, wet perineum, low arousal, and ptosis were observed at 500 mg/kg/day throughout the study.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gains were decreased in the 500 mg/kg/day male rats.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- Food efficiency were decreased in the 500 mg/kg/day male rats.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There was no evidence that the test substance produced a neurotoxic effect. Forelimb grip strength, hindlimb grip strength, foot splay, and motor activity were unaffected by the test substance. Clinical signs of neurotoxicity were not observed in the study.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean kidney weight relative to body weight was increased 73% in males and 64% in females in the 500 mg/kg/day groups. These increases were test substance-related and correlated with biologically adverse gross and microscopic findings.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The kidneys of the 500 mg/kg/day male and female rats were noted as large, large and pale, or discolored. .
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- A spectrum of lesions occurred in the renal cortex and medulla of both male and female rats dosed at 500 mg/kg/day. Affected kidneys were characterized primarily by dilatation of tubules, regeneration of affected tubular epithelial cells, and the presence of hyaline casts within the collecting ducts
- Details on results:
- Clinical observations:
There were no deaths, but at 500 mg/kg, clinical signs in
both both males and females included wet chin, wet perineum,
low arousal and ptosis.
Laboratory findings:
There were minor changes in blood chemistry parameters at
500 mg/kg/day, but were not thought to be toxicologically
significant. Some of the observed effects were considered
to be associated with adaptive changes to the kidneys.
There were no adverse effects in other goups.
Effects in organs:
Effects were noted in the kidneys at 500 mg/kg/day,
including lesions to the renal cortex and medulla in males
and females. There was also an increase in the mean kidney
weights at 500 mg/kg/day, with an increase in size
observed, together with discolouration.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Sex:
- male/female
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the NOEL was 150 mg/kg in both males and females based on biochemical and pathological evidence of toxicity in the 500 mg/kg/day males and females.
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