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EC number: 406-040-9 | CAS number: 125643-61-0
- 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:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 406-040-9
- EC Name:
- -
- Cas Number:
- 125643-61-0
- Molecular formula:
- C17 H25 O3 R, Where R = (C7 H15) or (C8 H17) or (C9 H19)
- IUPAC Name:
- C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: dest. water with 4% sodium carboxymethylcellulose and 0.2% Tween 80
- Details on oral exposure:
- Method of administration: feeding tube
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 50, 250 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 5 mg/kg bw/day
Male: 10 animals at 50 mg/kg bw/day
Male: 10 animals at 250 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 5 mg/kg bw/day
Female: 10 animals at 50 mg/kg bw/day
Female: 10 animals at 250 mg/kg bw/day - Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical observations:
No premature deaths occurred. The general condition and the body of the animals were unaffected.
Laboratory findings:
Haematologically and biologically, no treatment-related toxic changes were found.
Effects in organs:
At the end of the trial, a reversible absolute and relative liver weight increased was observed in the animals of the high dose group. Macroscopic assessment determined no assessment-related body changes. Microscopically a centrolobular hypertrophy of hepatocytes, was noted in animals of the high dose group in the liver; this was totally reversible in the observation period. In both sexes of the high and the low and medium dose group hypertrophy was noted in the thyroid gland. These changes were all fully reversible in the course of the recovery period, and are considered to be adaptive, reversible alterations. All further findings corresponded to the spontaneous pathological spectrum of the age range of the species.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified. Effects noted where due to adaptations that were fully reversible following cessitation of the study.
- Executive summary:
NOAEL 5 mg/kg bw/day (nominal)
Effects noted where due to adaptations that were fully reversible following cessitation of the study. The substance is not classified; this conclusion has been reviewed previously under the 7th Amendment "Notification" Scheme and the conclusion is that the substance is "not classified" for this effect.
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