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EC number: 431-090-3 | CAS number: 190085-41-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 April 1996 to 19 April 1996 (in life)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Act (USA) - 16 CFR 1500.3(c)(2)(i)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 431-090-3
- EC Name:
- -
- Cas Number:
- 190085-41-7
- Molecular formula:
- C19 H30 O3
- IUPAC Name:
- 2-butyloctyl 2-hydroxybenzoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A USDA licensed supplier
- Weight at study initiation: male, 200-300 g; female, 200-300 g
- Fasting period before study: 18 hours
- Housing: in suspended stainless steel wire mesh cages in a temperature controlled room
- Diet (ad libitum): standard laboratory feed for rodent
- Water (ad libitum): city water
- Acclimation period: at least 4 days prior to the start of testing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 deg F +/- 2 deg F
IN-LIFE DATES: From: 5 April 1996 To: 19 April 1996
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was used as received. The test substance was measured by syringe and dosed via syringe and intubation tube. The dose was calculated as follows:
Dose Volume (ml) = Animal Weight (kg) x Dose (g/ml) / Test Material Density or Concentration (g/ml) - Doses:
- 5000 mg/kg bwt
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Test Duration/Observations:
Animals were examined immediately after dosing, 4 hours after dosing, and then twice daily for a maximum of 14 days.
Animal Preparation:
The rats were fasted overnight for approximately 18 hours prior to dosing. Water was available ad libitum.
Types of Observations:
Cageside observations included: skin and fur, eyes and mucous membrane, respiratory system, circulatory system, autonomic and central nervous system, behavior pattern and the onset of tremor, convulsions, salivation, lethargy, sleep and coma.
Gross Pathology:
This was performed on all animals at the time of death. All gross pathological observations were recorded.
Analysis of Data:
The animal's response when exposed to the test substance will include the incidence, severity and reversibility of the following: behavior abnormalities, clinical abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxicological effects.
Evaluation:
As defined in FHSA 16 CFR 1500.3(c)(2)(l), if a dose of 5 g/kg bwt produces no compound related mortality in 5 or more animals, the test material is not considered toxic.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred during the course of this study.
- Clinical signs:
- other: At 4 hours post dosing and on days 1 and 2, all animals had yellow anogenital staining. On days 3 and 4, a single female had yellow anogenital staining and appeared dehydrated on day 3. There were no other clinical observations noted.
- Gross pathology:
- There were no gross abnormalities observed in any of the animals at necropsy.
Applicant's summary and conclusion
- Conclusions:
- The submitted test material when administered as supplied at a single oral dosage level of 5 g/kg bwt did not produce compound-related mortality in half or more of the animals; therefore, the test material is not considered toxic according to definitions listed in the FHSA - 16 CFR 1500.3(c)(2)(l).
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