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EC number: 600-872-8 | CAS number: 108419-35-8
- 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:
- 6 October 1983 - 20 October 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- EC Number:
- 283-740-9
- EC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
- Cas Number:
- 84712-50-5
- Molecular formula:
- C15H30O2
- IUPAC Name:
- Acetic acid, C11-14-isoalkyl esters, C13-rich
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS:
SPECIFIC GRAVITY: 0.874 (SUPPLIED BY SPONSOR)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: Approx 10-12 weeks
- Weight at study initiation: 190 - 334 g
- Fasting period before study: 18 hr
- Housing: Group housed by sex, 5 per suspended stainless steel cage
- Diet: Certified Purina rodent chow (ad libitum).
- Water (e.g. ad libitum): Automatic watering system (ad libitum)
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): pprox 12 hours light/dark
IN-LIFE DATES: FROM: OCTOBER 6, 1983 TO: OCTOBER 20,
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
- Doses:
- 5,000 mg/kg
- No. of animals per sex per dose:
- 5 males/females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined for viability once in the horning (before approximately 10:30 am) and once in the afternoon (after approximately 3:00 pm). In-life observations were made as to the nature, onset, severity, and duration of toxicological signs 1, 2, 4, and 6 hours after dosing, and once per day thereafter for a total of 14 days. Body weights were recorded the day prior to dosing (pre-dose), at initiation of dosing, at day 7 and day 14.
- Necropsy of survivors performed: yes. After the day 14 observations, all animals were weighed and euthanized by carbon dioxide asphyxiation. Gross necropsies were performed by qualified personnel. - Statistics:
- The means and standard deviations of the body weights were calculated.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no animals deaths during this study
- Clinical signs:
- other: During clinical in-life observations staining in the ano-genital area was noted for 9 of the 10 test animals on days 1 and 2, and for 1 animal on day 3. Soft stool was noted for 1 animal at 6 hours and white gelatinous material on the penis was noted for
- Gross pathology:
- Gross necropsy observations revealed lung discoloration ranging from a slight amount of dark red foci to mottling of all lobes and surfaces in 4 animals; these are typical findings as a result of carbon dioxide asphyxiation. Six of the 10 test animals exhibited no observable abnormalities during the postmortem examination.
Any other information on results incl. tables
Results tables can be found in the attachment to this RSS
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50> 5,000 mg/kg
- Executive summary:
The acute toxicity of the test substance was evaluated when administered by the oral route at 5,000 mg/kg of fasted body weight to 5 male and 5 female rats. The animals were fasted for approximately 18 hours prior to administration of the test material.
Observations were made as to the nature, onset, severity, and duration of toxicological signs 1, 2, 4, 3 and 24 hours after dosing, and once per day thereafter for a total of 14 days. Body weights were recorded the day prior to dosing, on the day of dosing, on day 7, and on day 14. After the day 14 observations, all animals were weighed and euthanized by carbon dioxide asphyxiation. Gross necropsies were performed on all animals by qualified personnel.
There were no animal deaths noted during the study. The body weights of all but 1 animal increased over the 14 day test period.
Clinical in-life observations included a high incidence of ano-genital staining, and a low incidence of soft stool which were not judged to be treatment related. There appeared to be no treatment related abnormalities on postmortem gross examination of the test animals.
Note: it appears the predose body weight for this animal may be incorrect.
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