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EC number: 244-034-6 | CAS number: 20780-49-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer-reviewed journal.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- RIFM fragrance ingredient safety assessment - Test chemical
- Author:
- Api et al.
- Year:
- 2 017
- Bibliographic source:
- Food and Chemical Toxicology
- Reference Type:
- other: Secondary source
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- USEPA
- Year:
- 2 019
- Bibliographic source:
- HPVIS
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.2650 (90-Day Oral Toxicity in Rodents)
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed to determine the toxic effects of the test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Acetic acid, C7-9-branched alkyl esters, C8-rich
- Cas Number:
- 108419-32-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- Acetic acid, C7-9-branched alkyl esters, C8-rich
- Details on test material:
- - Name of test material (as cited in study report):Acetic acid, C7-9-branched alkyl esters, C8-rich
- Molecular formula (if other than submission substance):C10H20O2
- Molecular weight (if other than submission substance):172.266 g/mole
- Substance type:Organic
- Physical state:Liquid
- Purity:>90%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100, 500, and 1000 mg/kg/day
- Amount of vehicle (if gavage): 1.111 ml/kg - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 90 Days
- Frequency of treatment:
- daily, 5 days/week for 13 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kg/day
- Remarks:
- Control
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- A group of 20 rats/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes, all surviving animals were weighed.
- Time schedule for examinations: after 13 weeks
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes, blood samples were collected from the abdominal aortas.
- Time schedule for collection of blood: following an overnight fast
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: No data
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes, clinical laboratory studies (hematology and serum chemistry) were
Performed.
- Time schedule for collection of blood: after 45 days and at study termination.
- Animals fasted: No data
- How many animals: on 5
animals/sex/dose after 45 days (interim sacrifice), and all animals at study termination.
- Parameters checked in table [No.?] were examined. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, at 45 days, a complete necropsy was performed and livers were collected, weighed and reserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguination. Complete necropsies were performed.
HISTOPATHOLOGY: Yes, microscopic examination was performed. - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Rats produced minimal signs of systemic toxicity.
- Mortality:
- no mortality observed
- Description (incidence):
- There was no treatment-related mortality.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Weekly mean body weights were not significantly altered compared to controls.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Food consumption values were not significantly altered compared to controls.
- Food efficiency:
- not specified
- Description (incidence and severity):
- No data
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- No data
- Ophthalmological findings:
- not specified
- Description (incidence and severity):
- No data
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- The qualitative hematologic data were unremarkable at all dose levels for the interim and terminal evaluations.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- At the terminal sacrifice, there were no biologically significant differences between treated and control animals for the measured clinical chemistries.
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- No data
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- No data
- Immunological findings:
- not specified
- Description (incidence and severity):
- No data
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. All other organ weights were comparable to control values.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy only in the high-dose male rats that were consistent with alpha-2u-globulin effects.
- Neuropathological findings:
- not specified
- Description (incidence and severity):
- No data
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathology review of all other tissues from high-dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix, and corpus of the uterus, and vagina), showed normal morphology.
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- No data
- Other effects:
- not specified
- Description (incidence and severity):
- No data
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day, when male and female Sprague-Dawley rats were exposed to the given test chemical for 90 days.
- Executive summary:
90 days repeated oral toxicity study was performed to determine the toxic nature of the given test chemical. The study was performed using male and female Sprague-Dawley rats at dose level of 0 (water) or 100, 500 or 1000 mg/kg/day. Controls received a dose of water volumetrically comparable to the dosage administered to the high dose group, 1.111 ml/kg. Clinical laboratory studies (hematology and serum chemistry) were performed pretest on 5 males and 5 females (non-study animals), on 5 animals/sex/ dose after 45 days (interim sacrifice), and all animals at study termination. Blood samples were collected from the abdominal aortas following an overnight fast. At 45 days, a complete necropsy was performed and livers were collected, weighed and preserved. After 13 weeks, all surviving animals were weighed, anesthetized and sacrificed by exsanguination. Complete necropsies were performed.
Oral administration of the test chemical daily, 5 days/week for 13 weeks, to rats produced minimal signs of systemic toxicity. There was no treatment-related mortality. The in-life clinical observations were primarily oral and dermal irritation (no clear dose response). Weekly mean body weights and food consumption values were not significantly altered compared to controls. The qualitative hematologic data were unremarkable at all dose levels for the interim and terminal evaluations. At the terminal sacrifice, there were no biologically significant differences between treated and control animals for the measured clinical chemistries. Terminal liver and kidney weights were elevated in a dose-related manner but were considered to be adaptive changes and not indicative of toxic effects. All other organ weights were comparable to control values. Microscopic evaluation of the kidneys showed evidence of mild tubular nephropathy only in the high-dose male rats that were consistent with alpha-2u-globulin effects. Histopathology review of all other tissues from high-dose animals, including reproductive organs (testes, epididymides, prostate, seminal vesicles, ovaries, uterine horns, cervix, and corpus of the uterus, and vagina), showed normal morphology.
Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day, when male and female Sprague-Dawley rats were exposed to the given test chemical for 90 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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