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EC number: 218-216-0 | CAS number: 2082-79-3
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline without GLP, acceptable with restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Details on test material:
- - Physical state: white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RAI f
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred on the premises of CIBA-GIEGY limited
- Age at study initiation: 5-6 weeks
- Weight at study initiation: males 174-178 g; females 172-176 g
- Housing: 5/cage
- Diet (e.g. ad libitum): pelleted standard diet, Nafag No. 890 (NAFAG, Gossau SG, Switzerland)
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 15
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- clean air
- Remarks on MMAD:
- MMAD / GSD: Particle size analysis of the chamber airborne particles showed that > 70 % were smaller than 7 micron in diameter (20 to 30 % above 7 µm; 30 to 40 % 3-7 µm; 25 to 35% 1-3 µm; 15-25 % 0-1 µm)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- According to the method of Sachsse et al. (In: Proceedings of the Europ. Soc. for the Study of Drug Toxicity. Vol. XV, pp. 239-251, Zurich, June 1973)
- Method of holding animals in test chamber: The animals were kept separately in PVC tubes which were positioned radially around the exposure chamber.
- System of generating particulates/aerosols: The test article was generated as a dust in three different amounts with the help of a Grafix Exaktomat Injector (Cerutti AG., Bern, Switzerland) into an airstream discharged into the exposure chamber through a nozzle under a pressure of 2 atm, at a rate of 20 L/min.
- Temperature, humidity in air chamber: ca. 25 °C, 43-61 %
- Method of particle size determination: Gravimetrically with a 4 stage Cascade Impactor on selectron filters, pore size 0.2 um and 25 mm diameter (Schleicher und Schuell, Feldbach, Switzerland)
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetrically on selectron filters, pore size 0.2 um and 50 mm in diameter (Schleicher und Schuell, Feldbach, Switzerland)
- Samples taken from breathing zone: yes, in the vicinity of the animals throughout the exposure time - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- 6 h/day, 5 times/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
23±3, 128±8, 543±12 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Post-exposure recovery period in satellite groups: 21 days (all groups)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: mortality, symptoms
BODY WEIGHT: Yes
- Time schedule for examinations: daily, except weekends
FOOD CONSUMPTION:
- Food consumption for each animal determined: Yes, twice weekly
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: weekly
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at test day 21
- Anaesthetic used for blood collection: No
- Animals fasted: Yes, overnight
- How many animals: 5 males and 5 females
- Parameters checked: Haemoglobin (Hb), Methaemoglobin (MHb), Erythrocytes (RBC), Packed Cell Volume (PCV), Mean Corpuscular Volume (MCV), Mean Corpuscular Haemoglobin (MCH), Reticulocytes, Inclusion Bodies (Heinz Bodies), Thrombocytes, Prothrombin Time, Activated Partial Thromboplastin Time, Leucocytes (total count and differential count)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at test day 21
- Animals fasted: Yes, overnight
- How many animals: 5 males and 5 females
- Parameters checked: Glucose, Urea (Urea-N), Glutamate-Oxalacetate Transaminase (GOT), Glutamate-Pyruvate Transaminase (GPT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (AP), Y-Glutamyl Transpeptidase (y-GT), Total Protein, Protein Electrophoresis, Electrolytes (Na, K) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- The following organs were weighed: heart, lungs, liver, kidneys, adrenals, thymus, brain, gonads. Organ to body weight and organ to brain weight ratios were calculated for each of these organs.
- Statistics:
- - for Laboratory Investigations, Student's "t" test and the analysis of variance were employed to assess the significance of difference between concentration groups and controls whenever indicated.
- for others than Laboratory Investigations, a uni-variate statistical analysis was conducted.
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):
- effects observed, treatment-related
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
During the exposure and recovery period no toxic symptoms were observed in the rats of the test and control groups.
BODY WEIGHT AND WEIGHT GAIN:
No differences in the bodyweights were observed in the rats of the test and control groups during the exposure and recovery period.
FOOD CONSUMPTION:
There was only a slight but significant (sign.l = 0.01) reduction of food consumption in male rats of highest dose group at day 13 of the exposure period.
FOOD EFFICIENCY:
The mean food conversion of all treated rats was comparable to that of the controls during the 21-day exposure and the following recovery period.
OPHTHALMOSCOPIC EXAMINATION:
No ocular changes were observed
HAEMATOLOGY:
The observed haematological findings between treated rats and controls were generally unremarkable.
CLINICAL CHEMISTRY:
In the assessment of blood chemistry values the findings were unremarkable and comparable to those of the controls.
ORGAN WEIGHTS:
There were no obvious differences in absolute organ weights, organ to body weight and organ to brain weight ratios between the treated and control rats.
GROSS PATHOLOGY:
No compound related gross anatomical changes were noted in the treated animals.
HISTOPATHOLOGY: NON-NEOPLASTIC:
All microscopical findings were only incidental in nature and not related to treatment.
Effect levels
- Dose descriptor:
- NOEC
- Effect level:
- >= 543 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects at the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no reactions to treatment for all the parameters investigated. It can be inferred from the observations made during the above study that the "no observable effect level" is above 543 mg/m3 air for male and female rats.
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