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EC number: 203-721-0 | CAS number: 109-94-4
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Food Flavourings and Compounds of Related Structure.II. Subacute and Chronic Toxicity
- Author:
- E. C. HAGAN et al
- Year:
- 1 967
- Bibliographic source:
- Food and cosmetics toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Subacute repeated toxicity study of test substance orally in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl formate
- EC Number:
- 203-721-0
- EC Name:
- Ethyl formate
- Cas Number:
- 109-94-4
- Molecular formula:
- C3H6O2
- IUPAC Name:
- ethyl formate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Housed individually in wire cages.
- Diet (e.g. ad libitum): food ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period:No data available
ENVIRONMENTAL CONDITIONS
No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: Fresh diets were made by mixing test substance.
DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Rat diet were used
- Concentration in vehicle: 0, 1000, 2500 and 10,000 ppm
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kg-bw/day
- Remarks:
- 0 ppm
- Dose / conc.:
- 50 other: mg/kg-bw/day
- Remarks:
- 1000 ppm
- Dose / conc.:
- 125 other: mg/kg-bw/day
- Remarks:
- 2500 ppm
- Dose / conc.:
- 500 other: mg/kg-bw/day
- Remarks:
- 10000 ppm
- No. of animals per sex per dose:
- Total: 80
0 ppm: 10 male and 10 female
50 ppm: 10 male and 10 female
125 ppm: 10 male and 10 female
500 ppm: 10 male and 10 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Details on study design
- Dose selection rationale: No data available
- Rationale for animal assignment (if not random): Animals were randomized by weight (every level having animals of equal weight).
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included: Mortality was observed.
DETAILED CLINICAL OBSERVATIONS: Yes
–Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available.
FOOD EFFICIENCY:
No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At termination.
- Anaesthetic used for blood collection: No data available.
- Animals fasted: No data available.
- How many animals: No data available.
- Parameters checked in table [No.?] were examined: White cell counts, red cell counts, hemoglobin and haematocrits were examined.
CLINICAL CHEMISTRY: No data available
URINALYSIS: No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
OTHER:
Organ weight: Yes
Organs weighted:
Liver, kidneys, spleen, heart and testes were weighed. - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes, Necropsied with the process of exsanguinean.
Abnormalities, gross changes and the suspected reason for death were noted.
HISTOPATHOLOGY: Yes,
Organs were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin.
A detailed microscopic examination in the study was done on 6 or 8 rats, evenly divided by sex, from the high dose group and the control group. If changes attributable to the test compound were found in the high dose group, additional animals on lower dosage levels were examined as indicated. So microscopic examination was not performed for 1000 and 2500 ppm dose level.
Organs examined: Liver, kidneys, spleen, heart, testes, and thoracic viscera, one hind leg, for bone, bone marrow and muscle were examined. - Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effect were observed on growth of treated rat as compared to control.
- Mortality:
- no mortality observed
- Description (incidence):
- No effect on survival were observed in treated rat as compared to control.
- Body weight and weight changes:
- not specified
- 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
- Description (incidence and severity):
- No effect were observed on hematological parameters of treated rat as compared to control.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological abnormalities were observed in treated rat as compared to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No microscopic changes in the tissues were observed in treated rat as compared to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Pathological changes attributable to disease or age have not been included.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- Remarks on result:
- other: No effect observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 500 mg/kg body weight/day when Osborne-Mendel male and female rats treated with tes substance for 17 week by oral feed.
- Executive summary:
In a Chronic repeated dose oral toxicity study, Osborne-Mendel male and female rats treated with test substance in the concentrations of50, 125 and 500mg/kg bw orally in diet. The animals were observed for clinical sign, body weight, food consumption, Hematology, gross and Histopathology. Results show that no effect was observed on survival and growth of all the treated rats. Similarly, no effect was observed on hematological parameters of treated rat as compared to control. In addition, No gross pathological abnormalities and microscopic changes in the tissues were observed in all treated rat as compared to control. Therefore, NOAEL was considered to be 500 mg/kg body weight/day when Osborne-Mendel male and female rats treated with test substance for 17 weeks by oral feed.
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