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EC number: 206-323-5 | CAS number: 327-62-8
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- FACTORS AFFECTING THE DISTRIBUTION OF INGESTED PROPIONIC ACID IN THE RAT FORESTOMACH
- Author:
- J. E. BUELD and K. J. NETTER
- Year:
- 1 992
- Bibliographic source:
- Fd Chem. Toxic. Vol. 31, No. 3, pp. 169-176, 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guideline 408 (90 day repaeted dose toxicity study)
- Deviations:
- yes
- Remarks:
- rats were exposed to propionic acid via food either as powedered or pelleted feed for 12 or 20 weeks. The occurrence of hyperplasias in the forestomach and the accumulation of propionic acid were evaluated.
- Principles of method if other than guideline:
- - Principle of test: Exposure of male Wistar rats to 0, 4%, and 8% propionic acid in feed over 12 and 20 weeks respectively, to investigate the occurrence of hyperplasias and the accumulation of propionic acid in the forestomach.
- Short description of test conditions: Groups of six male Wistar rats (approx. 130g) were fed for 24wk a pelleted diet containing 0 or 8% PA . In a second experiment, four groups of male Wistar rats (24 in total; 120-140 g)
were fed either control powdered diet or powdered diet supplemented with 4% PA, 1% L-carnitine or 4%PA and 1% L-carnitine for 12wk. Body weights were taken at the start of the study and weekly thereafter. Food onsumption was determined daily by weighing the containers (after filling and before spilling on the next day at 9 am).
Food spillage was minimized by a special construction of the food containers; therefore it was not considered further. At the end of the study, rats were killed by CO2 inhalation. Parts of the food bolus within the forestomach and glandular stomach were collected and stored at - 20°C to prevent evaporation of PA. The remaining bolus was then removed with icecold saline, and the stomach was flattened and fixed while attached to a piece of cardboard and examined macroscopically. Sections taken parallel to the lesser curvature, including the forestomach, limiting ridge and glandular stomach, were pinned flat in Bouin's solution (saturated picric acid-37% formalin-glacial acetic acid; 15:4:1, by vol.) and prepared for haematoxylin and eosin staining.
- Parameters analysed / observed: macroscopically determination of hyperplasias, accumulation of propionic acid in the forestomach tissues. - GLP compliance:
- no
- Test type:
- other: repeated dose oral toxicity study over at least 84 days
- Limit test:
- no
Test material
- Reference substance name:
- Propionic acid
- EC Number:
- 201-176-3
- EC Name:
- Propionic acid
- Cas Number:
- 79-09-4
- Molecular formula:
- C3H6O2
- IUPAC Name:
- propionic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approx. 130 g in the first experiment and 120-140 g in the second experiment
- Fasting period before study: no
- Housing: In each experiment rats were housed two in Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55-60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- water
- Details on oral exposure:
- For the preparation of food pellets, the appropriate amount of PA was diluted with water before being mixed with the powder. Pellets of about 10 g were pressed and air-dried for at least 3 days but stored not longer than 10 days.
- Doses:
- 0, 4, and 8% in feed
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: n/a; repeated dose study over 12 or 20 wk
- Frequency of observations and weighing: Body weights were taken at the start of the
study and weekly thereafter. Food consumption was determined daily by weighing the containers (after filling and before filling on the next day at 9 am).
- Necropsy of survivors performed: not specified
- Other examinations performed: body weight, macroscopically observation of the forestomach
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- other: macroscopical observation of changes in tissues of the forestomach; effects observed
- Effect level:
- 3 600 mg/kg bw
- Based on:
- test mat.
- Remarks:
- dose calculated according to EFSA Scientific Commitee (2012), concentration as stated in the publication 4% propionic acid in the diet
- Mortality:
- not observed
- Clinical signs:
- other: other: not observed
- Gross pathology:
- When pelleted diet was used, no
hyperplasias were observed. Macroscopical and
histopathological examinations showed no changes in various parts of the gastric mucosa; this could be attributed to the administration of PA in pelleted food for 24 wk. After 12wk of administration, powdered PA produced severe changes in the forestomach but not in the glandular stomach.
Grossly, crater-like growths with marginal hyperplasias and central ulceration were found in the forestomachs of all animals, particularly in the prefundic region (area proximate to the glandular stomach). The limiting ridge was substantially thickened. No histological examinations were made.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The present study was conducted to examine the effects of 0, 4, and 8% propionic acid in the diet of the rats forestomach. Male wistar rats were exposed to feed containing either powdered diet with 4% propionic acid or pelleted feed containing 8% propionic acid. In the group treated with the pelleted feed no hyperplasias were observed whereas in the group fed with powdered diet hyperplasias occurred. No other signs of toxicity were reported, thus, the dose at which the first adverse effect was observed (i.e. changes in the forestomach tissues) was 3600 mg/kg bw. after 12 weeks repeated exposure.
- Executive summary:
The study of Bueld and Netter (1992) was conducted to examine the effects of 0, 4, and 8% propionic acid in the diet to the rats forestomach. Groups of 6 male Wistar rats weighing approximately 130g were exposed to feed containing pelleted diet with 0 or 8% propionic acid for 24 weeks. In a second experiment six male Wistar rats each group were fed powdered diet containing 4% propionic acid for 12 weeks. In the group treated with the pelleted feed no hyperplasias were observed whereas in the group fed with powdered diet hyperplasias occurred. No other signs of toxicity were reported, thus, the dose at which the first adverse effect was observed (i.e. changes in the forestomach tissues) was 3600 mg/kg bw after 12 weeks repeated exposure. Based on the determined value propionic acid does not need to be classified with regard to acute oral toxicity according to Regulation (EU) No. 1272/2008 (CLP) under the conditions of the test.
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