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EC number: 204-638-2 | CAS number: 123-62-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (without detailed documentation; raw data partly incomplete, prior to GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- (documentation deficiencies)
- Principles of method if other than guideline:
- Groups of male and female rats were fed a diet containing the test substance in graduated doses on daily basis for a period of 90 days. During the period of administration the animals are observed closely for signs of toxicity. Animals which die or are killed during the test are subjected to necropsy and, at the conclusion of the test, necropsy is also performed on surviving animals.
- GLP compliance:
- 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:
- propanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Propionsaeure techn.
- Analytical purity: 100 % (acidimetric analysis)
- Stability in feed: up to 3 weeks
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Gassner, Ottobrun
- Age at study initiation: no data
- Weight at study initiation: ♂ approx 135-136g, ♀ approx. 128-129g
- Fasting period before study: no data
- Housing: no data
- Diet: ad libitum
- Water: no data on drinking water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): every three weeks
- Mixing appropriate amounts with (type of food): pulverised Altromin-R (Altrogge, Lage/L)
- Storage temperature of food: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
6200, 12500, 25000, 50000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- - Control: 20 (main study) + 10 (recovery group)
- 6200 ppm: 20 (main study) + 10 (recovery group)
- 12500 ppm: 20
- 25000 ppm 20
- 50000 ppm: 20 (main study) + 10 (recovery group) - Control animals:
- yes, plain diet
- Details on study design:
- POST EXPOSURE PERIOD
- Post-exposure recovery period: 42 days
- Doses: control, 6200 and 50000 ppm
- Number of animals: 10/sex/dose
- Rationale for selecting satellite groups: determining reversibility of effects
DOSE SELECTION RATIONAL: no data
RATIONAL FOR ANIMAL ASSIGNMENT: no data
Examinations
- Observations and examinations performed and frequency:
-
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: no data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: no data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 19-21 days and then 75-78 days after start of feeding
- Anaesthetic used for blood collection: No data
- Animals fasted: yes
- How many animals: 10/sex/time point
- Parameters checked: Leukocytes, erythrocytes, haemoglobin, hematocrit, BUN, differential blood count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 19-21 days and then 75-78 days after start of feeding
- Animals fasted: yes
- How many animals: 10/sex/time point
- Parameters checked: glutamat-pyruvate transaminase
URINALYSIS: Yes
- Time schedule for collection of urine: 14-17 days and then 70-73 days after start of feeding
- Metabolism cages used for collection of urine: No data
- Animals fasted: yes
- How many animals: 10/sex/time point
- Parameters checked: pH, protein, glucose, sediment, sugar - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Parameters examined: weight of the liver, kidneys and heart, testes and spleen. Organ weights in relation to the bodyweights and heart was computed and documented
HISTOPATHOLOGY: Yes
- Organs prepared: CNS (cerebrum and cerebellum), heart, lungs, thyroid, liver , kidneys, adrenals, spleen, stomach, intestines, lymph node of the stomach, genitals and bladder
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS
- During the entire study period, none of the animals showed signs that were related to the administration of the test substance.
MORTALITY: no data
BODY WEIGHT AND WEIGHT GAIN
Mild body weight loss was noticed in the male animals of the 12500 and 25000 ppm dose groups compared to controls. Males of the highest dose group (50000 ppm) experienced weight loss of a prolonged nature starting from the beginning of feeding and lasting till the end of the feeding period. Weight gain of animals fed with diets containing 12500, 25000 and 50000 ppm propionic acid was minimally reduced compared to control animals. In the recovery period, body weights of male and female rats fed a diet containing 50000 ppm propionic acid and female rats which had a diet containing 6200 ppm propionic acid did not quite attain the end body weight of the control animals
FOOD CONSUMPTION
Food consumption in all but the highest dose group (50000 ppm) was comparable to that of the animals in the control group. In the animals of the recovery group (50000 ppm), food consumption was comparable between males and females.
COMPOUND INTAKE (if feeding study): no data
HAEMATOLOGY and CLINICAL CHEMISTRY
- The haematological and clinical chemistry parameters of the treated animals were within physiological limits and comparable to that of the control animals.
URINALYSIS: no data
ORGAN WEIGHTS
- Absolute liver, kidney and heart weights of treated animals were comparable at all doses to that of control animals. In animals of the recovery groups, the absolute liver, kidney and heart weights were comparable between the treated animals and the control animals. Relative kidney to body weight of male animals in the highest dose group was slightly reduced compared to controls. In contrast, for females, the mean relative kidney to body weights was increased in all dose groups compared to control animals. The mean relative heart and liver to body weights were increased in the highest dose group only. This increase was no longer evident in animals of the recovery group. Liver and kidney weights of treated animals expressed relative to the corresponding heart weights were comparable at all doses (including the recovery groups) to that of the corresponding control animals.
GROSS PATHOLOGY
- No test substance dependent macroscopic changes were noticed in any of the treated groups
HISTOPATHOLOGY: NON-NEOPLASTIC
- A dose dependent increase in the incidence and severity of proliferation-acanthosis and retention-hyperkeratosis of the forestomach mucosa was seen from the 12500 ppm dose group and above. These effects were more distinctive in females than in males. Reversibility of these effects was noticed after the 42 day post-exposure-observation-period.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- (local effects; 90 days)
- Effect level:
- 6 200 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- other: Based on the dose dependent increase in the incidence and severity of proliferation-acanthosis and retention-hyperkeratosis of the forestomach mucosa seen from the 12500 ppm dose group and above.
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic effects; 90 days)
- Effect level:
- 50 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.