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Diss Factsheets
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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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- 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: see 'Remark'
- Remarks:
- Comparable to guideline study with acceptable restrictions (In order to determine MTD or maximum non irritation dose on the skin, study focused only on point-of-contact changes caused by the test substance. No clinical chemistry, no haematology, limited histopathology, limited gross pathology, no post exposure group)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- (No clinical chemistry, no haematology, limited histopathology, limited gross pathology, no post exposure group, no food consumption determined)
- GLP compliance:
- yes
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
- Analytical purity: greater than or equal to 99.7%
- Test substance number: 85/473-1
- Physical state/colour: liquid/colourless
- Storage: RT
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crl:CD1(ICR)BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Charles River Wiga GmbH, Sulzfeld
- Age at study initiation: 49 days old
- Weight at study initiation: 25.2 - 30.2
- Fasting period before study: no data
- Housing: singly in Type I macrolon cages from BECKER GmbH and Co
- Diet: ad libitum; Kliba Haltungsdiaet Ratte/Maus/Hamster GLP 343 (Klingentak Muehle AG, Switzerland)
- Water: ad libitum (drinking water)
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: no exact data; interscalpular region ~1 cm²
- Time intervals for shavings: test site shaved as required
REMOVAL OF TEST SUBSTANCE: No, after application of the test substamnce, the test substance was spread on the skin using a stab.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 6, 8, 10 % in aqua bidest. After 3 weeks, the 6% propionic in water was replaced by 14% propionic acid in water
- Constant volume used: yes
USE OF RESTRAINERS FOR PREVENTING INGESTION: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- TEST SUBSTANCE
- Rate of preparation of substance preparations (frequency): every 14 days
- Stability: characterized before and at the end of the study
- Stability in vehicle: stable for 20 days in water
- Method of analysis: potentiographic titration - Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 1x/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
136.9, 169.0, 237.4 mg/kg bw (calculated from concentrations and mean bodyweights over the entire study period)
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
8%, 10% and 14% aqueous solution
Basis:
other: concentration
- Remarks:
- Doses / Concentrations:
At the beginning of the study the applied concentrations were 6%, 8% and 10%. When after 3 weeks of treatment no dermal effects occurred the 6% and 8%, the 6% was increased to 14%.
Basis:
- No. of animals per sex per dose:
- 10 female animals
- Control animals:
- yes
- Details on study design:
- - Controls: from a study which was being performed parallel to this study
- Dose selection rationale: based on the results of a preliminary dose range finding study (BASF AG 18C0473/85124) whereby 6% of propionic acid in water caused no effects on skin, 8% exhibited minimal skin irritations and 16% caused skin marked skin changes
- Rationale for animal assignment: random
- Post-exposure recovery satellite groups: No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly
MORTALITY: Yes
- Time schedule: twice daily on work days and once daily over the weekends and on public holidays
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: once weekly
BODY WEIGHT: Yes
- Time schedule for examinations: once weekly
FOOD CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- SACRIFICE:
- Time schedule: moribund animals and at termination
- CO2 asphyxiation
GROSS PATHOLOGY AND HISTOPATHOLOGY: Yes
- Only skin was examined
Results and discussion
Results of examinations
- Details on results:
- MORTALITY
No mortality occurred over the entire study period.
BODY WEIGHT AND WEIGHT GAIN
Body weights were comparable throughout the study between all test groups and the control groups:
Mean body weights after 98 days
- control 29.79 g
- 8%: 29.2 g
- 10%: 29.58 g
- 14%: 29.49 g
CLINICAL SIGNS/GROSS PATHOLOGY
- 8% propionic acid: no skin changes were observed over the entire dosing period of 90 days
- 10% propionic acid: totally, the skin of 6/10 animals was affected whereby following was observed: skin crusts in 2 animals, scad in one animal, scales in 2 animals.
- 14% propionic acid: the skin of all 10 animals were affected: formation of crustaceous skin tissue (1/10 animals), skin defects (3/10 animals), scab formation (5/10 animals), erythema (1/10 animals)
HISTOPATHOLOGY
- 8% propionic acid: 3/10 animals displayed acanthosis and fibrous condensation with inflammation of corium connective tissue usually accompanied by the skin loosing its ability to fold normally and 2/10 animals displayed crustaceous tissue and ulceration of the skin. The maximum non-irritant dose lies below 8 %.
10% propionic acid: 6/10 animals showed skin lesions from erythema and crust formation to ulceration which were in general less pronounced than in the high concentration. This was affirmed pathologically and histology revealed acanthosis and fibrous condensation with inflammation of corium connective tissue usually accompanied by the by the skin loosing its ability to fold normally.
14%: all animals showed skin lesions ranging from erythema and crust formation to ulceration in 5/10 animals. This was affirmed pathologically and histology revealed acanthosis and fibrous condensation with corium inflammation of connective tissue usually accompanied by the skin loosing its ability to fold normally.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 136.9 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
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.
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