Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-176-3 | CAS number: 79-09-4
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 73 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 35
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 566 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No experimental data on repeated exposure by inhalation available. Recommended approach using oral data for route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default factor for allometric scaling (dog to human) is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor "worker".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 31 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 62 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 35
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 733 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Recommended approach using oral data and assuming the same absorption for dermal and oral route.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default factor for allometric scaling (dog to human) is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor "worker".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Propionic acid is a short chain carboxylic acid exhibiting corrosive properties. It has a sour, disagreeable odor and a low odor threshold. The most prominent toxic effect after short or long term exposure is local irritation. Propionic acid is found naturally in humans as a normal intermediary metabolite that represents up to 4% of the normal total plasma fatty acids. It is formed as a result of catabolism of amino acids, as a terminal 3-carbon fragment in the oxidation of longer-chained fatty acids, and from the oxidation of the side chain of cholesterol. Propionic acid occurs naturally in foods, and together with other short-chain fatty acids, is ubiquitous in the gastrointestinal tract of humans and other mammals as end-products of microbial digestion. [OECD SIDS, 2007]
In an evaluation by the Joint FAO/WHO Expert Committee on Food Additives which was reaffirmed in 1997, the acceptable daily intake (ADI) of propionic acid and its sodium and calcium salts was designated as “not limited.” A similar conclusion was reached by the USEPA (2003) when it proposed to establish an exemption from the requirement of a tolerance limit for residues of propionic acid and its sodium salts. In the United States, propionic acid is a material generally regarded as safe (GRAS) by the Food and Drug Administration (FDA) for direct addition to human food when used as an anti-microbial agent or as a flavoring agent [21 CFR 184.1081].
Long-term exposure – systemic effects
Inhalation exposure – calculation of the NOAECcorr:
In order to derive the worker DNEL long-term for inhalation route systemic, the NOAEL of 733 mg/kg bw/day from the subchronic oral toxicity study (BASF, 1988) is considered to represent the appropriate dose descriptor for systemic effects related to long-term inhalation exposure.
In order to derive a worker DNEL and under the assumption of a daily exposure period of 8 hours, the oral NOAEL is converted into an inhalation NOAECcorr according to the following formula:
inhalation NOAECcorr
= oral NOAEL × ABSoral(dog)/ABSinhalation(human) × bw(human) / wRV(human)
= 733 mg/kg bw/d × 0.5 × 70 kg / 10 m³ = 2566 mg/m³
with:
oral NOAEL: 733 mg/kg bw/day
ABSoral(dog)/ABSinhalation(human): 0.5 [ratio of oral absorption in the dog to inhalative absorption in the human]
bw(human): standard human body weight (70 kg)
wRV(human): 10 m³ (8 hours) [worker respiratory volume]
Accordingly, the oral NOAEL of 733 mg/kg bw/day is transformed in an inhalation NOAECcorr of 2566 mg/m³.
This NOAECcorr serves as dose descriptor starting point to derive the corresponding DNEL value.
Dermal exposure - calculation of the NOAELcorr:
In order to derive a worker DNEL, the oral NOAEL of 733 mg/kg bw/day (BASF, 1988) is converted into a dermal NOAEL according to the following formula:
dermal NOAEL
= oral NOAEL × ABSoral(rat) / ABSdermal(human)
= 733 mg/kg bw/d × 1
= 733 mg/kg bw/d
with:
oral NOAEL: 733 mg/kg bw/day
ABSoral(rat)/ABSdermal(human): 1 [ratio of oral absorption in the dog to dermal absorption in the human]
Accordingly, the oral NOAEL of 733 mg/kg bw/day is transformed in a dermal NOAEL of 733 mg/kg bw/day. This NOAELcorr serves as dose descriptor starting point to derive the corresponding DNEL value.
Long- and short-term exposure – local effects
Propionic acid is a local irritant. The irritative effects of the substance are thus the most important end point. Identical occupational exposure levels based on local irritation have been published by SCOEL (1993) and MAK (2010) which covers also systemic effects. The 8 -hour TWA of 10 ppm (31 mg/m3) and STEL of 20 ppm (62 mg/m3) were justified by MAK commission as follows (for further details see corresponding MAK document, chapter 13 of IUCLID):
The lateralization threshold (van Thriel et al. 2006) and the results of the study of Walker et al. (2001) show that at concentrations around 40 ml/m3 trigeminally- mediated effects in the respiratory tract are to be expected. The physiological indicators of trigeminally-mediated irritation (nasal airway resistance, blinking frequency, neurogenic inflammation markers) used in the study with test persons (HVBG 2007) did not reveal any significant changes up to the highest exposure concentration of 10 ml/m3. Unlike in the workplace-relevant studies with acetic acid, slight eye irritation was reported after exposure to propionic acid concentrations of 10 ml/m3. As these effects, like the olfactory impressions, decreased over the 4-hour exposure period, it seems unlikely that they were trigeminally mediated, as a summation of the effects over time should be apparent. As the blinking frequency was unchanged, it can be assumed that the NOAEL for objective local effects is above 10 ml/m3. The reported odour nuisance was quantitatively slight, typical adaptation effects were observed and the annoyance did not lead to interference with cognitive performance. Even at concentrations of 10 ml/ m3, unreasonable annoyance as defined by the MAK value is not, therefore, evident. A MAK value of 10 ml/m3 has therefore been established for propionic acid.
As the physiological indicators did not provide any evidence of irritative effects at 10 ml/m3 and the eye irritation was subjectively felt to be very slight, an excursion factor of 2 has been set for short term peak exposures (20 ml/m3).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 70
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 283 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No experimental data on repeated exposure by inhalation available. Recommended approach using oral data for route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default factor for allometric scaling (dog to human) is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor "general population".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.7 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30.8 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 733 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Recommended approach using oral data and assuming the same absorption for dermal and oral route.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default factor for allometric scaling (dog to human) is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor "general population".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 733 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral repeated dose toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default factor for allometric scaling (dog to human) is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor "general population".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Propionic acid is a short chain carboxylic acid exhibiting corrosive properties. It has a sour, disagreeable odor and a low odor threshold. The most prominent toxic effect after short or long term exposure is local irritation. Propionic acid is found naturally in humans as a normal intermediary metabolite that represents up to 4% of the normal total plasma fatty acids. It is formed as a result of catabolism of amino acids, as a terminal 3-carbon fragment in the oxidation of longer-chained fatty acids, and from the oxidation of the side chain of cholesterol. Propionic acid occurs naturally in foods, and together with other short-chain fatty acids, is ubiquitous in the gastrointestinal tract of humans and other mammals as end-products of microbial digestion. [OECD SIDS, 2007]
In an evaluation by the Joint FAO/WHO Expert Committee on Food Additives which was reaffirmed in 1997, the acceptable daily intake (ADI) of propionic acid and its sodium and calcium salts was designated as “not limited.” A similar conclusion was reached by the USEPA (2003) when it proposed to establish an exemption from the requirement of a tolerance limit for residues of propionic acid and its sodium salts. In the United States, propionic acid is a material generally regarded as safe (GRAS) by the Food and Drug Administration (FDA) for direct addition to human food when used as an anti-microbial agent or as a flavoring agent [21 CFR 184.1081].
Long-term exposure – systemic effects
Inhalation exposure – calculation of the NOAECcorr:
In order to derive the general population inhalative long-term DNEL for systemic effects, the NOAEL of 733 mg/kg bw/day from the subchronic oral toxicity study (BASF, 1988) is considered to represent the appropriate dose descriptor.
In order to derive a consumer DNEL and under the assumption of a daily exposure period of 24 hours, the oral NOAEL is converted into an inhalation NOAECcorr according to the following formula:
inhalation NOAECcorr
= oral NOAEL × ABSoral(dog)/ABSinhalation(human) × bw(human) / sRV(human)
= 733 mg/kg bw/d × 0.5 × 70 kg / 20 m³ = 1283 mg/m³
with:
oral NOAEL: 733 mg/kg bw/day
ABSoral(dog)/ABSinhalation(human): 0.5 [ratio of oral absorption in the dog to inhalative absorption in the human]
bw(human): standard human body weight (70 kg)
sRV(human): 20 m³ (24 hours) [consumer respiratory volume]
Accordingly, the oral NOAEL of 733 mg/kg bw/day is transformed in an inhalation NOAECcorr of 1283 mg/m³.
This NOAECcorr serves as dose descriptor starting point to derive the corresponding DNEL value.
Dermal exposure - calculation of the NOAELcorr:
In order to derive a consumer DNEL, the oral NOAEL of 733 mg/kg bw/day (BASF, 1988) is converted into a dermal NOAEL according to the following formula:
dermal NOAEL
= oral NOAEL × ABSoral(rat) / ABSdermal(human)
= 733 mg/kg bw/d × 1
= 733 mg/kg bw/d
with:
oral NOAEL: 733 mg/kg bw/day
ABSoral(rat)/ABSdermal(human): 1 [ratio of oral absorption in the dog to dermal absorption in the human]
Accordingly, the oral NOAEL of 733 mg/kg bw/day is transformed in a dermal NOAEL of 733 mg/kg bw/day. This NOAELcorr serves as dose descriptor starting point to derive the corresponding DNEL value.
Oral exposure:
In an evaluation by the Joint FAO/WHO Expert Committee on Food Additives which was reaffirmed in 1997, the acceptable daily intake (ADI) of propionic acid and its sodium and calcium salts was designated as “not limited.” A similar conclusion was reached by the USEPA (2003) when it proposed to establish an exemption from the requirement of a tolerance limit for residues of propionic acid and its sodium salts. In the United States, propionic acid is a material generally regarded as safe (GRAS) by the Food and Drug Administration (FDA) for direct addition to human food when used as an anti-microbial agent or as a flavoring agent [21 CFR 184.1081].
An oral consumer DNEL for systemic effects was derived from the oral NOAEL of 733 mg/kg bw/day (BASF, 1988).
Long- and short-term exposure – local effects
Propionic acid is a local irritant. The irritative effects of the substance are thus the most important end point. Identical occupational exposure levels based on local irritation have been published by SCOEL (1993) and MAK (2010) which covers also systemic effects. The 8 -hour TWA of 10 ppm (31 mg/m3) and STEL of 20 ppm (62 mg/m3) were justified by MAK commission as follows (for further details see corresponding MAK document, chapter 13 of IUCLID):
The lateralization threshold (van Thriel et al. 2006) and the results of the study of Walker et al. (2001) show that at concentrations around 40 ml/m3trigeminally- mediated effects in the respiratory tract are to be expected. The physiological indicators of trigeminally-mediated irritation (nasal airway resistance, blinking frequency, neurogenic inflammation markers) used in the study with test persons (HVBG 2007) did not reveal any significant changes up to the highest exposure concentration of 10 ml/m3. Unlike in the workplace-relevant studies with acetic acid, slight eye irritation was reported after exposure to propionic acid concentrations of 10 ml/m3. As these effects, like the olfactory impressions, decreased over the 4-hour exposure period, it seems unlikely that they were trigeminally mediated, as a summation of the effects over time should be apparent. As the blinking frequency was unchanged, it can be assumed that the NOAEL for objective local effects is above 10 ml/m3. The reported odour nuisance was quantitatively slight, typical adaptation effects were observed and the annoyance did not lead to interference with cognitive performance. Even at concentrations of 10 ml/ m3, unreasonable annoyance as defined by the MAK value is not, therefore, evident. A MAK value of 10 ml/m3has therefore been established for propionic acid.
As the physiological indicators did not provide any evidence of irritative effects at 10 ml/m3and the eye irritation was subjectively felt to be very slight, an excursion factor of 2 has been set for short-term peak exposures (20 ml/m3).
The values are regarded to be safe for workers; according to the ECHA Guidance document the intraspecies factor is by a factor of 2 higher for general population than for worker. Also the possible exposure time may be by a factor 3 (8 hrs. vs. 24 hrs) and by a factor 1.4 (5 days/week vs. 7 days/week) longer. Therefore, an additional AF of 8.4 is added to the OEL value, resulting in a long-term DNEL for general population of 1.2 ppm ( 3.7 mg/m3). For short-term peak exposure, an additional AF of 2 is considered, resulting in a DNEL of 10 ppm (30.8 mg/m3).
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.