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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62 mg/m³
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62 mg/m³
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
132 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
260 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
15
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

As demonstrated in sections 5 and 7, propionic anhydride is hydrolyzed to propionic acid within minutes upon exposure to an aqueous system. Thus, read-across of propionic anhydride to propionic acid is relevant and appropriate. (see hydrolysis testing in section 5, 5.1.2)

 

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 endproducts of microbial digestion (Mellon 2000). Propionic acid occurs physiologically as an intermediate in breakdown of odd-numbered fatty acids, cholesterol and amino acids (valine, isoleucine, norleucin, methionine, and threonine). Up to four percent of volatile fatty acids in blood of humans (0.28-0.32 mmol/l) are propionic acid (Baessler 1959).

Toxicological effects of propionic acid are practically solely due to the caustic properties of the concentrated substance. Therefore only local effects are of relevance for this substance.In view of the negative mutagenicity data, and the production of forestomach papillomas in rats at dosages associated with hyperplasia, propionic acid is not considered to be a carcinogenic risk to humans.Propionic acid is practically of no concern for adverse systemic effects.

 

 

Short term exposure

 

Propionic acid is a natural occurring metabolite in cell metabolism. Toxicological effects of propionic acid are practical solely due to the caustic properties of the concentrated substance. Therefore only local effects are taken into detailed DNEL consideration

 

Inhalation exposure:

The health-based occupational exposure limit (OEL,STEL (15 mins)) of 61 mg/m³ provided in the "Recommendation from the Scientific Committee on Occupational Exposure Limits for Propionic acid 8 79-09-4 (2009)" (SCOEL) is used as DNEL for short-term inhalation exposure, which is the most relevant route of exposure to propionic acid in a workplace situation. STEL value is derived to protect from irritative/caustic effect. Therefore STEL is supposed to protect from any systemic properties via inhalation as well.

As propionic acid is a caustic substance a short term a local DNEL is not quantifiable. Base on current experience with the substance specific concentration limit of 10 % for no classification of propionic acid in the EU is considered as short term dermal DNEL. Never the less, long term dermal DNELs are employed to consider short dermal effects in exposure scenarios (see below).

 

Long term exposure

Inhalation exposure: The health-based occupational exposure limit (OEL, 8-hour TWA) of 31 mg/m³ provided in the "Recommendation from the Scientific Committee on Occupational Exposure Limits for Propionic acid 8 79-09-4 (2009)" (SCOEL) is used as DNEL for long-term inhalation exposure, which is the most relevant route of exposure to propionic acid in a workplace situation.

Propionic acid is a natural occurring metabolite in cell metabolism. Toxicological effects of propionic acid are solely due to the caustic properties of the concentrated substance. STEL value is derived to protect from irritative/caustic effect. Therefore STEL is supposed to protect from any systemic properties as well.

 

Dermal exposure: In the only repeated dose dermal toxicity study available, 50 µl propionic acid (≥ 99.7% pure) in water was applied (open), once a day, 5 days a week for a period of 90 days to the interscapular region (shaved skin) of female Crl:CD1(ICR)BR mice/dose. Dose levels were 0, 8%, 10% and 14% propionic acid.. The calculated amount of propionic acid applied to the skin was 136.9, 169.0, 237.4 mg/kg bw, respectively. The LOAEL (local effects) for this study is 8% or 136.9 mg/kg bw. The NAOEL for systemic effects was >14% or >237.4 mg/kg bw. The study is used only to derive a local dermal DNEL. AsPropionic acid is practically of no concern for adverse systemic effects. Oral 2 year study is used to derive a systemic dermal DNEL as it is the highest long-term systemic DNEL available (see below).

 

Dermal worker long term (local)

Description

Value

Remark

Step 1) Relevant dose-descriptor

LOAELmouse

137 mg/kg bw

LOAEC 8%

NOAEL (90 d, mouse, systemic effects) > 237.4 mg/kg bw

 

NOAEL (90 d, mouse, local effects) = 136.9 mg/kg bw

 

Step 2) modification of the starting point

 

 

 

3

LOAEL to NAEL

Step 3) Assessment factors

 

 

Exposure duration

1

Sub chronic to Chronic (specific time extrapolation of local effects: For local irritation the concentration is in most cases the relevant parameter, and prolongation of exposure is expected to influence the severity of effect and morphology of changes, but not the NOAEC

Interspecies

1

Local effect

Intraspecies

5

worker

Quality of database

1

 

DNEL

Value

For workers (local)

137/ 3 (1 x 1 x 5 x 1) =9.1 mg/kg bw. ~ 260 µg/cm2* ~ 2.5%**

*    inter scalpular region ca. 1 cm²; mea body weight mice in the 90 day study 28.2g at the beginning

**  8% /3 ~ 2.5 %

***speciffic concentration limit of propionic acid: no irritation/corrosion labelling < 10%

 

Systemic

Toxicological effects of propionic acid are practically solely due to the caustic properties of the concentrated substance. Therefore only local effects are of relevance for this substance. Propionic acid is practically of no concern for adverse systemic effects.As systemic NOAEL the highest test concentration in the long-term oral toxicity study is used to derive a systemic long term DNEL. This is a protective systemic DNEL based on the highest repeated dose test concentration availiable.

Dermal worker long term (systemic)

Description

Value

Remark

Step 1) Relevant dose-descriptor

 

NOAEL(rat )

2640 mg/kg bw

 

NOAEL (2 yrs, oral) (carcinogenicity /systemic toxicity): 4000 ppm = 2640 mg/kg bw

 

NOAEL (2 yrs, oral) (local effects): 400 ppm = 264 mg/kg bw 

Griem W. (1985)

 

Step 2) modification of the starting point

 

 

 

1/1

 absorption oral to dermal.

Step 3) Assessment factors

 

 

Exposure duration

1

chronic study

Interspecies

4

 Extrapolation systemic effects rat to human (for systemic effects only)

Intraspecies

5

worker

Quality of database

1

 

DNEL

Value

For workers (systemic)

 2640 mg/kg/day / (1 x 4 x 5 x 1) >132 mg/kg/day bw.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population