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EC number: 204-638-2
CAS number: 123-62-6
Due to the very short half-life (4 minutes) in aqueous media, propionic
acid is a valid read-across substance for propionic anhydride, as it is
the primary hydrolysis product.
There are no reproductive toxicity studies available for n-propionic
acid. Data from a 100 days repeated-dose study in dogs did not result in
toxicity to reproductive organs.
In a dog study satisfying GLP requirements and OECD 409 TG, propionic
acid (> 99% purity) was administered via diet to male and female Beagle
dogs (4/sex/dose) for approximately 100 days at diet concentrations
of 0, 3000, 10000 and 30000 ppm propionic acid. A recovery period of 6
weeks was allocated for the groups (4/sex/dose) receiving 0 and 3000 ppm
propionic acid in the diet. No mortality occurred during the
administration period. No substance related clinical signs of toxicity
occurred. Calculated from food consumption, the mean daily dose
administered were 214.2, 718.9, 2056.3 mg/kg bw for males and 225.1,
749.2, 2071.8 mg/kg bw for females. Dogs from the high-dose group
displayed a decrease in appetite, which was attributed as a response due
to unpalatability of the diet. This decrease in food consumption however
did not seem to significantly affect body weights or body weight gains.
No systemic effects were observed even at the highest dose. There were
no significant changes in haematology, urinalysis, or clinical chemistry
parameters that could be attributed to the test material. Necropsy of
dogs after the administration interval revealed no gross lesions.
Examination of tissues revealed no lesions except point-of-contact
diffuse epithelial hyperplasia of the mucosa of the oesophagus in
several high dose dogs. This effect was reversible after a 6 week
recovery period. The incidence of focal epithelial hyperplasia in lower
dose animals was comparable to controls. There were no effects observed
on male or female reproductive organs. The NOAEL for this study for
systemic /reproductive organ effects is 3000 ppm propionic acid in the
diet or 2056,3 mg/kg bw for male dogs and 2071.8 mg/kg bw for female
dogs (BASF, 1988).
Read across to calcium propionate (CAS No.4075-81-4) - Rat: NOAEL (maternal toxicity): 300 mg/kg bw; NOAEL (developmental toxicity): 300 mg/kg bw- Mouse: NOAEL (maternal toxicity): 300 mg/kg bw; NOAEL (developmental toxicity): 300 mg/kg bw- Rabbit: NOAEL (maternal toxicity): 400 mg/kg bw; NOAEL (developmental toxicity): 400 mg/kg bw- Hamster: NOAEL (maternal toxicity): 400 mg/kg bw; NOAEL (developmental toxicity): 400 mg/kg bw
There are no data available for n-propionic acid. Calcium
propionate is an ion pair, which readily dissociates in water. The
dissociation constant shows that at the low pH of the stomach, the
important moieties from a toxicological standpoint are the unionized
free acid and ionized metal. Because of this, mammalian toxicity data
for calcium propionate can serve as surrogate data for the acid. Data
for calcium propionate in four species (mouse, rat, hamster, and rabbit)
Calcium propionate was fed to pregnant CD-1 mice and Wistar rats during
gestation days 6-15 at dose levels of 3, 14, 65, and 300 mg/kg-bw/day.
Pregnant rabbits and hamsters were fed calcium propionate at a doses of
0, 4, 19, 86, and 400 mg/kg-bw/day during gestation days 6-18 (rabbits)
or 6-10 (hamsters). Body weights of dams were taken at several intervals
during gestation. Dams were observed each day for food and water intake
and other measures of appearance and behavior. Dams were sacrificed on
gestation day 17 (mice), 20 (rats), 14 (hamsters), or 29 (rabbits).
Numbers of implantation sites, resorption sties, and live and dead
fetuses were recorded. Body weights of live pups were also recorded. All
pups were examined grossly for external congenital abnormalities.
One-third of the fetuses of each litter underwent detailed visceral
examinations; two-thirds were examined for skeletal defects. In all
species, there was no effect on maternal or fetal survival, or on fetal
or litter size. No increase in fetal or skeletal abnormalities was
observed. The NOAEL for maternal toxicity and developmental in rats is
300 mg/kg bw. The NOAEL for maternal toxicity and developmental in mouse
is 300 mg/kg bw. The NOAEL for maternal toxicity and developmental in
rabbits is 400 mg/kg bw and the NOAEL for maternal toxicity and
developmental in hamster is 400 mg/kg bw (FDA 1972). The study is
acceptable for asssessment with restrictions. The authors provided no
reason why tests were not performed up to the limit concentration.
However, based on the findings from the repeated dose studies,
forestomach lesions will be expected to occur at the limit dose.
reproduction toxicity is not warranted according to the criteria of EU
Directive 67/548/EEC and EU Classification, Labelling and Packaging of
Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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