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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- (documentation deficiencies)
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium dipropionate
- EC Number:
- 223-795-8
- EC Name:
- Calcium dipropionate
- Cas Number:
- 4075-81-4
- Molecular formula:
- C3H6O2.1/2Ca
- IUPAC Name:
- calcium dipropanoate
- Details on test material:
- Name of test material (as cited in study report): calcium propionate
- Physical state: fine white crystalline
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: adult
- Average body weight at study initiation: 229.5 g
- Fasting period before study: no data
- Housing: individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): tap water, free access
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Animals were housed in temperature and humidity controlled quarters
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: no data
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: no data
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as day 0
- Any other deviations from standard protocol: no - Duration of treatment / exposure:
- days 6-15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
- No. of animals per sex per dose:
- 24 females
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data
- Positive control: Acetylsalicyl acid (ASA) administered at 250 mg/kg bw
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 11, 15 and 17 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Frequency of measurement: daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice: on gestation day 20 by surgical anaesthesia
- Organs examined: no data
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes, the number of live and dead foetuses were recorded
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [one third per litter]
- Skeletal examinations: Yes: [two thirds per litter]
- Head examinations: no
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The administration of up to 300 mg/kg (body weight) of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on on dams.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
TEST SUBSTANCE:
- The administration of up to 300 mg/kg (body weight) of the test material to pregnant rat for 10 consecutive days had no clearly discernible effect on nidation or fetal survival.
- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls
POSITIVE CONTROL (ASA)
- Weight reduction in foetuses of dams treated with 250 mg/kg bw with a reduction of the average weight of about 41.4 compared to controls
- Increased number of total resorptions with a total number of resorptions in the positive control reaching 102 as compared to only 6 in the controls. There was also an increased percentage of partial and complete resorption in comparison to negative control animals. The percentage of partial resorptions in positive control animals was 79.2% compared to only 17.4 in negative control animals. Twenty five percent of the embryos were completed resorbed as compared to 0% in the negative control animals.
- An average of 6.6 fetuses/ dam were alive at necropsy in the positive control group totalling 160 in all. In comparison, 10.6 fetuses/ dam were alive in the negative control group making a total of 243 fetuses
- Skeletal investigations revealed malformations and variations of the sternebrae, ribs, verterbrae, skull and extremities in animals of the positive control group (see attachment). Miscellaneous findings included missing and reduced hyoids
- Soft tissue investigations included exencephaly, spina bifida, enterohepatocele
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
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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