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EC number: 223-795-8 | CAS number: 4075-81-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 December 2021 - 31 December 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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
- Test material form:
- solid: particulate/powder
- Remarks:
- white powder
- Details on test material:
- Name: Calcium dipropionate
Chemical name: calcium dipropionate
Supplier: DURA EUROPE, S.A.U.
CAS Number: 4075-81-4
Batch/Lot number: LM6/078
Appearance: white powder
Purity: 99.9%
Ca content: 21.24%
Expiry date: 10 November 2026
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Han:WIST rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt., H-1122 Budapest, Magyar Jakobinusok tere 4B
- Hygienic level at supplier: SPF
- Hygienic level during the study: Standard housing conditions
- Number of animals: 6 animals, 3 animals/group
- Sex: Female, nulliparous and non-pregnant animals
- Age of animals at dosing: Young adult rats, approx. 8-9 weeks old
- Body weight range at dosing: 175-185 g. The maximum difference of individual animal weights from the mean of the treatment group did not exceed 20%.
- Acclimatisation period: At least 8 days
- Animal health: Only healthy animals were used for the test. The health status was certified by the Veterinarian.
- Housing: Group caging (3 animals/cage)
- Cage type: T3H polycarbonate
- Bedding and nesting: “SAFE 3/4-S-FASERN” certified wooden chips and “Sizzle pet” nest material were available to animals during the study.
- Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Animals received standard laboratory rat diet, ad libitum, and tap water from the municipal supply, as for human consumption from drinking bottles designed for rodents, ad libitum.
- The night before treatment, the animals were fasted. Food, but not water, was withheld overnight. Animals were weighed before dosing. Food was replaced 3 hours after the treatment.
ENVIRONMENTAL CONDITIONS
- Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
- Temperature: 21 – 23 °C (target: 22 ± 3 °C)
- Relative humidity: 36 – 58 % (target: 30 – 70 %)
- Ventilation: 15-20 air exchanges/hour
IN-LIFE DATES: From 16 December 2021 to 31 December 2021
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The test item dissolved in distilled water,
thus distilled water was chosen as vehicle for this study.
- Lot/batch no.: 2108-5518
- Manufacturer: Parma Produkt Kft.
- Expiry date: 18 February 2022
DOSAGE PREPARATION: The test item was freshly formulated in the vehicle at the appropriate concentration (200 mg/mL), in the Pharmacy of NEXTREAT Laboratories on the day of administration. The formulations were stirred with magnetic stirrer up to finishing the treatment.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As starting dose level for acute toxicity study, a dose of 2000 mg/kg body weight (bw) has been selected based on the information published by ECHA.
- Initially three animals were treated at the starting dose of 2000 mg/kg bw (Group 1). All three animals survived, temporarily showing clinical signs, thus the second group (Group 2) was treated at the same dose level (2000 mg/kg bw). In the second group, two animals behaved similarly to those in the first group, but as one animal showed severe clinical symptoms, after consultation with the Veterinarian it was decided to pre-terminally euthanize it. As per the guideline, this is considered in the interpretation of the test results in the same way as animals that died on test. As no further mortality was observed in this confirmatory dose group, no additional testing was required according to the criteria for termination given in Annex 2d of OECD Guideline No. 423. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 animals per group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: Following the end of the dosage, the animals were observed individually once during the first 30 minutes, at 1, 2, 3, 4 and 6 hours after the treatment and once daily for 14 consecutive days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The time of death was recorded as precisely as possible.
- Body weight: The body weight of the animals was recorded on Days 0 (prior to dosing), 7 and 14 (prior to necropsy), with a precision of 1 g.
- Necropsy: Animals were subjected to a necropsy and a macroscopic examination. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross macroscopic changes were recorded for each animal. - Statistics:
- The method used was not intended to allow the calculation of a precise LD50 value.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose level of 2000 mg/kg bw, 1/6 animals was euthanized pre-terminally because of animal welfare reasons on Day 0. The other animals (5/6) survived.
- Clinical signs:
- other:
- Body weight:
- lower than 10% body weight loss
- Remarks:
- There were no effects on body weight or body weight gain that could be attributed to treatment with the test item.
- Gross pathology:
- In the pre-terminally euthanized animal, diffuse, dark red discoloration of the glandular
mucosa of the stomach was observed. There were no other macroscopic changes seen at the necropsy of the other animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- The test substance is not classified according to Regulation (EC) No 1272/2008 (CLP)
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Calcium dipropionate was found to be above 2000 mg/kg bw in female Han:WIST rats.
The LD50 cut-off value is 2500 mg/kg bw.
The study result triggers the following classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): Unclassified
- GHS (rev. 7) 2017: Category 5
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