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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
Calcium dipropionate does not show signs of dermal sensitisation, and the two constituents calcium and propionic acid also have not shown any skin sensitisation potential in experimental testing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions (no positive contrtol group, lesser animals (test group), lesser application volume during induction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no positive control group, lesser animals (test group), lesser application volume during induction)
- Principles of method if other than guideline:
- Method: other: according to the method described by Magnusson and Kligmann "Allergie contact dermatitis in the guinea pig" Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not applicable.
- Species:
- guinea pig
- Strain:
- other: albino SPF guinea pigs
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Age at study initiation: young
- Sex: male
- Weight at study initiation: 200-300g
- Housing: in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: ad libitum; stock diet enriched with vitamin C
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 10
- Humidity (%): 45 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Induction: water and vaseline for intradermal and topical induction, respectively. Challenge: vaseline
- Concentration / amount:
- Induction: 2% (intradermal), 20% (topical)
challenge: 20% (topical) - Route:
- epicutaneous, open
- Vehicle:
- other: Induction: water and vaseline for intradermal and topical induction, respectively. Challenge: vaseline
- Concentration / amount:
- Induction: 2% (intradermal), 20% (topical)
challenge: 20% (topical) - No. of animals per dose:
- Control: 10
treated animals: 6 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection:
- Site: shoulder
- Concentration: 2% (0.05 ml/site) (lowest irritating concentration)
- Vehicle: distilled water
- Test group 1: Freund's complete adjuvant (FCA)
- Test group 2: The test article in distilled water
- Test group 3: Freund's complete adjuvant and test article in distilled water (1:1)
- Control group 1: Freund's complete adjuvant (FCA) 1:1 with physiological saline(0.9%).
- Control group 2: Distilled water
- Control group 3: Freund's complete adjuvant and distilled water (1:1)
- Frequency of applications: 1x, 2 injections/dose
- Evaluation (hr after injection): no data
Topical Induction Exposure:
- Time Schedule: about 1 week after intradermal injections
- Concentration: 20% in vaseline
- Route of exposure: epicuteneous, patches of whatman filter paper (2 x 4 cm) saturated with the test substance
- Type of coverage: occlusive
- Duration: 48h.
- Evaluation (hr after injection): no data
B. CHALLENGE EXPOSURE
1st Challenge: Test groups and control group treated identically in the following manner
- Day(s) of challenge: 2 weeks after topical induction exposure
- Route of exposure: epicutaneous, applied to an area of about 2 x 2cm; A small amount of the mixture was applied to the shaved area of each animal and gently massaged in with a glass rod for about 30 seconds
- Exposure period: 24 h
- Concentration: 20%,
- Vehicle: vaseline
- Evaluation (hr after challenge): 24h, scoring of findings using Draize score system for scoring skin irritation - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs occured
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs occurred.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical signs occured
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in vaseline. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No clinical signs occurred.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not specified
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- not specified
- Remarks on result:
- other: not specified
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions (no positive control group, lesser animals(test group), lesser application volume during induction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no positive control group, lesser animals (test group), lesser application volume during induction)
- Principles of method if other than guideline:
- Method: other: according to the method described by Magnusson and Kligmann "Allergie contact dermatitis in the guinea pig" Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not applicable.
- Species:
- guinea pig
- Strain:
- other: albino SPF guinea pigs
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Age at study initiation: young
- Sex: male
- Weight at study initiation: 200-300g
- Housing: in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: ad libitum; stock diet enriched with vitamin C
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 10
- Humidity (%): 45 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Induction: water and vaseline for intradermal and topical induction, respectively. Challenge: vaseline
- Concentration / amount:
- Induction: 2% (intradermal), 20% (topical)
challenge: 20% (topical) - Route:
- epicutaneous, open
- Vehicle:
- other: Induction: water and vaseline for intradermal and topical induction, respectively. Challenge: vaseline
- Concentration / amount:
- Induction: 2% (intradermal), 20% (topical)
challenge: 20% (topical) - No. of animals per dose:
- Control: 10
treated animals: 6 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection:
- Site: shoulder
- Concentration: 2% (0.05 ml/site) (lowest irritating concentration)
- Vehicle: distilled water
- Test group 1: Freund's complete adjuvant (FCA)
- Test group 2: The test article in distilled water
- Test group 3: Freund's complete adjuvant and test article in distilled water (1:1)
- Control group 1: Freund's complete adjuvant (FCA) 1:1 with physiological saline (0.9%).
- Control group 2: Distilled water
- Control group 3: Freund's complete adjuvant and distilled water (1:1)
- Frequency of applications: 1x, 2 injections/ dose
- Evaluation (hr after injection): no data
Topical Induction Exposure:
- Time Schedule: about 1 week after intradermal injections
- Concentration: 20% in vaseline
- Route of exposure: epicuteneous, patches of whatman filter paper (2 x 4 cm) saturated with the test substance
- Type of coverage: occlusive
- Duration: 48h.
- Evaluation (hr after injection): no data
B. CHALLENGE EXPOSURE
1st Challenge: Test groups and control group treated identically in the following manner
- Day(s) of challenge: 2 weeks after topical induction exposure
- Route of exposure: epicutaneous, applied to an area of about 2 x 2cm; A small amount of the mixture was applied to the shaved area of each animal and gently massaged in with a glass rod for about 30 seconds
- Exposure period: 24 h
- Concentration: 20%,
- Vehicle: vaseline
- Evaluation (hr after challenge): 24h, scoring of findings using Draize score system for scoring skin irritation - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs occurred
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs occurred.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical signs occurred
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in vaseline. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No clinical signs occurred.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not specified.
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- not specified
- Remarks on result:
- other: not specified
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Referenceopen allclose all
- All animals remained in good health during the experiment and gained weight.
INDUCTION
- Intradermal
The intra-dermal injections of each of the three test substances given in the induction phase of the study resulted in the following reactions:
1. Freund's Complete Adjuvant: erythema: 2, edema: 2
2. 2 % Luprosil in water: greyish discolouration (diameter 6 mm)
3. 2% Luprosil in Adjuvant and water (1 :1) : erythema, edema.
- Topical
The topical application of the test substances in a 20% mixture with vaseline during the induction period did not result in erythema or edema or produced only very slight erythema
CHALLENGE
The challenge dose of the test substances provoked neither erythema nor edema in the test animals and in the controls.
From these results it is concluded that under the conditions of' this experiment the Luprosil salt (78/28) did not induce sensitization
- All animals remained in good health during the experiment and gained weight.
INDUCTION
- Intradermal
The intra-dermal injections of each of the three test substances given in the induction phase of the study resulted in the following reactions:
1. Freund's Complete Adjuvant: erythema: 2, edema: 2
2. 2 % Luprosil in water: greyish discolouration (diameter 6 mm)
3. 2% Luprosil in Adjuvant and water (1 :1) : erythema, edema.
- Topical
The topical application of the test substances in a 20% mixture with vaseline during the induction period did not result in erythema or oedema or produced only very slight erythema
CHALLENGE
The challenge dose of the test substances provoked neither erythema nor oedema in the test animals and in the controls.
From these results it is concluded that under the conditions of' this experiment the Luprosil salt (78/28) did not induce sensitization
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Read-across approach
Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the metal cation and the organic acid anion. This way forward is acceptable, since metal carboxylates are shown to dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility and dissociation tests (please refer to the water solubility and dissociation in sections 4.8 and 4.21 of IUCLID). Once the individual transformation products of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by a combination of the toxicity of these transformation products, i.e. the metal cation and carboxylate anion according to an additivity approach.
Calcium dipropionate is the calcium salt of propionic acid, which readily dissociates to the corresponding divalent calcium cation and monovalent propionate anions. The calcium cation and the propionate anion are considered to represent the overall toxicity of calcium dipropionate in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts).
A detailed justification for the read-across approach is added as a separate document in section 13 of IUCLID.
Sensitisation
Information on skin sensitisation with calcium dipropionate is available. In addition, the skin sensitisation potential will be addressed with existing data on the dissociation products as detailed in the table below. Further details on the skin sensitisation potential of the individual constituents within the framework of regulation (EC) 1907/2006 are given below.
Table: Summary of skin sensitisation data of calcium dipropionate and the individual constituents.
calcium substances
propionic acid
(CAS# 79-09-4)
Calcium dipropionate
(CAS# 4075-81-4)
Skin sensitisation
not sensitising
not sensitising
not sensitising Calcium dipropionate did not show signs of dermal sensitisation, and the two constituents calcium and propionic acid also have not shown any skin sensitisation potential in experimental testing. Thus, Calcium dipropionate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
According to the CLP regulation the hazard identification and subsequently a proposal for classification as “Respiratory sensitiser” will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated.
The evidence could be:
- clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include:
- in vivo immunological test (e.g. skin prick test);
- in vitro immunological test (e.g. serological analysis);
- studies that indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated low-level irritation, pharmacologically mediated effects;
- a chemical structure related to substances known to cause respiratory hypersensitivity
- data from one or more positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction.
Calcium dipropionate is not expected to show a respiratory sensitising potential.
- clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include:
Justification for classification or non-classification
Calcium dipropionate does not show signs of dermal sensitisation, and the two constituents calcium and propionic acid also have not shown any skin sensitisation potential in experimental testing. Thus, Calcium dipropionate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.
In long-time industrial experience in the production and handling of substance calcium dipropionate, no cases of respiratory hypersensitivity have been observed. Classification as respiratory sensitiser is not applicable.
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.