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EC number: 228-067-3 | CAS number: 6107-56-8
- 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
The skin sensitisation potential of the test item is read-across from dilithium adipate. The skin sensitisation potential of dilithium adipate was determined in a LLNA study conducted according to OECD 429 and EU Method B.42 guidelines, and dilithium adipate was determined not to be a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 October 2015 to 26 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2, 15 and 30 % test item w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w
SCORE:
Erythema and eschar formation:
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) - 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema - 4 - Positive control substance(s):
- other: no
- Positive control results:
- A reliability check is carried out at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques used at the laboratory. The last check was performed in April 2015. The SI values calculated for the item concentrations 5, 10 and 25% were 1.7, 3.0 and 9.1 respectively. An EC3 value of 10% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%. The results of the 6 monthly HCA reliability checks of the recent years were 16.5, 14.5, 13.4, 14.1, 17.3 and 9.8%. Based on the results, it was concluded that the Local Lymph Node Assay as performed at the laboratory is an appropriate model for testing for contact hypersensitivity.
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Test item concentration = 2%
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Test item concentration = 15%
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- Test item concentration = 30%
- Parameter:
- EC3
- Value:
- > 30
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dilithium adipate would not be regarded as a skin sensitizer.
- Executive summary:
This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 07 October 2015 to 26 October 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Source and target substances are likely to dissociate after administration into metals ions and fatty acids due to the ionic bond between the metal cation and fatty acid ion being disrupted by polar aqueous media. The fatty acid component is not expected to be hazardous as it is potentially exempt from REACH under Annex V. The main difference between source and target substances is the cation and therefore test organisms would be exposed to either calcium from the target substance or lithium from the source substance. Although the cations are different, read across from lithium adipate is considered to be appropriate for in vitro genetic toxicity and skin sensitisation as both lithium and calcium show a similar lack of toxicity for these endpoints. Further information is included in the read-across justification attached to Section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 2, 15 and 30 % test item w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w
SCORE:
Erythema and eschar formation:
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) - 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema - 4 - Positive control substance(s):
- other: No
- Positive control results:
- A reliability check is carried out at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques used at the laboratory. The last check was performed in April 2015. The SI values calculated for the item concentrations 5, 10 and 25% were 1.7, 3.0 and 9.1 respectively. An EC3 value of 10% was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%. The results of the 6 monthly HCA reliability checks of the recent years were 16.5, 14.5, 13.4, 14.1, 17.3 and 9.8%. Based on the results, it was concluded that the Local Lymph Node Assay as performed at the laboratory is an appropriate model for testing for contact hypersensitivity.
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Test item concentration = 2%
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Test item concentration = 15%
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- Test item concentration = 30%
- Parameter:
- EC3
- Value:
- > 30
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dilithium adipate would not be regarded as a skin sensitizer.
- Executive summary:
This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.
Referenceopen allclose all
No irritation and no signs of systemic toxicity were observed in any of the animals.
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.
No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.
No irritation and no signs of systemic toxicity were observed in any of the animals.
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.
No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The source and target substances are likely to dissociate after administration into metals ions and fatty acids due to the ionic bond between the metal cation and fatty acid ion being disrupted by polar aqueous media. The fatty acid component is not expected to be hazardous as it is potentially exempt from REACH under Annex V. The main difference between source and target substances is the cation and therefore test organisms would be exposed to either calcium from the target substance or lithium from the source substance. Although the cations are different, read across from lithium adipate is considered to be appropriate for skin sensitisation as both lithium and calcium show a similar lack of toxicity for this endpoint.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification is required for calcium dioctanoate based on read across from dilithium adipate. The stimulation index was <3 in an LLNA study conducted with dilithium adipate.
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.
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