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Diss Factsheets
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EC number: 608-319-2 | CAS number: 29126-51-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Dilithium adipate
- EC Number:
- 242-449-7
- EC Name:
- Dilithium adipate
- Cas Number:
- 18621-94-8
- Molecular formula:
- C6H8O4.2Li
- IUPAC Name:
- dilithium adipate
- Reference substance name:
- Dilithium hexanedioate
- IUPAC Name:
- Dilithium hexanedioate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Dilithium adipate
- Molecular formula: C6H8O4.2Li
- Molecular weight: 158 g/mol
- Physical state: Powder
- Analytical purity: 100 %
- Lot/batch No.: A049/99
- Expiration date of the lot/batch: 06 March 2018
- Stability under test conditions: Not reported
- Storage condition of test material: At room temperature protected from light
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: dilithium adipate- Molecular formula: C6H8O4.2Li- Molecular weight: 158- Physical state: white powder- Analytical purity: 100%- Lot/batch No.: A049/99- Expiration date of the lot/batch: 6 March 2018- Storage condition of test material: At room temperature protected from light
In vivo test system
Test animals
- 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 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18-24- Humidity (%): 40-70- Air changes (per hr): 10- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- 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: 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
CHALLENGE EXPOSURE- 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):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 2% w/w test item
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 15% w/w test item
- Key result
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 30% w/w test item
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Murine Local Lymph Node Assay to assess the skin sensitization potential of Dilithium Adipate was negative. This finding does not warrant the classification of Dilithium Adipate as a skin sensitizer under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
Dilithium Adipate was examined for its potential to be a skin sensitizer using the Murine Local Lymph Node Assay. Following a preliminary range finding test, 5 CBA mice were treated by dermal application of 2, 5, and 15% w/w Dilithium Adipate in acetone/olive oil (4:1 v/v) to induce sensitization. No indication of sensitization was noted. This finding does not warrant the classification of Dilithium Adipate as a skin sensitizer under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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