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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003/10/15 - 2003/11/18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Pentanedioic acid, lithium salt (1:2)
- EC Number:
- 608-319-2
- Cas Number:
- 29126-51-0
- Molecular formula:
- C5H8O4.2Li
- IUPAC Name:
- Pentanedioic acid, lithium salt (1:2)
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ExxonMobil Research and Engineering (Paulsboro, New Jersey)
- Expiration date of the lot/batch: July 2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle: the test substance was soluble in the vehicle at the concentrations used during the study
Test animals
- Species:
- rat
- Strain:
- other: crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS:
TEST ANIMALS
- Source: CHarles River Laboratories
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 211-253 grams
- Fasting period before study: 18 hours
- Housing: single housed
- Diet (e.g. ad libitum): PMI Certified Rodent Diet Meal 5002, ad libitum
- Water (e.g. ad libitum): Deionized water, ad libitum
- Acclimation period: 7-28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64 - 72 degrees Fahrenheit
- Humidity (%): 30 to 70 percent relative humidity
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
IN-LIFE DATES: From: 2003/10/15 To: 2003/11/18
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Deionized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 0.88 mL/kg, 2.75 mL/kg, and 10 mL/kg for dose groups 175 mg/kg, 550 mg/kg and 2000 mg/kg respectively
- Justification for choice of vehicle: Test substance was soluble in chosen vehicle over duration of study
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg fasted body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Per OECD Test Guideline 425 a single female was initially dosed with 2,000 mg/kg. - Doses:
- 175 mg/kg, 550 mg/kg and 2,000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded on the day prior to dosing, on the day of dosing (Day 0), on Day 7, and Day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Animals were observed for mortality twice daily. Clinical observations were made at 30 minutes, 1, 2, 4, and 6 hours after dosing and once per day - Statistics:
- Statistical analyses included calculating the means and standard deviations of body weight and body weight change by group and sex. The oral median lethal dose (LD50) was calculated using the AOT425StatPgm software.
Results and discussion
- Preliminary study:
- Per OECD test guideline 425, one female was initially dosed with 2,000 mg/kg, this animal was found dead on Day 1. The subsequent animal was then treated with 175 mg/kg as the standard starting dose to avoid biasing the LD50 towards 2000 mg/kg.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 098 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 550 - 2 000
- Clinical signs:
- Clinical signs were only evident in the 2000 mg/kg animals. These signs included hypothermia, prostration, hypopnea, dyspnea, ocular discharge, soft stool, mucoidal stool and staining of the fur in the ano-genital area.
- Gross pathology:
- Gross postmortem examination of the animals that were found dead during the study included ano-genital staining, small intestine and cecum distended with gas
and yellow liquid and the stomach distended with gas and yellow liquid. All other animals were free of gross postmortem abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 for Dilithium Glutarate following oral intubation was established at 1098 mg/kg for females. These findings warrant classification of Dilithium Glutarate as an acute oral toxicant Category 4 under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
Dilithium Glutarate was administered via oral intubation to Crl:CD(SD) rats (8 females) at doses of 175, 550, and 2000 mg/kg to assess the acute oral toxicity. Animals were observed daily for 14 days post dosing. Overt signs of toxicity were apparent at a dose level of 2000 mg/kg. Mortality was observed only at 2000 mg/kg and all of the animals that succumbed following administration of Dilithium Glutarate died within 1 day of dosing. The incidence of death was considered dose related. All animals which survived to study termination were free of abnormalities at postmortem examination. All surviving animals displayed increases in body weight over their Day 0 values. The LD50 for Dilithium Glutarate was established at 1098 mg/kg for females. These findings warrant classification of Dilithium Glutarate as an acute oral toxicant Category 4 under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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