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Diss Factsheets
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EC number: 459-550-9 | CAS number: -
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, performed in conformity with GLP-principles
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Identity: LZ 1780
- Chemical name: L-Carnitine L-tartrate
- Lot number: 21205
- Expiry date: 09 December 2007
- Appearance: White crystalline powder
- Storage conditions: Room temperature
- Date received: 4 January 2006
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The test concentration was measured using a LC-MS/MS method of chemical analysis. At the start of the definitive test, four samples (20 ml) were taken from the freshly-prepared control and test media. After 48 hours, the contents of the vessels from each group were pooled and four samples (20 ml) were taken for analysis. On each occasion, the samples were stored frozen for up to six days before two samples from each batch were provided for analysis.
Test solutions
- Details on test solutions:
- Identity and concentration of auxiliary solvent for dispersal: The test medium was prepared by direct addition of the test substance to water. See also "details on analytical methods".
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Stock cultures of Daphnia magna were maintained in glass vessels containing approximately 0.8 litres of Elendt M4 culture medium in a temperature-controlled laboratory at nominally 20 ± 2°C. A photoperiod of 16 hours light : 8 hours dark was maintained, with periods of subdued lighting at the beginning and end of each light phase. The culture medium was renewed at least twice each week.
Cultures were fed daily with a mixed suspension of the unicellular green algae, Pseudokirchneriella subcapitata and Scenedesmus subspicatus, to provide nominally 0.1 to 0.2 mg carbon per daphnid, per day, except during the initial three days when a slightly lower ration was given. Culture conditions ensure that the stock animals reproduce by parthenogenesis.
The day before the start of the study, all juvenile Daphnia were removed from the laboratory cultures. The following morning, juveniles produced by the gravid (egg-bearing) adult Daphnia were removed from the culture vessels and held in a separate holding vessel; these animals, which were less than 24 hours old, were used in the test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 d
- Post exposure observation period:
- Observations of the Daphnia in each control and test vessel were made after approximately 24 and 48 hours.
Test conditions
- Hardness:
- The total hardness and alkalinity of the batch of Elendt M4 medium used were 268 and 42.5 mg/l as CaCO3, respectively.
- Test temperature:
- Temperatures were within the range 19.5 to 20°C.
- pH:
- The pH values were within the range 6.92 to 7.82.
- Dissolved oxygen:
- Dissolved oxygen concentrations were within the range 93 to 96% air saturation value (ASV).
- Salinity:
- Freshwater used.
- Nominal and measured concentrations:
- A group of twenty Daphnia, less than 24 hours old, was exposed for 48 hours to a dilution of LZ 1780 at a nominal concentration of 100 mg/l. The test medium was prepared in Elendt M4 medium by the direct addition of the test substance to the dilution medium.
The mean measured concentrations of LZ 1780 in samples of test medium ranged between 82 and 104% of the nominal value during the test, giving an overall mean measured level of 92.8 mg/l. - Details on test conditions:
- Environmental parameters remained within acceptable limits throughout the study.
- Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 92.8 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 92.8 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 92.8 mg/L
- Details on results:
- After 48 hours, no immobility had occurred.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute EC50 to Daphnia Magna was determined to be > 100 mg/l nominal (> 92.8 mg/l as mean measured concentration). Based on these results, the test item does not have to be classified and has no obligatory labelling requirement according to the European CLP-Regulations (GHS).
- Executive summary:
The test item was tested for acute toxicity to Daphnia Magna in a static test, according to OECD-Guideline No. 202, EU-Testing Method C.2 and in conformity with GLP-principles. The study was performed from January - February 2006.
The acute EC50 to Daphnia Magna was determined to be > 100 mg/l nominal (> 92.8 mg/l as mean measured concentration). Based on these results, the test item does not have to be classified and has no obligatory labelling requirement according to the European CLP-Regulations (GHS).
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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