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EC number: 943-389-0 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The reliability of the source read-across study was established to be R2: published study well documented
- Justification for type of information:
- Justification for read-across is detailed at section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of amino acids on sister-chromatid exchanges.
- Author:
- Zhang and Yang
- Year:
- 1 992
- Bibliographic source:
- Mutation Research, 280 (1992) 279-283
Materials and methods
- Principles of method if other than guideline:
- Sister chromatid exchange Human peripheral blood Lymphocytes.
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay in mammalian cells
Test material
- Reference substance name:
- Similar substance 2a
- IUPAC Name:
- Similar substance 2a
- Details on test material:
- Name: Lysine
CAS no.: 56-87-1
EC no.: 200-294-2
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human peripheral blood lymphocytes
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 0, 10, 50 and 100 µg/ml
- Vehicle / solvent:
- Saline solution
Controls
- Untreated negative controls:
- yes
- Details on test system and experimental conditions:
- METHOD OF APPLICATION
The whole-blood microculture technique was used. 0.4 ml of venous whole blood was inoculated to 5 ml of the culture medium.
CULTURE MEDIUM
- Composition: containing
41.6 mg of RPMI 1640 (JR Scientific Inc., Woodland, CA)
1 ml of fetal calf serum (purchased from Tianjin Medical College, China)
1.5 mg of PHA (produced by Guangdong Biological Product Institute, China)
10000 IU each of penicillin and streptomycin
0.1 ml of 5 % NaHCO3.
- pH: 7
INCUBATION
The mixture was incubated for 24 h. Bromodeoxyuridine (BrdU), at 10 µg/ml, was added at 24 h of culture.
At 48 h of culture, substance (dissolved in saline solution) or saline solution (for control) was added and the cultures were incubated for another 24 h.
HARVESTING
Peripheral Blood Lymphocytes (PBL) were harvested at the end of the 24 h exposure period (total culture time = 72 h) with 0.05 µg/ml colchicine being added 2 h before harvesting.
All cultures were incubated at 37 °C in the dark.
PBL, harvested after gentle centrifugation (1000 rpm, 10 min) and discarding the supernatant, were resuspended in 0.075 M KCI solution for hypotonic treatment for 20 min, centrifuged again, and finally fixed in methanolacetic acid solution (3:1) three times.
SLIDES PREPARATION
A few drops of the cell suspension were dropped onto a clean slide taken from icy water and frame-dried. The slides were incubated in 2 × SSC solution in petri dishes at 70 °C and irradiated simultaneously under a UV lamp (30 W) at a distance of 10 cm for 20 min. The preparations were stained in 3 % Giemsa solution for 10 min after being rinsed with tap water (Xing, 1990; Zhang, 1991).
SCE ANALYSIS
SCE analysis was carried out on cells having replicated for two cycles in the presence of BrdU. Ten metaphases were scored for each treatment. - Statistics:
- Statistical methods for analysis of variance (AOV) based on the square roots of SCE were used (Crossen, 1977; Morgan, 1977, 1981; Vercauteren, 1984)
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human peripheral blood lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Untreated negative controls validity:
- valid
- Additional information on results:
- After multiple comparisons, the effects of test article on SCE in PBL are not significant.
Further substances were involved in the test and divided into two groups with each group consisting of five substances. A randomized complete-block design was used to avoid the influence of individual differences on SCE. One person's blood was used for each test and regarded as one block. - Remarks on result:
- other: no mutagenic potential
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- No mutagenic potential
- Executive summary:
Effects of Target substance on SCE in PBL
The experimental data show that the treatment with test substance did not induce a significant increase in SCE. The test item is an essential substance for PBL growth. Thus, it was unexpected that the target substance can significantly induce SCE in PBL. We infer that the addition of exogenous substances might result in an imbalance among tested substances in the medium and cause metabolic disturbances in cells. This might further influence the activities of various enzymes and result in the induction of SCE.
However, this is only a hypothesis and the actual molecular mechanisms involved remain unsolved.
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