Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-030-1 | CAS number: 68514-28-3
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from January 7, 2008 to April 18, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Humic acids, potassium salts
- EC Number:
- 271-030-1
- EC Name:
- Humic acids, potassium salts
- Cas Number:
- 68514-28-3
- Molecular formula:
- NA
- IUPAC Name:
- tetrapotassium 17-[(2-{3-[(carbamoylmethyl)amino]-4-{[10-(carboxylatomethyl)-7-hydroxy-1,4-dioxo-8-({2,3',4'-trihydroxy-[1,1'-biphenyl]-5-yl}oxy)-4,10-dihydro-1H-phenoxazin-2-yl]oxy}phenyl}-7-oxo-3-[(2,3,4,5-tetrahydroxy-6-oxohexanoyl)oxy]-3,7-dihydro-2H-indol-5-yl)oxy]-2,5,16-trihydroxy-20,21-dioxo-10-oxapentacyclo[11.8.0.0³,¹¹.0⁴,⁹.0¹⁴,¹⁹]henicosa-1,3(11),4(9),5,7,12,14(19),15,17-nonaene-6,7-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Humic acids, potassium salts
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 16. 5. 2007/R
- Expiration date of the lot/batch: 05/2022
- Stability under test conditions: stable
- Storage condition of test material: dry conditions
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Metabolic activation:
- with and without
- Metabolic activation system:
- The post-mitochondrial fraction (S9) from rat liver and a mixture of cofactors
- Test concentrations with justification for top dose:
- Priliminary test: 0.5, 1.0, 2.0, 2.5, 3.0 and 5.0 mg/mL of final culture
Main test: 0.5, 1.0 and 2.5 mg/mL of final culture - Vehicle / solvent:
- - Vehicle used: sterile water
- Justification for choice of solvent/vehicle: Solubility in water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- yes
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- other: Thiotepa (Triethylenethiophosphoramide)
- Details on test system and experimental conditions:
- Test System:
Cells: Human peripheral blood lymphocytes (25 mL whole blood treated with heparin)
Donor: Healthy adult female volunteer
Instructions for storage: 4-8ºC
Lymphocyte Mitogen: Phytohaemagglutinin
Normal Cell Cycle Time: 16-20 hours
Modal Chromosome Number: 46 chromosomes - Evaluation criteria:
- Evaluation of Results
The result is considered positive if the test substance increases the average % frequency of aberrant cells to more than twice that of the negative control value (solvent=water). The values of the historical negative controls are among 0-5% of aberrant cells. The criteria for positive results must also include the two-fofld rule (increase in the number of chromosomal aberration) , the dose-response relationship and reproducibility of the results in repeated test.
Positive results in the vitro cytogenetic assay indicate that under the conditions used the test substance induces chromosomal aberrations in cultured mammalian somatic cells. Negative results indicate that the substance does not induce significant number of chromosomal aberrations in mammalian somatic cells.
Results and discussion
Test results
- Species / strain:
- lymphocytes: Human peripheral blood lymphycytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- doses above 3 mg/mL highly toxic
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
-
COMPARISON WITH HISTORICAL CONTROL DATA:
The data of positive controls and negative control (water) are in agreement with historical control data.
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Preliminary test
Exposition: 4 hours |
|||
A- mg/mL |
% AB.B. |
A+ mg/mL |
% AB.B. |
5.0 |
* |
5.0 |
* |
3.0 |
* |
3.0 |
* |
2.5 |
3.0 |
2.5 |
1.0 |
2.0 |
1.0 |
2.0 |
2.0 |
1.0 |
3.0 |
1.0 |
2.0 |
0.5 |
4.0 |
0.5 |
4.0 |
Ko |
1.0 |
Ko A |
3.0 |
Ko |
4.0 |
Ko A |
2.0 |
TT |
12.0 |
CP A |
11.0 |
TT |
8.0 |
CP A |
12.0 |
Main test
1st Test (4 hours) |
2nd Test (26 hours) |
||||
A- mg/mL |
% AB.B. |
A+ mg/mL |
% AB.B. |
A- mg/mL |
% AB.B. |
2.5 |
2.0 |
2.5 |
2.0 |
2.5 |
0.5 |
1.0 |
1.0 |
1.0 |
2.0 |
1.0 |
2.5 |
0.5 |
2.5 |
0.5 |
1.0 |
0.5 |
0.5 |
Ko |
1.0 |
Ko A |
2.0 |
Ko |
1.0 |
Ko |
1.0 |
Ko A |
2.0 |
Ko |
3.0 |
TT |
15.0 |
CP A |
8.0 |
TT |
14.0 |
TT |
15.0 |
CP A |
10.0 |
TT |
11.0 |
% AB.B. Frequency of aberrant cells
A- Without activation
A+ With activation
* High toxicity
Ko Negative control
Ko A Negative control with activation
TT Thiotepa
CP A Cyclophosphamide
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The potential clastogenicity of the test substance was tested by In Vitro Mammalian Chromosome Aberration Test. The test was carried out in human peripheral blood lymphocytes with and without metabolic activation system in two separate assays using three concentration levels of 0.5, 1.0 and 2.5 mg/mL of culture.
The negative results obtained indicate that, under the test conditions, the test substance does not induce structural chromosome aberrations in cultured mammalian somatic cells. - Executive summary:
The clastogenicity potential of the test substance was determined using In Vitro Mammalian Chromosome Aberration Test.
The study was performed acocording to the OECD Guideline for the Testing of Chemicals No. 473, 1977.
The test was carried out in human peripheral blood lymphocytes with and without metabolic activation system in two separate assays.
A range of six concentrations of test substance in water solution was used in the preliminary testing with and without metabolic activation: 0.5, 1, 2, 2.5, 3 and 5 mg/mL of culture. The doses 2.0, 2.5 mg/mL partially inhibited cell activation, doses above 3 mg/mL of culture were evaluated as highly toxic.
Three concentrations - 0.5, 1.0 and 2.5 mg/mL of test substance were used in the main test. At predetermined intervals (4 and 26 hours) after exposure of cell cultures to the test substance, cells were arrested at metaphase with colchicine, harvested and slides stained. Metaphase cells were analysed microscopically for the presence of chromosome aberrations. A total of 200 well-spread metaphases were examined per concentration on coded slides. Concurrent positive (Cyclophosphamide, Thiotepa) and negative (water) controls were included in each experiment.
Under the test conditions the test substance does not induce increase of structural chromosome aberrations in cultured human peripheral blood lymphocytes.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.