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Diss Factsheets
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EC number: 235-627-0 | CAS number: 12389-75-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: 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:
- other: Comparable to guideline study with acceptable restrictions For read-across justification refer to section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Further evidence for the aneuploidogenic properties of chelating agents: induction of micronuclei in mouse male germ cells by EDTA
- Author:
- Russo A, Levis AGl
- Year:
- 1 992
- Bibliographic source:
- Environ Mol Mutagen 19, 125-131
Materials and methods
- Principles of method if other than guideline:
- In vivo mouse micronucleus assay
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 6381-92-6
- Cas Number:
- 6381-92-6
- IUPAC Name:
- 6381-92-6
- Test material form:
- solid - liquid: suspension
- Details on test material:
- Disodium EDTA dihydrate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italy
- Age at study initiation: 8 -12 weeks
Administration / exposure
- Route of administration:
- intraperitoneal
- Details on exposure:
- - Application volume: 10 ml/kg bw
- Duration of treatment / exposure:
- 24 or 48 h (2 treatment sacrifice intervals)
- Frequency of treatment:
- single treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
186 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 6 control animals
3 for the 24 h interval
at least 4 for the 48 h interval - Control animals:
- yes
- Positive control(s):
- 1 mg/kg bw Mitomycin C
Examinations
- Tissues and cell types examined:
- bone marrow; polychromatic erythrocytes
- Details of tissue and slide preparation:
- Bone marrow smears were prepared following a standard protocol [MacGregor et al., 1987]
- Evaluation criteria:
- The frequency of MN induced in bone marrow was estimated by scoring 2,000 polychromatic erythrocytes (PCE) per animal at both time intervals. The frequency of normochromatic erythrocytes (NCE) was also assessed, to verify the possible cytotoxicity of each tested dose through the PCE/NCE ratio.
- Statistics:
- The frequencies of MN observed in each experimental group were pooled and the significance of differences between treated and control groups were evaluated by using the G test. The mean frequency of aberrations per cell and the PCE/NCE ratio were compared by the Student t-test after square root transformation of values.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Frequency of MN in Bone Marrow PCEs After Treatment With EDTA at Two Time Intervals
PCE |
NCE |
PCE/NCE ratio |
|||
Total |
+MN ( ‰ ± SE) |
Total |
+MN ( ‰ ± SE) |
PCE/NCE |
|
Controls |
11,810 |
21 (1 .8 ± 0.4) |
12,014 |
14 (1.2 ± 0.3) |
1.09 ± 0.09 |
MMC 24 hr |
6,149 |
93 (15.1 ± 1.6)*** |
6,085 |
22 (3.6 ± 0.8) |
1.01 ± 0.05 |
MMC 48 hr |
8,302 |
89 (10.7 ± 1.1)*** |
9,881 |
70 ( .1 ± 0.8) |
0.87 ± 0.08 |
EDTA 24 hr |
12,153 |
18 (1 .5 ± 0.3) |
13,820 |
15 (1 .1 ± 0 .3) |
0 .94 ± 0.1 1 |
EDTA 48 hr |
8,019 |
20 (2 .5 ± 0.6) |
7,514 |
15 (2 .0 ± 0.5) |
1 .05 ± 0 .09 |
PCE: polychromatic erythrocytes
NCE: normochromatic erythrocytes
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
EDTA-Na2H2 did not induce micronuclei in the bone marrow of male mice following ip injection. - Executive summary:
In the present study the effects of EDTA-Na2H2 dihydrate and two clastogens, adriamycin (ADM) and mitomycin C (MMC), and of the aneuploidogenic agent chloral hydrate (CH) were evaluated for the induction of micronuclei in bone marrow. All compounds were tested at a single dose level and at two time intervals, 24 and 48 h. EDTA-Na2H2 did not induce micronuclei in the bone marrow of male mice following ip injection.
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