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EC number: 407-370-6 | CAS number: 133986-51-3
- 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 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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Micronuclei induction in germ cells of the mouse was evaluated after after i.p. application. Due to the very alkaline character of the test and its application very close to the gonads the route of application chosen in this test is not suitable and results obtained are considered to be equivocal. 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 AG
- Year:
- 1 992
- Bibliographic source:
- Environ Mol Mutagen 19, 125-131
Materials and methods
- Principles of method if other than guideline:
- Micronuclei induction in germ cells of the mouse were evaluated after after i.p. application. In a second set of experiments chromosomal aberrations in mouse spermatogonia were determined.
- 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:
- - TS = 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:
other: actually applied
- 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):
- 5.5 mg/kg bw Adriamycin
Examinations
- Tissues and cell types examined:
- spermatids
- Evaluation criteria:
- The presence of MN was assessed on both Golgi and Cap phases of spermatid development, by scoring a minimum of 1000 Golgi phase spermatids per animal, and the Cap phase cells observed at the same time.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- see table 1
- Toxicity:
- not specified
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Frequency of MN in early spermatids at two time intervals
Golgi phase |
Cap phase |
|||
Total |
+MN (‰ ± SE) |
Total |
+MN (‰ ± SE) |
|
Controls |
6,201 |
5 (0.8 ± 0.4) |
5,836 |
3 (0.5 ± 0.3 ) |
ADM 24 hr |
3,327 |
0 |
4,493 |
3 (0 .7 ± 0 .4) |
ADM 48 hr |
4,023 |
18 (4 .5 ± 1. 1)*** |
4,070 |
17 (4.2 ± 1.0)** * |
EDTA 24 hr |
2,993 |
9 (3.0 ± 1.0)* |
3,436 |
2 (0 .6 ± 0 .4) |
EDTA 48 hr |
4,010 |
15 (3 .8 ± 1 .0)*** |
3,541 |
2 (0 .9 ± 0 .4 ) |
It was speculated by the authors whether EDTA induced MN either because of an S-independent clastogenic action of the compound under study, or for chromosome lagging.
Table 2: Chromosomal aberrations in mouse spermatogonia detected 24 h after treatment
|
Metaphases scored |
Aberrations per cell |
|
Total |
Aberrant |
||
Controls |
200 |
1 |
0.005 +/- 0.0004 |
MMC |
300 |
11 |
0.037 +/- 0.002 *** |
ADM |
201 |
15 |
0.085 +/- 0.007 *** |
CH |
247 |
2 |
0.008 +/- 0.0005 |
EDTA |
400 |
2 |
0.005 +/- 0.0002 |
*** p<0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
The results obtained indicate that EDTA-Na2H2 is able to induce micronuclei at meiosis. On the contrary, EDTA-Na2H2 did not induce chromosomal aberrations in mouse spermatogonia. Therefore, the most probable origin of micronuclei produced by EDTA is whole chromosome lagging. These results provide further evidence for the aneuploidogenic properties of these chelating agents. - Executive summary:
A micronucleus assay based on cytogenetic analysis of early spermatids (Tates et al. Mutation Research 121, 131 -138, 1983) was applied to determine if the chelating agent ethylenedinitrilotetraacetic acid (EDTA) may induce aneuploidy in mouse meiotic cells. Previous results indicated aneuploidogenic activity of EDTA in Drosophila female germ cells (induction of chromosome loss; Zordan et al., Environ Mol Mutagen 15:205-213, 1990). In the same study, a standard aneuploidy test based on chromosome counting in mouse secondary spermatocytes failed however to show aneuploidogenic properties of EDTA in mouse somatic and germ cells. In the present study the effects of two clastogens, adriamycin (ADM) and mitomycin C (MMC), and of the aneuploidogenic agent chloral hydrate (CH) were also evaluated. All compounds were tested at a single dose level and at two time intervals corresponding to the treatment of diakinesis / metaphase I /metaphase II spermatocytes. The clastogenic potential of the compounds under study was also evaluated, by chromosomal aberration analysis in mouse spermatogonia, in an independent set of experiments. The results obtained indicate that ADM, CH and EDTA are able to induce micronuclei at meiosis. On the contrary, only ADM and MMC induced chromosomal aberrations in mouse spermatogonia. Therefore, the most probable origin of micronuclei produced by CH and EDTA is whole
chromosome lagging. These results provide further evidence for the aneuploidogenic properties of these chelating agents.
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