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EC number: 251-908-0 | CAS number: 34274-28-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 12/96 final draft
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- [nitrilotris(methylene)]trisphosphonic acid, sodium salt
- EC Number:
- 243-900-0
- EC Name:
- [nitrilotris(methylene)]trisphosphonic acid, sodium salt
- Cas Number:
- 20592-85-2
- Molecular formula:
- General formula C3H12NO9P3.xNa where x=3-5 ATMP-3Na C3H9NNa3O9P3 ATMP-4Na C3H8NNa4O9P3 ATMP-5Na C3H7NNa5O9P3
- IUPAC Name:
- Sodium salt of [nitrilotris(methylene)]trisphosphonic acid (3-5Na:1)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crl: CD-1 (ICR) BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labs Raleigh NC
- Age at study initiation: approx 8 weeks
- Weight at study initiation: 30.6 - 33.9 g (males); 23.6-28.4 g (females)
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: 5 animals per polycarbonate cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Amount of vehicle (if gavage or dermal): 10 ml/kg - Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- 24, 48h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Range finding experiments: 3 male and 3 female per dose; 6 males per dose in main experiment.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - cyclophosphamide;
- Justification for choice of positive control(s): none given
- Route of administration: oral gavage
- Doses / concentrations: 80 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Based on two range-finding studies.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 500 mg/kg bw, 1000 mg/kg bw and positive control harvested at 24 hours; 2000 mg/kg bw and vehicle control harvested at 24 and 48 hours.
DETAILS OF SLIDE PREPARATION: Giesma stain
METHOD OF ANALYSIS: scored for micronuclei and PCE NCE ratio - Evaluation criteria:
- Criteria for positive: Statistically significant increase in micronucleated PCEs or at least one dose level and a statistically significant dose-related response.
- Statistics:
- ANOVA followed by Dunnett's t-test when ANOVA positive
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- up to limit concentration
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
No clinical toxicity and no cytotoxicity to the bone marrow was observed in any treated animals. No increase in the frequency of micronucleated erythrocytes occurred in any test substance dose.
Table 1: Mean Results of in vivo micronucleus test in mouse bone marrow
- |
Solvent Control (water) |
Positive Control (Cyclophosphamide) |
Low dose 500 mg/kg |
Mid dose 1000 mg/kg |
High dose 2000 mg/kg |
||
Sampling time (h) |
24 |
48 |
24 |
24 |
48 |
24 |
48 |
Number of cells analysed |
2000 |
2000 |
2000 |
2000 |
2000 |
2000 |
2000 |
Micronucleated cells per animal % |
0.07 |
0.07 |
2.73 |
0.04 |
0.09 |
0.02 |
0.06 |
Ratio PCE/NCE |
0.52 |
0.47 |
0.50 |
0.59 |
0.44 |
0.41 |
0.60 |
Applicant's summary and conclusion
- Conclusions:
- ATMP-5Na has been tested for clastogenicity in vivo in a reliable study conducted according to OECD Test Guideline 474 and in compliance with GLP. No increase in the frequency of micronucleated erythrocytes was observed. It is concluded that ATMP-5Na is negative for the induction of micronuclei under the conditions of this test.
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