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EC number: 232-235-1 | CAS number: 7790-98-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-01-20 to 1998-06-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Suboptimal GLP quality; adequate coherence between data, comments and conclusions; deviations to guideline; vehicle control inappropriate (saline although test item was dissolved in distilled water)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same 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:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- yes
- Remarks:
- from EC B.12: top-dose did not induce overt toxicity and was below the recommendation of 2000 mg/kg
- GLP compliance:
- yes
- Remarks:
- No laboratory compliance certificate. No analytical certificate for test item. Test item characterization insufficient. No study director-signed GLP declaration.
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Ammonium perchlorate
- EC Number:
- 232-235-1
- EC Name:
- Ammonium perchlorate
- Cas Number:
- 7790-98-9
- Molecular formula:
- ClHO4.H3N
- IUPAC Name:
- ammonium perchlorate
- Details on test material:
- - Substance type: MCP
- Physical state: solid powder*
- Nominal purity: 99.8%*
- Lot/batch No.: 03907LF
- Expiration date of the lot/batch: not indicated
- Stability under test conditions: not indicated but stability verified in drinking water*
- Storage condition of test material: at room temperature
*: not reported (insufficient test item characterization), but available for the same batch in other studies under 7.8.2
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: approx. 9-11 weeks (not specified)
- Weight at study initiation: 24-32 g
- Assigned to test groups randomly: yes, by body weight
- Fasting period before study: no
- Housing: 5/cage for F, individual for M
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: not indicated
ENVIRONMENTAL CONDITIONS not indicated
IN-LIFE DATES: not indicated
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Sterile distilled water
- Justification for choice of solvent/vehicle: highly soluble
- Concentration of test material in vehicle: 50-400 g/L (-> top dose above water solubility limit)
- Amount of vehicle (if gavage or dermal): 10 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
dissolved freshly before dosing - Duration of treatment / exposure:
- see below
- Frequency of treatment:
- Range-finding: up to three times at 24-h intervals
Main test: three times at 24-h intervals - Post exposure period:
- all sacrifices 24-h after last dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
62.5, 125, 250, 500 and 1000 mg/kg/day
Basis:
actual ingested
main test
- No. of animals per sex per dose:
- 5 (main test)
- Control animals:
- other: physiological saline, invalid (distilled water was the vehicle)
- Positive control(s):
- - cyclophosphamide
- Justification for choice of positive control(s): clastogen
- Route of administration: i.p.
- Doses / concentrations: 20 mg/kg once
Examinations
- Tissues and cell types examined:
- Femoral bone marrow - polychromatic and normochromatic erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: see results
DETAILS OF SLIDE PREPARATION:
Smears -> slides; MGG staining
METHOD OF ANALYSIS:
range-finding + main test: random observation of 1000 erythrocytes for myelotoxicity determination (polychromatic and normochromatic)
main test only: random observation of 1000 polychromatic erythrocytes for micronucleus determination - Evaluation criteria:
- Compared statistically and vs. background frequencies
- Statistics:
- ANOVA, Student t-test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- bone marrow: none; general: lethal at 2000 mg/kg
- Vehicle controls validity:
- other: valid but wrong vehicle
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- 5/6 dead within 30 min of 1st dose at 4000 mg/kg;
- 4/6 dead within 24h of 1st dose at 2000 mg/kg; survivors dosed twice at 1000 and 500 mg/kg: no death and no myelotoxic effect
- 4000 and 2000 mg/kg were respectively above and around the solubility limit (~200 g/L)
- Rationale for exposure: none indicated, but serum perchlorate levels evidenced in human studies after oral or inhalative exposures
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no, within background frequencies
- Ratio of PCE/NCE (for Micronucleus assay): within background frequencies
- Appropriateness of dose levels and route: yes
- Statistical evaluation: significant increase for positive control only
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Absence of in vivo genotoxic potential in a standard assay at up to 1000 mg/kg (non-toxic dose, but close to the lethal dose of 2000 mg/kg). - Executive summary:
Ammonium perchlorate was provided to groups of 5 male and 5 female mice by gavage in distilled water, at up to 1000 mg/kg/day on three consecutive days. The bone marrow from each mouse was assessed for micronucleus formation at sacrifice. Cyclophosphamide was administered i.p. to additional mice, as a positive control.
- Vehicle control was invalid (wrong vehicle: physiological saline) but negative. This validates the study design's specificity.
- The positive control induced a significant, 8 to 10-fold increase in micronucleus frequency but no myelotoxicity. This validates the study design's sensitivity.
- Ammonium perchlorate induced no significant increase in micronucleus frequency or myelotoxicity vs. vehicle controls or historical frequencies. The top-dose was expected to be toxic as it was close to the lethal dose of 2000 mg/kg (after single dosing), but induced no toxicity.
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