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EC number: 231-912-9 | CAS number: 7778-74-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published summary of a modern, GLP- and guideline-compliant study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium perchlorate
- EC Number:
- 232-235-1
- EC Name:
- Ammonium perchlorate
- Cas Number:
- 7790-98-9
- IUPAC Name:
- ammonium perchlorate
- Test material form:
- not specified
- Details on test material:
- Ammonium perchlorate (Aldrich); 99.8% purity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Springborn Ohio
- Age at study initiation: 7 weeks
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 15
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Selective ion chromatography (HPLC)
- Duration of treatment / exposure:
- 90-days
- Frequency of treatment:
- Daily / continuous (in drinking water)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.1, 0.5, 0.2, 1, 10 mg/kg bw/d
Basis:
other: target dose level
- No. of animals per sex per dose:
- 30
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Dose selection was based on a 14-day pilot study and was intended to identify a NOAEL for effects on thyroid hormone levels
- Positive control:
- Not required
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Time schedule: weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: pre-test, Day 90, Day 120 (recovery)
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Days 14, 90, 120 (recovery)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Days 14, 90, 120 (recovery)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: oestrus cycling, measurement of throid hormone levels (T3, T4, TSH) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes - all animals
HISTOPATHOLOGY: Yes - comprehensive - Other examinations:
- Sperm analysis was performed on all males at termination on Days 90 or 120.
Bone marrow PCEs were assessed for the incidence of micronuclei. - Statistics:
- ANOVA, Chi-square test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- effeccts on TSH and thyroid hormones in all treated groups
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- increased thyroid weight (absolute and relative) at 10 mg/kg bw/d
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- thyroid histopathology at 10 mg/kg bw/d
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- The effects of treatment in this study were limited to the thyroid. Increased TSH and reduced T3 and T4 levels were seen in all treated groups; findings were associated with increased thyroid weight and histopathology at the highest dose level of 10 mg/kg bw/d.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Statistically significant changes in TSH and thyroid hormone levels were seen in all groups but were not accompanied by changes in thyroid weight or histopathology at 1 or 10 mg/kg bw/d
- Dose descriptor:
- LOEL
- Effect level:
- 0.01 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Statistically significant changes in TSH and thyroid hormone levels were seen in all group
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
A NOEL cannot be determined for this study due to effects on TSH and thyroid hormone levels in all treated groups. However the authors conclude a NOAEL of 1 mg/kg bw/d in the absence of any effects on thyroid weight and histopathology with the exception of the highest dose group (10 mg/kg bw/d).
Applicant's summary and conclusion
- Conclusions:
- The study identified the thyroid as the target of toxicity for ammonium perchlorate. A NOEL cannot be determined for this study due to effects on TSH and thyroid hormone levels in all treated groups. However the authors conclude a NOAEL of 1 mg/kg bw/d in the absence of any effects on thyroid weight and histopathology with the exception of the highest dose group (10 mg/kg bw/d).
- Executive summary:
The purpose of this study was to evaluate the subchronic toxicity of perchlorate when administered to Sprague-Dawley rats as ammonium perchlorate (AP) for 14 or 90 days. The study consisted of an untreated control group and five treatment groups that received continuous exposure to AP via the drinking water at dosage levels of 0.01, 0.05, 0.2, 1.0, and 10.0 mg/kg/day. The study design included a nontreatment recovery period of 30 days to evaluate the reversibility of any AP-induced effects at the 0.05, 1.0, and 10.0 mg/kg/day levels. The study also investigated the potential effects of AP on male sperm parameters, female estrous cyclicity, bone marrow micronucleus formation, and serum hormone levels, i.e., triiodothyronine (T(3)), thyroxine (T(4)), and thyroid stimulating hormone (TSH). No toxicologically meaningful differences were observed between the control and AP-treated groups with respect to survival, clinical observations, body weights, food consumption, water consumption, ophthalmology, hematology, clinical chemistry, estrous cycling, sperm parameters, or bone marrow micronucleus formation. A target organ effect was produced by AP in the thyroids of male and female rats at the 10 mg/kg/day level after 14 and 90 days of exposure. The effect was characterized by significantly increased thyroid weights and thyroid histopathology consisting primarily of follicular cell hypertrophy with microfollicle formation and colloid depletion. These changes were reversible after a nontreatment recovery period of 30 days. Statistically significant changes in TSH and thyroid hormones were observed at all AP dosage levels tested; however, no thyroid organ weight or histopathological effects were observed at AP dosage levels < or = 1.0 mg/kg/day. In the absence of thyroid organ weight and histopathological effects, the toxicological significance of TSH and thyroid hormone changes at AP dosage levels < or = 1.0 mg/kg/day remains to be determined.
A NOEL cannot be determined for this study due to effects on TSH and thyroid hormone levels in all treated groups. However the authors conclude a NOAEL of 1 mg/kg bw/d in the absence of any effects on thyroid weight and histopathology with the exception of the highest dose group (10 mg/kg bw/d).
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