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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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 guideline- and GLP-compliant study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- 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:
- Potassium perchlorate lot 03907LF obtained from 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: Charles River, MI
- Age at study initiation: 38-39 days
- Weight at study initiation: not reported
- Fasting period before study: not relevant
- Housing: individual (not during mating or lactation)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Rats were continuously exposed to levels of ammonium perchlorate in the drinking water
- Details on mating procedure:
- No details reported
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Continuous; pre-mating, during mating, gestation and lactation
- Frequency of treatment:
- Daily / continuous
- Details on study schedule:
- No further details
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.3, 3.0, 30 mg/kg bw/d
Basis:
other: target exposure levels
- No. of animals per sex per dose:
- 30
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No further details
- Positive control:
- Not required
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: Yes
- Time schedule for examinations: daily
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily - Oestrous cyclicity (parental animals):
- Yes (P generation females from 21 days pre-mating)
- Sperm parameters (parental animals):
- Parameters examined in [all/P/F1 male parental generations
- Litter observations:
- Litters were observed twice daily for viability; dead pups were necropsied. Offspring were observed daily for clinical signs. Bodyweights were recorded at Day 1, 4, 7, 14 and 21. Sexual maturation was assessed.
- Postmortem examinations (parental animals):
- Gross necropsy, sperm analysis, deatiled histopathology (control and high dose); thyroid (all groups)
- Postmortem examinations (offspring):
- At least 3 pups/sex/litter (F2) were necropsied; histopathology was perfomred on the adrenals, brain, thyroids, liver, spleen, kidneys and thymus. Pooled blood samples were assesed fo T3, T4 and TSH levels.
- Statistics:
- Various tests were employed
- Reproductive indices:
- Mating and lactation indices reported
- Offspring viability indices:
- Viability and survival indices reported
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- thyroid pathology at 3 and 30 mg/kg bw/d
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not examined
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on fertility or reproducitve parameters seen at the highest dose level
- Remarks on result:
- other: Generation: reproductive toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Increased thyroid weights and thyroid hyperplasia at 3.0 mg/kg bw//d and above
- Remarks on result:
- other: Generation: parental toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Increased thyroid weight at 3.0 mg/kg bw/d and above
- Remarks on result:
- other: Generation: offspring (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased thyroid weight at 3 and 30 mg/kg bw/d
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- thyroid histopathology at 3 and 30 mg/kg bw/d
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
No effects of treatment were seen on reproductive parameters in this study.
Applicant's summary and conclusion
- Conclusions:
- No effects of treatment were seen on reproductive parameters in this study.
- Executive summary:
This two-generation reproductive toxicity study was performed to examine the effects of ammonium perchlorate on the male and female reproductive systems in rats, and on the growth and development of offspring. Adult Sprague-Dawley rats (30/sex/group) were given continuous access to ammonium perchlorate in their drinking water at doses of 0, 0.3, 3.0, and 30.0 mg/kg bw/d. F1 generation rats were given the same ammonium perchlorate doses as the P1 generation beginning at weaning and continuing through to the day of sacrifice. Standard reproductive parameters were evaluated; additionally blood was collected for determination of serum thyroid-stimulating hormone (TSH), triiodothyronine (T3), and thyroxine (T4) levels. Histopathological examinations were conducted on major tissues, including the thyroid. No significant changes in developmental parameters were observed. In the F1 generation adult rats, relative thyroid weights were significantly increased in all dose groups for female rats and in the 3.0 and 30.0 mg/kg bw/d dose groups for male rats. Histopathological changes in the thyroid consisted of hypertrophy and hyperplasia that increased in incidence and severity in a dose-related manner. Dose-related, statistically significant changes in TSH and T4 or T3 occurred at doses higher than those that resulted in changes in thyroid weight and thyroid histopathology, 30 mg/kg bw/d. It is therefore concluded that perchlorate is not a reproductive toxicant in rats when administered in the drinking water at doses up to 30 mg/kg bw/d, but it can affect the thyroid at dose levels of ≥3 mg/kg bw/d. Based on these findings, the authors identify 0.3 mg/kg bw/d as a NOAEL for this study.
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