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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1999 - September 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Sufficiently compliant to GLP; adequate coherence between data, comments and conclusions. The top-dose was not based on dose-limiting toxicity but on antithyroid effects (not verified in this study), limiting the sensitivity of the study for Developmental Effects classification. Loss indices were not reported but could be determined by Summary author. The other deviations to OECD 414 guideline have no impact on the reliability and completeness of the conclusions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.3700 (Reproduction and Fertility effects)
- Deviations:
- not applicable
- Remarks:
- the guideline quoted does not exist (mistake in report)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Treatment period exceeds requirements. Temperature (°C): 18-26 instd. of 19-25. Highest dose did not induce clinical signs or lower weight gain and was < 1000 mg/kg/day. % Pre/Post-implantation loss not reported. Historical control data are inadequate.
- GLP compliance:
- yes
- Remarks:
- No laboratory compliance certificate. Analytical certificate does not check test item purity. Perchlorate concentrations were outside the range validated for stability during about half of the study, at the top-dose.
- Limit test:
- no
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% (not verified)
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- NB: The whole summary ignores male rats (although they were exposed during mating) since they are normally not included in a teratogenicity study.
TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 213-237 g
- Fasting period before study: no
- Housing: stainless steel wire-bottomed cages, individual except during mating
- Diet (e.g. ad libitum): PMI Certified Rodent Diet, ad libitum
- Water (e.g. ad libitum): reverse osmosis water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2000-01-25 To: 2000-03-15
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Nature: reverse osmosis drinking water
- Justification for use and choice of vehicle: high solubility of the test item in water
- Lot/batch no. (if required): not applicable
- Purity: not applicable
- Less than 0.5 mg/L (LOD) of nitrate, a possible interference ion for perchlorate
PREPARATION OF TREATED DRINKING WATER:
- Dilution from a stock solution at 10 mg/mL
- Concentration adapted weekly (using body weight and water consumption) to reach the target dose-levels in mg/kg/day: 0.06-242 µg/mL
- Frequency of preparation: at least once a week (diluted solutions)
- Storage: refrigerated (stock solutions) / room temperature (diluted solutions) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Methods:
- validated ion chromatography method
- LOD for perchlorate and nitrate (interference ion): 0.005 µg/mL
Results:
- at all doses: concentrations within +/- 5% of nominals
- at 0.05 and 200 µg/mL: stable over 109 days at 21-22°C under light (12h/day) - demonstrated in another study (7.5.1)
Comments:
- For 3 out of 6 preparation occasions, the target concentrations at the high-dose were above the maximal concentration demonstrated to be stable (200 µg/mL).
- This validation otherwise adequately covers the study's test item use conditions. - Details on mating procedure:
- - Impregnation procedure: cohoused with treated males
- M/F ratio per cage: 1:1
- Length of cohabitation: 9 days
- No replacement of males or further mating, as only presumably pregnant females were assigned to gestation study.
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug or sperm in vaginal smear; referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 36 to 44 days: 14 days prior to mating, 1-9 days of mating, and 21 days of gestation before sacrifice
- Frequency of treatment:
- Continuous (treated water ad libitum)
- Duration of test:
- See in-life dates
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.01, 0.1, 1 and 30 mg/kg/day
Basis:
other: nominal dose; achieved dose within +/- 10% of nominal
- No. of animals per sex per dose:
- 24 females, among which 17 to 20 per group were considered pregnant and therefore analysed by cesarian section.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 10 mg/kg/day resulted in antithyroid effects in pups in a neurobehavioral study, and in adults in a 90-day study (7.5.1)
- Rationale for animal assignment: random
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily during pregnancy only
BODY WEIGHT: Yes
- Time schedule for examinations: twice during acclimation and daily throughout exposure period
FOOD CONSUMPTION: Yes
- Time schedule: daily throughout exposure period
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: weekly, individually
- Calculated as mg/kg/day from body weight data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: gross necropsy of all viscera. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: placental abnormalities - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- See page 24 of study report
- Indices:
- % Pre-implantation loss and % Post-implantation loss were not calculated in the report. Recalculated by RSS author as:
% Pre-implantation loss = 100 * (Number of corpora lutea - Number of implantation sites) / Number of corpora lutea
% Post-implantation loss = 100 * (Number of implantation sites - Number of live fetuses) / Number of implantation sites - Historical control data:
- Provided; same type of data, from the same laboratory in the same strain.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Alopecia in 3 top-dose females, not toxicologically relevant.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: minimal & non adverse
Details on embryotoxic / teratogenic effects:
There appeared to be an increase in % pre- and post-implantation losses* and a decrease in number of live fetuses, but dose-relationship was unclear and the number of implantation sites was unaffected by treatment. The effects are not considered as being toxicologically relevant. NB: an absence of impact on number of pups has been confirmed in a 2-generation study in rats treated at up to 30 mg/kg/day (see 7.8.1).
*: comparison with historical control impossible since these indices were not calculated in historical data.
There are 3% and 8% fewer ossification sites in sternum and forelimb phalanges, respectively, at 30 mg/kg/day vs. controls.** This effect is minimal, and not adverse: it represents a slight delay in development which is usually reversible.
**: the control group was already outside the historical range for sternal ossification sites: historical control data inadequate for interpretation.
No teratogenic effects.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Reproductive indices and ossification sites in rats treated with ammonium perchlorate
Dose (mg/kg/day) | 0 | 0.01 | 0.1 | 1 | 30 |
Corpora lutea | 19.3 | 17.9 | 18.1 | 19.8 | 19.8 |
Implantations | 17.0 | 14.7 | 14.4 | 16.6 | 14.8 |
Live fetuses | 16.6 | 14.3 | 13.9 | 16.2 | 14.1* |
% Pre-implantation loss @ | 11.9 | 17.9 | 20.4 | 16.2 | 25.3 |
% Post-implantation loss @ | 2.4 | 2.7 | 3.5 | 2.4 | 4.7 |
Ossification sites (per fetus per litter): | |||||
- Sternal center | 4.00 | 3.93 | 3.97 | 3.96 | 3.88** |
- Forelimb phalanges | 6.97 | 6.78 | 6.68 | 7.01 | 6.43* |
@: no statistical analysis performed since these data were not in the original report
*: p<0.05; **: p<0.01
Applicant's summary and conclusion
- Conclusions:
- Maternal NOAEL set at 30 mg/kg/day in the absence of relevant maternal effects.
Developmental NOAEL set at 30 mg/kg/day in the absence of adverse developmental abnormalities.
The top-dose was not based on dose-limiting toxicity but on antithyroid effects (not verified in this study), limiting the sensitivity of the study for Developmental Effects classification. - Executive summary:
Ammonium perchlorate was provided to groups of 24 female rats via drinking water, at dose-levels of 0 (control), 0.01, 0.1, 1 and 30 mg/kg/day before (2 weeks before mating, complete mating) and during gestation (21 days). Effects on thyroids were not investigated.
- At 30 mg/kg/day, there was no maternal toxicity. Pre- and Post-implantation loss indices were higher than in controls but this was not considered to represent relevant resorptions when considering the number of resorptions, implantation sites, live and dead fetuses. There was a minor indication of delayed ossification (fewer ossification sites). No developmental abnormalities were noted.
- At 0.01 to 1 mg/kg/day, neither maternal nor embryo-/feto- or developmental toxicities were noted.
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