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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
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:
- Obtained from Aldrich Chemical Company; 99.8% purity
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance, PA
- Age at study initiation: not stated
- Weight at study initiation: not stated
- Housing: no details
- Diet: 180 g/d
- Water: ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
No details
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Rabbits were exposed on Days 6-28 of gestation
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Dams were supplied assumed pregnant (naturallly mated)
- Duration of treatment / exposure:
- Rabbits were exposed on Days 6-28 of gestation
- Frequency of treatment:
- Daily / continuous
- Duration of test:
- Rabbits were exposed on Days 6-18 of gestation and terminated on Day 29
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 0.1, 1, 10, 30, 100 mg/kg bwd
Basis:
other: target dose levels
- Remarks:
- Doses / Concentrations:
0, 0.1, 0.9, 10.4, 30.3, 102.3 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal 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: yes
- Time schedule for examinations: daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day #29
- Organs examined: thyroids/parathyroids
OTHER: blood was collected from does for determination of serum thyroid stimulating hormone (TSH), triiodothyronine (T3), and thyroxine (T4) levels and the thyroid was subjected to histopathologic examination - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter - Statistics:
- Various tests were utilised
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal toxicity was limited to thyroid histopathology at dose levels of 10 mg/kg bw/d and higher, reduced T4 levels were also seen at 30 and 100 mg/kg bw/d
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 100 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:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No maternal deaths were attributed to perchlorate exposure. Ammonium perchlorate at dose levels up to 100.0 mg/kg bw/d did not affect uterine or litter parameters studied, and all values were found to be within the historical ranges of the laboratory. The litter averages forcorpora lutea, implantations, litter sizes, live and dead foetuses, percent dead or resorbed conceptuses, and fetal body weights were comparable and also did not differ significantly in the six dose groups. All placentae appeared normal and no dam had a litter consisting of only resorbed conceptuses. The maternal thyroid was identified as the target organ for ammonium perchlorate; increased incidences of thyroid follicular hypertrophy were observed in does treated with ≥10 mg/kg bw/d and significantly decreased T4 was observed in does treated with 30 mg/kg bw/d.
Applicant's summary and conclusion
- Conclusions:
- No evidence of developmental toxicity was seen under the conditions of this study. The thyroid was confirmed as the target of perchlorate toxicity.
- Executive summary:
A developmental toxicity study was conducted to evaluate the embryofoetal toxicity and teratogenic potential of ammonium perchlorate in New Zealand White [Hra:(NZW)SPF] rabbits. Pregnant rabbits were given continual access to ammonium perchlorate in drinking water at target doses of 0, 0.1, 1.0, 10.0, 30.0, and 100.0 mg/kg bw/d on gestation Days 6 -28 and were sacrificed on gestation Day 29. Blood was collected from does for determination of serum thyroid stimulating hormone (TSH), triiodothyronine (T3), and thyroxine (T4) levels and the thyroid was subjected to histopathologic examination. No maternal deaths were attributed to perchlorate exposure. Ammonium perchlorate at dose levels up to 100.0 mg/kg bw/d did not affect uterine or litter parameters studied, and all values were found to be within the historical ranges of the laboratory. The litter averages for corpora lutea, implantations, litter sizes, live and dead foetuses, percent dead or resorbed conceptuses, and fetal body weights were comparable and also did not differ significantly in the six dose groups. All placentae appeared normal and no dam had a litter consisting of only resorbed conceptuses. The maternal thyroid was identified as the target organ for ammonium perchlorate; increased incidences of thyroid follicular hypertrophy were observed in does treated with ≥10 mg/kg bw/d and significantly decreased T4 was observed in does treated with ≥30 mg/kg bw/d. A maternal NOAEL of 1.0 mg/kg bw/d was derived; in the absence of any effects, the developmental NOAEL was found to be 100 mg/kg bw/d.
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