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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- not relevant
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Details on test material:
- Aluminum Ammonium Superphosphate (Batch No. 38771-55-3), a white powder stored at room temp in a dark, dry, closed container.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- The rats were supplied by Harlan Laboratories UK Limited. On receipt the animals were randomly allocated to cages.
Acclimatisation period: At least 5 days. Animals were selected randomly and given a number unique within the study and identified by a number written on a cage card.
Age at the beginning of the study: 8-12 weeks. Bodyweights: +- 20% of the mean weight of any previously dosed animals.
With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
Temperature and relative humidity: 19-25°C and 30-70% respectively.
Rate of air exchange: At least 15 changes per hours.
Lighting: 12h continuous light & 12h darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each individual animal to confirm the outcome of the previously dosed animals. The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days.
Bodyweights were recorded prior to dosing and seven and fourteen days after treatment. - Doses:
- 175 mg/kg, 550 mg/kg, 2000 mg/kg
- No. of animals per sex per dose:
- 5 females total:
1 female per the smaller dose of 175 mg/kg
1 female per 550 mg/kg
3 females per the higher concentration of 2000 mg/kg - Control animals:
- no
- Details on study design:
- For the purpose of the study the test material was freshly prepared, as a suspension at the appropriate concentration in distilled water. The test material was formulated within 2 hours of being applied to test system. It was assumed that the formulation was stable for this duration.
No information was available regarding the toxicity of the test material therefore the default values for LD50 and sigma were entered into AOT425 Statistical Program. The program gave a recommended dose progression of 2000, 550, 175, 55, 17.5, 5.5 and 1.75 mg/kg.
The first animal was dosed at 175 mg/kg. Further animals were then treated based on the short-term results of the previously treated animal. The test was complete after the fifth animal had been dosed as the following criterion was met: - three consecutive animals survived at the maximum dose level (2000 mg/kg).
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
The oral LD50 was calculated by maximum likelihood method. Data evaluations also included the relationship, if any, between the exposure of the animal to the test material and the incidence and severity of all abnormalities including behavioral and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Results and discussion
- Preliminary study:
- No
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Hunched posture was noted in all animals. Tiptoe gait was also noted in one animal treated at a dose level of 550 mg/kg. All animals appeared normal one day after dosing.
- Gross pathology:
- No abnormalities were noted at necroscopy.
- Other findings:
- no further information
Any other information on results incl. tables
no further information
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Wistar strain rat. 5 females were dosed at dose levels ongoing from 175 mg/kg bw to 2000 mg/kg bw. No deaths occurred and no abnormalities were noted. LD50 was found to be greater than 2000 mg/kg bodyweight.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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