Registration Dossier
Registration Dossier
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EC number: 266-030-3 | CAS number: 65996-95-4 Substance obtained by acidulating phosphate rock with phosphoric acid. Normally characterized as containing 40% or more available phosphoric oxide (P2O5). Composed primarily of calcium phosphate.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- October 6 – 26, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, GLP-compliant, according to OECD 425 in rat. Purity test substance unknown.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- diammonium phosphate (DAP)
- IUPAC Name:
- diammonium phosphate (DAP)
- Reference substance name:
- Diammonium hydrogenorthophosphate
- EC Number:
- 231-987-8
- EC Name:
- Diammonium hydrogenorthophosphate
- Cas Number:
- 7783-28-0
- Molecular formula:
- H3N.1/2H3O4P
- IUPAC Name:
- diammonium hydrogen phosphate
- Details on test material:
- - Analytical purity: (P205) Available Phosphoric Acid – 46.86% and Total Nitrogen – 17.93%
- Stability under test conditions: expected to be stable under test conditions and duration of study
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Ace Animals, Inc., Boyertown, PA on September 19 and 26, 2000
- Age at study initiation: Young adult (9-11 weeks)
- Weight at study initiation: males 275 – 310 grams and females 195-230 grams
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in
the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 13 or 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature Range: 18-22ºC
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- An initial dose of 2000 mg of the test substance per kilogram of bodyweight was administered to one healthy female rat by oral gavage. Due to the
absence of mortality in this animal a second female received the same dose level. Following the completion of dosing and 100% survival in a total of
three females, a group of three males was tested (simultaneously) at the above dose level. Prior to use, the test substance was ground in a coffee mill and administered by gavage as a 70% w/w suspension in distilled water (preliminary solubility testing indicated that suspension in excess of 70% were too viscous to be administered properly). - Doses:
- 1 x 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to administration and again on Days 7 and 14 (termination) after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- No data
Results and discussion
- Preliminary study:
- no data
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived.
- Clinical signs:
- other: Animals appeared active and healthy throughout the study period.
- Gross pathology:
- FEMALES: All tissues/organs No gross abnormalities
MALES: All tissues/organs No gross abnormalities - Other findings:
- No data
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No signs of toxicity were observed. LD50 > 2000 mg/kg.
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