Registration Dossier
Registration Dossier
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EC number: 239-590-1 | CAS number: 15541-60-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 December 2003 to 5 January 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with an internationally recognised method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- EC Number:
- 239-590-1
- EC Name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Cas Number:
- 15541-60-3
- Molecular formula:
- C3H6N6.xH4O7P2
- IUPAC Name:
- diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): MPP
- Appearance: white powder
- Analytical purity: not stated
- Lot/batch No.: 101Z3U
- Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: reputable supplier of laboratory animals
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 196-206g
- Fasting period: overnight (prior to dosing), 3-4 hours after dosing
- Housing: in groups of three in suspended solid-floor polypropylene cages furnished with wood flakes
- Diet: certified rat and mouse diet, ad libitum.
- Water: mains drinking water, ad libitum:
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 8 December 2003 To: 10 December 2003
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: produced suspension suitable for dosing
MAXIMUM DOSE VOLUME APPLIED: 10 ml
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: consideration of all available toxicity information 2000 mg/kg was chosen as the starting dose
Determination by analysis of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not specified in the Study Plan and is not a requirement of the Test Guideline. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing
and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after
treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- 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 Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.
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