Registration Dossier
Registration Dossier
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EC number: 287-370-9 | CAS number: 85480-89-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October - November 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a protocol which was similar to current guideline, but not compliant with GLP. No necropsies were carried out.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 401
- Principles of method if other than guideline:
- No necropsy of surviving animals was carried out.
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- EDTMP-xCaxNa
- IUPAC Name:
- EDTMP-xCaxNa
- Reference substance name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
- EC Number:
- 287-370-9
- EC Name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
- Cas Number:
- 85480-89-3
- Molecular formula:
- C6H20-2x-yN2O12P4.xCa.yNa
- IUPAC Name:
- x calcium y sodium {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)
- Details on test material:
- - Name of test material (as cited in study report): Mixed calcium and sodium salts of ethylenediamine tetra (methylene phosphonic acid) - solid form
- Physical state: white powder
- Storage condition of test material: supplied in a polythene screw capped container, stored at room temperature in the dark
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: Bantin and Kingman Ltd., Grimston, Aldbrough, Nr. Hull
- Weight at study initiation: 150-250g
- Fasting period before study: over night
- Housing: Animals were caged in groups of 2 or 5 as appropriate in solid- bottomed plastic cages furnished with softwood sawdust.
- Diet: With the exception of overnight fast for 18-20 hours before treatment, the animals were allowed food, ad libitum
- Water: ad libitum
- Acclimation period: no more than 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): room was air-conditioned
- Photoperiod (hrs light): 08.45-17.00
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
Suspensions of the test article were prepared in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 250, 500, 1000, 2000, 5000 mg/kg
- No. of animals per sex per dose:
- Four groups of 4 rats (3M, 2F) and 1 group of 10 rats (5M, 5F)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for overt signs of toxicity or behavioural change at 1/4, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days. All observations were recorded. Individual body weights were recorded on the day before treatment, on the day of treatment and 14 days after treatment.
- Necropsy of survivors performed: no
Results and discussion
- Preliminary study:
- No animals dies during the 48 hour period following the dose range-finding study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- dissolved
- Remarks:
- test material
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: All animals appeared normal throughout the observation period.
- Gross pathology:
- No necropsies were performed as there were no test material related deaths.
- Other findings:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- An acute oral LD50 value of >5000 mg/kg was reported in a report which was carried out according to a protocol similar to current guideline. The study was not GLP compliant and no necropsy of surviving animals was carried out.
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