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Toxicological information

Acute Toxicity: oral

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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:
1979
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

Constituent 1
Reference substance name:
EDTMP-xCaxNa
IUPAC Name:
EDTMP-xCaxNa
Constituent 2
Chemical structure
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:
[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
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

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:
All animals appeared normal throughout the observation period.
Body weight:
All animals showed normal body weight gains at the end of 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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