[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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.

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:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

No necropsies were performed.

GLP compliance:

no

Test type:

other:

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

EDTMP-xCaxNa

IUPAC Name:

EDTMP-xCaxNa

Constituent 2

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: in a polythene screw capped container, 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 Limited
- Weight at study initiation: 150-250 g
- Housing: Animals were housed in a single air-conditioned room until dosing, which after they were placed in individual solid bottomed plastic cages for the duration of the 24 hour contact period. At the end of this period they were transferred to group boxes each containing 5 animals.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- Type of wrap if used: strip of aluminium foil was placed over the treated area on each animal and this was held in place using a strip of impermeable adhesive plaster which was wrapped around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg

VEHICLE
- Amount(s) applied (volume or weight with unit): A suspension of the test article was prepared in distilled water at a maximum applicable concentration of 5000 mg/kg

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

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 obseved for overt signs of toxicity or behavioural change at 1/4, 1, 2 and 4 hours after treatment. Individual body weights were recorded on the day of treatment and 14 days after.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the experiment.

Clinical signs:

other: All animals appeared normal throughout the observation period.

Gross pathology:

No necropsies were performed.

Other findings:

None reported.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

An acute dermal toxicity LD50 value of >5000 mg/kg was reported in a study carried out according to protocol comparable to current guideline, but not in compliance with GLP.