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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20.8.1992-3.9.1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a protocol which was comparable to an appropriate OECD guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

EDTMP-xNa

IUPAC Name:

EDTMP-xNa

Constituent 2

Reference substance name:

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

EC Number:

244-742-5

EC Name:

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

Cas Number:

22036-77-7

Molecular formula:

C6H20N2O12P4.xNa

IUPAC Name:

x sodium (8-x) hydrogen {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)

Details on test material:

- Name of test material (as cited in study report): Briquest 422-25S

- Physical state: Straw coloured liquid

- Storage condition of test material: ambient temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. tuck & Sons Ltd., Battlesbridge, Essex
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 102-112g (males), 106-118g (females)
- Fasting period before study: overnight, and for two hours after test article administration
- Housing: the rats were randomly allocated to cages within treatment groups. They were housed in groups of 5 in polypropylene cages with sawdust bedding.
- Diet: standard laboratory rodent diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 65-72 %RH
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

10 ml/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: Animals were observed 0.5, 1, 2, 3, 4 and 5 hours following dosing, and on subsequent days at least once. Mortalities and evidence of overt toxicity were recorded at each observation. In addition, individual bodyweights were recorded on days 0, 7 and 14.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight, organ weights, histopathology. In addition, all animals were subjected to macroscopic posmortem examination, in which appearance of abnormal organs was recorded.

Statistics:

Using the mortality data obtained an assessement of the acute oral median lethal dose of the test material was made.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 250 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: calculated with specific gravity 1.3, 25% acid content

Mortality:

There were no mortalities.

Clinical signs:

other: Signs of reaction to treatment observed shortly after dosing in all rats consisted of pilo-erection, an abnormal body carriage (hunched posture), lethargy, decreased respiratory rate. Recovery of the rats as judged by external appearance and behaviour was

Gross pathology:

Autopsy of rats killed on Day 14 did not reveal any macroscopic abnormalities.

Other findings:

None reported.

Any other information on results incl. tables

The test material Briquest 422 - 25S comprises of 25% active acid. Because the results are reported in ml/kg, the specific gravity (1.3 -1.36) was used to calculate the LD50 in terms of active acid in mg/kg.

10/4=2.5 ml/kg

2.5 ml/kg x 1.3 g/ml =3250mg/kg active acid

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

An acute oral LD50 value of >10m ml/kg was reported in a study conducted according to an appropriate protocol and in compliance with GLP.