Potassium salts of [hexane-1,6-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid (4-7 K:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4.8.1982-18.8.1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

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 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[hexane-1,6-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt

EC Number:

260-362-2

EC Name:

[hexane-1,6-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt

Cas Number:

56744-47-9

Molecular formula:

C10H28N2O12P4.xNa

Test material form:

liquid

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 and Sons Ltd., Battlesbridge, Essex
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 104-118g (males), 86-108g (females)
- Fasting period before study: overnight and up to ca. 2 hours after dosing
- Housing: The rats were randomly allocated to cages within treatment groups. They were housed in groups of five in polypropylene cages with sawdust bedding.
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): Not controlled, but remained within a range of 65-75%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: 15ml/kg

Doses:

15 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. On subsequent days the animals were observed at least once. Mortalities and evidence of overt toxicity were recorded at each observation. 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, other: The macroscopic appearance of abnormal organs was recorded.

Statistics:

An assessment of the acute oral median lethal dose of the test material was made.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 15 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 4 875 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortalities occurred during the fourteen day observation period at a dose level of 15ml/kg test substance, which equates to 3.75 ml/kg active acid.

Clinical signs:

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

Gross pathology:

No macroscopic abnormalities were seen in any animal killed at day 14.

Other findings:

None reported.

Any other information on results incl. tables

LD50 >3.75 ml/kg (a.i.)

specific gravity 1.3

LD50 >4875 mg/kg

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of >15 ml/kg in rat was reported in a reliable study conducted according to an appropriate protocol and in compliance with GLP. The equivalent LD50 value for the active acid based on this value is >3.75 ml/kg, which is estimated to be equal to 4875 mg/kg active acid. The result is a read across from HMDTMP sodium salt (CAS 56744-47-9).