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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3.8.1982 - 17.8.1982

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 402 (Acute Dermal 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 & Sons Ltd., Battlesbridge, Essex
- Age at study initiation: ca. 6-8 weeks
- Weight at study initiation: 235-260g (males), 212-231g (females)
- Housing: The rats were randomly allocated to cages within treatment groups. They were housed individually during the 24 hour exposure period and in groups of five for the remainder of the study 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 +/-3
- Humidity (%): 65-75%RH
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the trunk
- Type of wrap if used: The trunk of the rat was encircled with a strip of elastic adhesive bandage 7.5cm wide and 25-30cm long, backed with aluminium foil. The bandage was tightened sufficently to prevent the animal from wriggling free and wrapped round to form a double layer.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin and surrounding hair were sponged thoroughly with warm water and rinsed and dried using absorbent paper, after the removal of the bandage and foil.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10ml/kg
- Concentration (if solution): undiluted

Duration of exposure:

24 hours

Doses:

10ml/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: The animals were observed at 0.5, 1, 2, 3, 4 and 5 hours following dosing. On subsequent days 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 were recorded.

Statistics:

Using the mortality data, an assessment of the acute percutaneous 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:

>= 10 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 3 250 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortalities occurred during the fourteen day observation period.

Clinical signs:

other: No signs of reaction to treatment were observed in any animal throughout the observation period.

Gross pathology:

Autopsy of animals killed on day 14 did not reveal any macroscopic abnormalities.

Other findings:

None reported.

Any other information on results incl. tables

LD50 >2.5 ml/kg (a.i.)

specific gravity 1.3

LD50 >3250 mg/kg

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of >10 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 >2.5 ml/kg. The estimated LD50 for the active acid is therefore >3250 mg/kg. The result is read across from HMDTMP sodium salt (CAS 56744-47-9).