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

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:

other: The study was conducted according to a protocol similar to the current 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 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:

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 (ethylene diamine tetra methylene phosphonic acid-sodium salt)

- Physical state: straw coloured liquid

- Storage condition of test material: in a screw top plastic container, at 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: ca. 6-8 weeks
- Weight at study initiation: 216-255g
- Fasting period before study: 210-232g
- Housing: individually housed during the 24 hour exposure period, and in groups of 5 for the remainder of the study in polypropylene cages with sawdust beding
- Diet: standard laboratory 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): ca.15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk of the rat
- Type of wrap if used: elastic adhesive bandage, backed with aluminium foil

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

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

Duration of exposure:

24h

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. On subsequent days, the animals were observed at least once. Mortalities and evident toxicity were recorded at each observation. Individual body weights 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:

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

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 from reported value

Mortality:

There were no mortalities.

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

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:

The acute dermal LD50 value of >10 ml/kg was reported in a study conducted according to a protocol similar to current guideline and in compliance with GLP. The specific gravity was used to calculate the LD50 value in units comparable to current CLP, which derived the value of >3250 mg/kg.