Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not indicated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and well documented

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Observation period of 7 days (instead of 14 days).

Principles of method if other than guideline:

Observation period of 7 days (instead of 14 days).

GLP compliance:

not specified

Test type:

traditional method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

EC Number:

266-442-3

EC Name:

Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Cas Number:

66669-53-2

Molecular formula:

C7H7Na4O9P

IUPAC Name:

tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Details on test material:

- Composition of test material, percentage of components: The test material is a 41.4% (w/w) solution of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate. It is a clear aqueous solution.
- Lot/batch No.: 1765

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Wistar-Albino
- Weight at study initiation: 160-180 g.
- Diet: Standard lab diet, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

water

Details on inhalation exposure:

- System of generating particulates/aerosols: Spray (aerosol) generated by dynamic inhalation apparatus.
- Brief description of analytical method used: A piece of cotton wool was applied with the sprayed test substance (as was inhaled by the rats). The sprayed cotton was dried in an oven (water elution) and weighed by a gravimetric method that gave the weight of the dried substance that was applied. The figure was divided to give a determination of mg test substance in cubic meters (m3) of air.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Remarks on duration:

no

Concentrations:

800, 1479, 1979 mg/m³ air

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs, haematological parameters

Statistics:

No data.

Results and discussion

Preliminary study:

A concentration of 1780 mg/m³ air, was applied for one hour to 10 male and female rats. No clinical symptoms were observed.

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

1 979 mg/m³ air (analytical)

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 979 mg/m³ air (analytical)

Exp. duration:

4 h

Mortality:

No mortality during the time of the study.

Clinical signs:

other: No clinical symptoms appeared during the time of the study.

Body weight:

No data.

Gross pathology:

No data.

Other findings:

Haematological parameters: Erythrocytes, leucocytes, haemoglobin, haematocryte counts. No significant difference was found in the haematological results before and after the test substance application.

Any other information on results incl. tables

No remarks.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Inhalation of the test substance in concentrations of less than / equal 1979 mg/m³ is harmless. No mortality occurred and no clinical and haematological effects were observed.

Executive summary:

Acute inhalation toxicity was determined for the test substance, tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate. Five male and female rats were exposed for 4 hours to the test substance in analysed concentrations of 800, 1479, 1979 mg/m³ air. After 7 days of observations, no mortality occurred, no clinical symptoms were observed and no significant difference was found in haematological parameters which were examined before and after exposure.

The LC50 can be estimated as >1979 mg/m³. 1979 mg/m³ was the highest concentration that could technically be achieved. Following the mentioned results, the tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is not to be classified as harmful via inhalation as at the highest achievable concentration (1979 mg/m³) no clinical symptoms were observed and no significant difference was found in haematological parameters which were examined before and after exposure.