Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
publication
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Principles of method if other than guideline:
Observation period of 7 days (instead of 14 days).
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
other: 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:
NA

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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
1 979 mg/m³ air (analytical)
Exp. duration:
4 h
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:
No clinical symptoms appeared during the time of the study.
Body weight:
NA
Gross pathology:
NA
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.