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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
20.01.- 30.03.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
yes
Remarks:
(see Results part)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Semi Dry Absorption (SDA) Product
- Molecular formula (if other than submission substance): not available
- Molecular weight (if other than submission substance): not available

Composition of test substance:
Calcium sulphate 6.49 %
Calcium sulphite 41.40 %
Calcium carbonate 29.50 %
Calcium hydroxide 2.27 %
Calcium chloride 17.98 %
Calcium fluoride 0.57 %
Oxides (SiO2 + Al2O3 + Fe2O3 + TiO2) sum 0.97 %
Sum of toxic metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn sum < 0.1 %

Batch No.: SDA/0609/Sk
Appearance: White solid powder
Stability / Expiration date: 15 years (06/2024)
- Stability under test conditions: stable
- Storage condition of test material: the substance was stored in PE container at room temperature.
- Other: pH 11 approx. (by contact of application form with universal indicator pH strip moistened with water, strip producer Lach-Ner, s.r.o. Neratovice)

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air

Results and discussion

Any other information on results incl. tables

Results

Due to its nature, it proved impossible to generate consistent, controllable and reliable atmospheres of the test material in its normal or ground state. It was, therefore, not possible to continue this study so as to expose animals to an atmosphere of the material suitable for an acute inhalation study.

Applicant's summary and conclusion

Interpretation of results:
other: not to be possible to generate a suitable test atmosphere from the test material
Conclusions:
The dust generation properties of Semi Dry Absorption (SDA) Product were shown to be low and mechanical systems designed to produce dust aerosols were unsuccessful in producing a dust atmosphere. It was, therefore, considered not to be possible to generate a suitable test atmosphere from the test material, for use in an inhalation study.
In view of the physical nature of the test material, its apparent low volatility and its apparent hygroscopic nature, it is considered unlikely to represent a significant hazard by the inhalation route.