Sol-gel reaction products of alcohols, hydrochloric acid, pentane-2,4-dione, zirconium tetraalkanolate and water

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

>= 1 - <= 4 µm

Geometric standard deviation (GSD):

>= 1.5 - <= 3

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

3.96 mg/L

No. of animals per sex per dose:

3 rats/sex/dose

Control animals:

no

Statistics:

LC50 Value: The inhalation LC50 value could not be estimated as there was no mortality observed at the maximum attainable concentration.
MMAD: The measurements of the aerosol particle size were analysed under the assumption of a log normal size distribution. The Mass Median Aerodynamic Diameter (MMAD) was estimated by the Probit Least Square Method.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 3.96 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

All treated rats survived throughout the observation period of 14 days post exposure.

Clinical signs:

other: Reversible signs of nasal discharge, tremors, hypoactivity and ruffled appearance were observed in exposed rats. Animals became free of these signs on day 2 after exposure.

Body weight:

The test item did not have any adverse effect on the body weight gain by of the exposed male and female rats throughout the observation period.

Gross pathology:

The test item did not induce any gross pathological alterations in any of the rats, as evidenced during their necropsy at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

other: The test item W3803S04SOLSIV is anticipated to belong either to GHS Category 4 or GHS Category 5.

Conclusions:

Based on these results, and according to Globally Harmonized System (GHS) for classification of chemicals which cause acute toxicity Seventh Revised Edition (ST/SG/AC.10/30/Rev.7); United Nations, New York and Geneva, 2017; eISBN 978-92-1-060457-4 and the EC Requirements for Classification and Labelling of Dangerous Substances (Commission Directive 2001/59/EC of 6th August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the Classification, Packaging and Labelling of Dangerous Substances, the test item W3803S04SOLSIV is anticipated to belong either to GHS Category 4 or GHS Category 5.