Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 17, 2002 to February 05, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Deviations:
no
Principles of method if other than guideline:
Additional guideline: OECD 113 "Screening test for thermal stability and stability in air".
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: vapour pressure balance
Specific details on test material used for the study:
Purity: 98.2 (w/w) %
Water content: 1.08 (w/w) % (Karl-Fisher-titration)
White powdery solid
Temp.:
20 °C
Vapour pressure:
0 Pa
Key result
Temp.:
25 °C
Vapour pressure:
0 Pa
Key result
Temp.:
50 °C
Vapour pressure:
0 Pa

Thermal stability

The measurements showed two endothermic effects; the first in the temperature range of 30 - 85°C, and the second in the temperature range of 185 - 250°C.

Vapour pressure balance

The values for 20, 25, and 50°C were calculated, using Antoine constants (A: 6.52084, B: -4182.11, and C: 273.15).

Log (p/hPa) = A + B/(C + T(°C))

Conclusions:
Under the study conditions, the vapour pressure of the test substance was determined to be 1.8E-06, 3.1E-06 and 3.8E-05 Pa at 20, 25 and 50°C, respectively.
Executive summary:

A study was conducted to determine the vapour pressure of the test substance, C12-14 TMAC, according to OECD Guidelines 104 and 113, and EU Method A.4. The type of method was: "Effusion: Vapour pressure balance". Thermal stability was determined via DSC in a closed glass crucible at a heating rate of 3K/min under nitrogen. The purified test substance was filled into a furnace in the chamber from which the sample was evaporating. The temperature of the cell and of the test substance was controlled by a surrounding heater. The vapour formed a molecular jet of defined geometry limited by an orifice, which was then condensed on a plate cooled down below -100°C (with liquid nitrogen). The plate formed one end of an ultra micro balance. The pressure of the test substance was calculated from the weight increase during an elapsed time period. The values for 20, 25, and 50°C were calculated, using Antoine constants (A: 6.52084, B: -4182.11, and C: 273.15) and the equation: log (p/hPa) = A + B/(C + T(°C)). Under the study conditions, the vapour pressure was determined to be 1.8E-06, 3.1E-06 and 3.8E-05 Pa at 20, 25 and 50°C, respectively (Franke, 2002).

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
other: assessed based on test material information from another study report
Adequacy of study:
key study
Study period:
From February 15, 2002 to february 20, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Appearance based on observations from other testing endpoints conducted on this substance all at the same laboratory.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Appearance assessment based on the observations made during testing for other endpoints.
GLP compliance:
yes
Specific details on test material used for the study:
Purity: 98.2%
White, coarse grained substance
Physical state at 20°C and 1013 hPa:
solid
Substance type:
organic

White coarse grained substance.

Conclusions:
The purified form of the test substance appears as white coarse grained solid.
Executive summary:

The physical state and appearance of the test substance, C12 -14 TMAC, were visually observed during testing of other endpoint testing. The purified form of the test substance appears as white coarse grained solid (Schneider, 2002).

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion