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 05 July 2017 to 06 July 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.4 (Vapour Pressure)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Version / remarks:
2006
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7950 (Vapor Pressure)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: isothermal thermogravimetry
Key result
Temp.:
25 °C
Vapour pressure:
0 Pa
Key result
Temp.:
20 °C
Vapour pressure:
0 Pa

Table: Results of the isothermal TGA analysis (test substance)

 

Experiment

Temperature
[°C]

Weight loss [µg/min]

vT [g/cm2/h]

log vT

log PT

PT
[Pa]

A

170

8.60725

1.03E-03

-2.99

1.22

17

 

180

12.7354

1.52E-03

-2.82

1.43

27

 

190

22.9053

2.73E-03

-2.56

1.75

57

B

170

7.81883

9.33E-03

-3.03

1.17

15

 

175

9.96265

1.19E-03

-2.92

1.30

20

 

180

13.5559

1.62E-03

-2.79

1.47

29

Weight loss curve of Experiment A: see picture below.

Conclusions:
Under the study conditions, the vapour pressure of the test substance was determined to be 3.8E-06 Pa at 20°C and 8.0E-06 Pa at 25°C.
Executive summary:

A stuyd was conducted to determine the vapour pressure of the test substance, Oleyl TMAC, using the isothermal thermogravimetric effusion method, according to EU Method A.4, OECD Guideline 104 and EPA Guideline OPPTS 830.7950, in compliance with GLP. A vapour pressure curve was constructed from duplicate measurements at temperatures between 170°C and 190°C. Under the study conditions, the vapour pressure of the substance at 25°C and at 20°C was determined by extrapolation to be 8.0E-06 Pa and 3.8E-06 Pa, respectively (Reingruber, 2017).

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 28, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 830.6303 (Physical State)
Deviations:
not specified
GLP compliance:
not specified
Specific details on test material used for the study:
Batch No.: Solvent free version of 1439581
Physical state at 20°C and 1013 hPa:
solid
Form:
other: solid - paste
Remarks:
slippery
Colour:
whiteyellowish
Substance type:
organic
Conclusions:
Under the study conditions, the test substance was is a whiteyellowish and slippery solid-paste intermediate.
Executive summary:

A study was conducted to determine the appearance / physical state / colour of the test substance, Oleyl TMAC, according to EPA OPPTS 830.6303 Guideline. The sample was analyzed at 20 ºC and atmospheric pressure. Under the study conditions, the test substance was is a white yellowish and slippery solid-paste intermediate (Wiman, 2016).

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion