Registration Dossier

Administrative data

Endpoint:
chronic toxicity: inhalation
Data waiving:
other justification
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 June 06, 2012 to June 13, 2012
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
Qualifier:
according to
Guideline:
EPA OPPTS 830.7950 (Vapor Pressure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
effusion method: by loss of weight or by trapping vaporisate
Specific details on test material used for the study:
- Name of test material (as cited in study report): Trimethyloctadecyl ammonium chloride
- Physical state: White powder
- Lot/batch No.: DEG4147039
- Storage condition of test material: At room temperature in the dark
Key result
Temp.:
20 °C
Vapour pressure:
< 0 Pa
Remarks on result:
other: i.e., equivalent to <6.3E-09 mm Hg
Key result
Temp.:
25 °C
Vapour pressure:
< 0 Pa
Remarks on result:
other: i.e., equivalent to <2.2E-08 mm Hg

- After the experiment, a beige residue remained in the sample container (original colour: white). The change of the colour indicated a reaction and/or a decomposition of the test substance. This was also confirmed by the higher weight loss with higher amount of test substance used in the test.

- The weight loss of the test substance at 170°C, 180°C, 190°C and 200°C however, was lower than the weight loss of chrysene at the same temperatures. According to this, the vapour pressure of the test substance was determined to be lower than that of chrysene.

Conclusions:
Under the conditions of the study, the vapour pressure of the test substance was determined to be <8.4E-07 Pa (i.e., equivalent to <6.3E-09 mm Hg) at 20°C and <2.9E-06 Pa (i.e., equivalent to <2.2E-08 mm Hg) at 25°C.
Executive summary:

A study was conducted to determine the vapour pressure of the test substance according to OECD Guideline 104, EU Method A.4 and US EPA OPPTS 830.7950, in compliance with GLP. The experiment was performed using the isothermal thermogravimetric effusion method. An amount of 7.82 or 14.7 mg of the test substance was applied to the surface of a roughened glass plate as a homogeneous layer using a suspension of the test substance in n-hexane. The weight loss of the test substance was measured continuously as a function of time. After the experiment, a beige residue remained in the sample container. The change of the colour indicated reaction and/or decomposition of the test substance. This was also confirmed by the higher weight loss with higher amount of test substance used in the test. The weight loss of the test substance at 170 °C, 180 °C, 190 °C and 200 °C however, was lower than the weight loss of reference substance chrysene at the same temperatures. According to this, the vapour pressure of the test substance was determined to be lower than that of chrysene. Under the conditions of the study, the vapour pressure of the test substance was determined to be < 8.4E-07 Pa (i.e., equivalent to < 6.3E-09 mm Hg) at 20°C and < 2.9E-06 Pa (i.e., equivalent to <2.2E-08 mm Hg) at 25°C (Brekelmans, 2012).

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 10, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 830.6303 (Physical State)
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
Batch no.: DEG4147039
Purity: 99.2% (w/w)
Appearance: white solid (powder)
Physical state at 20°C and 1013 hPa:
solid
Key result
Form:
powder
Colour:
white
Substance type:
organic
Conclusions:
Under the study conditions, the test substance was a white powder (solid) at atmospheric pressure and 20ºC.
Executive summary:

A study was conducted to determine the appearance, physical state and colour of the test substance according to US EPA OPPTS 830.6303. Under the study conditions, the test substance was a white powder (solid) at atmospheric pressure and 20ºC (Börjesson, 2012).

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion