Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 26, 2015 to March 06, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 104 (Vapour Pressure Curve)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method A.4 (Vapour Pressure)
Deviations:
no
GLP compliance:
not specified
Type of method:
dynamic method
Specific details on test material used for the study:
Batch no.: SEALS 211-104-06-01
Appearance: white, waxy solid
Key result
Temp.:
20 °C
Vapour pressure:
<= 9.6 Pa
Key result
Temp.:
50 °C
Vapour pressure:
<= 150 Pa

- The experimentally determined vapour pressure of the test substance at 20°C was not in the recommended range of 1 to 1000 mbar for DSC-measurements. Therefore, an estimation procedure in accordance with the test method OECD Guideline 104 was used. This method is applied for vapour pressures between 103 and 10-7mbar.

- The vapour pressure P for solids can be calculated using the an adapted equation for liquids.

 

Conclusions:
Under the study conditions, the vapour pressure of the test substance was determined to be ≤9.6 Pa at 20°C and ≤150 Pa at 50°C.
Executive summary:

A study was conducted to determine the vapour pressure of the test substance according to OECD Guideline 104 (Grain-Watson estimation) similar to the EU method A.4 (dynamic method). The practical test performance was based on the in-house test procedure VTA(S) 31X07001.01: ‘determination of the vapour pressure curve of solid and liquid substances by means of DSC’. Under the study conditions, the vapour pressure of the test substance was determined to be ≤9.6 Pa at 20°C and ≤150 Pa at 50°C (Kintrup, 2015).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion