Registration Dossier

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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Reason / purpose:
data waiving: supporting information
Remarks:
DSC
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2017-02-02 (experimental phase)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
n/a
Deviations:
not applicable
Qualifier:
according to
Guideline:
other: DIN 51007, ASTM D 3418-99
Deviations:
no
Principles of method if other than guideline:
Melting point was determined by DSC.
GLP compliance:
no
Type of method:
differential scanning calorimetry
Key result
Melting / freezing pt.:
175.2 °C
Decomposition:
yes
Decomp. temp.:
ca. 189 °C
Conclusions:
The study was performed according to ASTM D 3418-99 on the substance to be registered itself, the test procedure is well documented and therefore reliability of Klimisch 2 has been assigned. Melting point was determined as 175.2°C, decomposition occurred at ca. 189°C.
Executive summary:

The melting point of the test substance has been determined to be 175.2°C, decomposition occurred at ca. 189°C, by using differential scanning calorimetry (DSC) in a non-GLP study according to ASTM D 3418 -99.

Reason / purpose:
data waiving: supporting information
Remarks:
TGA
Reference
Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2017-02-02 (experimental phase)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: DIN 51005 & 51006
Deviations:
no
Principles of method if other than guideline:
Melting / boiling point was aimed to be determined by TGA.
GLP compliance:
no
Type of method:
differential thermal analysis
Key result
Decomposition:
yes
Decomp. temp.:
162.7
Remarks on result:
not determinable
Remarks:
At 162.7 °C the sample starts to decompose until only 0.67% of the initial mass remains at approx. 950 °C.
Conclusions:
The study was performed according to DIN 51005 & 51006 on the substance to be registered itself, the test procedure is well documented and therefore reliability of Klimisch 2 has been assigned. At 162.7 °C the sample starts to decompose until only 0.67% of the initial mass remains at approx. 950 °C.
Executive summary:

The boiling point of the test substance was aimed to be determined thermogravimetric analysis in a non-GLP study according to DIN 51005 & 51006. At 162.7 °C the sample starts to decompose until only 0.67% of the initial mass remains at approx. 950 °C.

Reason / purpose:
data waiving: supporting information
Remarks:
Flammability testing
Reference
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.10 (Flammability (Solids))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was tested as received. No further preliminary treatment such as drying or milling was performed. The results given in this report only apply to the tested sample.
Key result
Test procedure:
burning rate test: preliminary screening test
Remarks on result:
substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period
Interpretation of results:
GHS criteria not met
Conclusions:
The flammability was determined according to a scientifically valid method (EU method A.10) under GLP, in a well-documented study, hence, the following result for the test material can be considered as reliable:
The test item is not a highly flammable solid in the sense of the European Commission Regulation (EC) No. 440/2008, Method A.10.
No observations were made which might cause doubts concerning the validity of the study outcome.
The substance does not need to be classified as flammable solid.
Executive summary:

The flammability of the test item was determined following EU-Method A.10 under GLP.

In the preliminary screening test following the EU method, the burning behaviour over a distance of 200 mm is measured. One end of the pile is ignited. The test item could not be ignited with a flame, the test item melted and hence, the performance of the main test was not necessary.

Therefore, the test item should be considered as not-highly flammable solid (for EU regulations).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion