Registration Dossier

Administrative data

Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-09-29 to 2007-04-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to EU Method A.10 (Flammability (Solids)) without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.10 (Flammability (Solids))
Deviations:
no
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
: Certificate from the United Kingdom GLP Monitoring Authorities

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VRT-753136 hcl
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.4% w/w by High Performance Liquid Chromatography (HPLC)
- Impurities (identity and concentrations): individual unknown components were detected at 0.03 area%; isopropanol (residual solvent) at 300 ppm
- Composition of test material, percentage of components: not applicable
- Isomers composition: not applicable
- Purity test date: 2006-05-25
- Lot/batch No.: 25515
- Expiration date of the lot/batch: May 2008
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: no data

Results and discussion

Pyrophoric solids
Test procedure:
ignition time on contact with air
Remarks:
Ignition on contact with air refers to either Pyrophoric solids or Pyrophoric liquids depending on physical state (migrated information).
Remarks on result:
no ignition on contact with air (not further specified)
Remarks:
corresponding to 'no' in migrated source record.
Pyrophoric liquids
Test procedure:
ignition time on contact with air
Remarks:
Ignition on contact with air refers to either Pyrophoric solids or Pyrophoric liquids depending on physical state (migrated information).
Remarks on result:
no ignition on contact with air (not further specified)
Remarks:
corresponding to 'no' in migrated source record.

Any other information on results incl. tables

In a preliminary test, the test substance melted and burned with a yellow flame while in contact with the ignition source, but did not sustain combustion when the source was removed. There was no propagation along the powder train. No further testing was necessary.

Applicant's summary and conclusion

Conclusions:
In the preliminary test, the test substance burned in the presence of an ignition source but did not propagate along the powder train or sustain burning in the absence of the ignition source. Based on the results of the preliminary test, the test substance was considered not to be highly flammable and no further testing was necessary.
Executive summary:

Not applicable