Registration Dossier

Administrative data

Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 03, 2007-October 05, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to EC and/or OECD guidelines and according to GLP principles.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.10 (Flammability (Solids))
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate
EC Number:
700-317-0
Cas Number:
934841-33-5
Molecular formula:
C30H49NO8
IUPAC Name:
tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate
Details on test material:
- Name of test material (as cited in study report): SPP100 C6
- Molecular formula: C30H49NO8
- Molecular weight: 551.73
- Substance type: white, fine-crystallic powder
- Physical state: solid
- Analytical purity: 99.2% (HPLC, sum of isomers 1 and 2)
- Impurities (identity and concentrations):
significant impurities: sum of all impurities by HPLC: 0.8%
- solvent content:
Isopropyl acetate: 1.9% (w/w)
Methylcyclohexane: 5.8% (w/w)
- Lot/batch No.: HH-853.35Kr
- Stability/Expiration date of the lot/batch: December 2007

findings of test facility:
Content of water: 0.20% w/w (volumetric Karl Fischer titration)

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

The melting of the test substance occurred very easily at the site of burner flame action. But the test substance does not ignite nor smoulder in the period of 2 minutes. After the flame had been put off, only that part of the sample, which was in contact with the flame, was changed.

Evaluation: The test substance does not ignite and propagate combustion neither by burning with flame nor by smouldering along 200 mm of the powder train within the 4-minute test period. Therefore, the test substance should not be considered as highly flammable and no further testing is required.

Applicant's summary and conclusion

Interpretation of results:
non flammable
Remarks:
Migrated information
Conclusions:
The test substance does not ignite and propagate combustion. SPP100 C6 should not be considered as highly flammable substance.