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Physical & Chemical properties

Flammability

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Endpoint:
substances / mixtures which in contact with water emit flammable gases
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
pyrophoric solids
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied
other:
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2008
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
according to
Guideline:
other: VDI Guideline 2263 Part I Burning behaviour.
Qualifier:
according to
Guideline:
other: ESCIS Expert Commission for Safety in the Swiss Chemical Industry, Booklet I "Sicherheitstests fur Chemikalien".
GLP compliance:
no

Burning No. at 20°C = 2 (brief ignition, rapid extinction)

Burning No. at 100°C = 2 (brief ignition, rapid extinction)

Conclusions:
Burning number of T003063 at 20°C and at 100°C is 2, indicating brief ignition and rapid extinction.
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 September 2015 - 21 January 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: UN no. ST/SG/AC/Rev.5: Recommendations on the Transport of Dangerous Goods, Part III, Test N.1: "Test Method for Readily Combust
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Batch M14KB4863
Test item storage conditions: At room temperature
Stable under storage conditions until 10 November 2017 (retest date)
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

In contact with the flame of the gas burner the test item melted, emitted yellow sparks and turned into a brown residue. After removal of the ignition source, no propagation of combustion of the test item was observed.

According to the guidelines, performance of the burning rate test is not required. Based on the results obtained, the test item is considered ‘not readily combustible’ (i.e. ‘not flammable’).

Interpretation of results:
not classified based on GHS criteria
Conclusions:
The preliminary screening test was performed for the determination of the flammability of JNJ-39453193-AAA (T003063).

No propagation of combustion of the test item along 200 mm length of the pile within 2 minutes was observed. According to the guidelines, performance of the burning rate test is not required. Based on the results obtained, the test item is considered 'not readily combustible' (i.e. ‘not flammable’).
Endpoint:
self-heating substances / mixtures
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is completely molten at 160°C

Description of key information

The flammability potential of T003063 was determined in a GLP study according to the UN N.1 Method (Klimisch 1, Brekelmans, 2016).

According to the results of the preliminary test, performance of the burning rate test was not required. T003063 is considered as not readily combustible (i.e. not flammable). Further, T003063 is not considered a pyrophoric substance or a substance which emits flammable gases after contact with water (no tests performed, waiving based on theoretical assessment and experience in day-to-day handling and use). Finally, T003063 is not considered as a self-heating substance either (no test performed, waiving because the substance has a melting point well below 160°C).

Key value for chemical safety assessment

Flammability:
not classified

Additional information

A supporting study is available performed by the Janssen Pharmaceutica Process Safety Center (2008). In this study no spreading of fire was observed and the burning class was determined to be class 2 (brief ignition, rapid extinction) at 20 and at 100°C.

Justification for classification or non-classification

The substance does not need to be classified as flammable, self-heating, pyrophoric or as a substance which emits flammable gases in contact with water.