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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:
the study does not need to be conducted because the experience in production or handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water
other:
Endpoint:
pyrophoric solids
Data waiving:
other justification
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:
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
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Although the study was not performed according to an OECD or EC guideline, the used methodology is adequate and sufficient to conclude on the 'flammability solids' endpoint. However, no information on purity of the substance is reported.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: VDI Guideline 2263 Part 1, Burning behaviour: Test Methods for the Determination of the Safety Characteristic of Dusts (May 1990)
Deviations:
no
Qualifier:
according to
Guideline:
other: ESCIS Expert Commission for Safety in the Swiss Chemical Industry, Booklet 1 ”Sicherheitstests fur Chemikalien" (1998)
Deviations:
yes
Remarks:
30 min conditioning instead of 1 hour
GLP compliance:
not specified
Test material information:
Composition 1

There is no spreading of fire (class 2: brief ignition, rapid extinction at 20 and at 100 deg C).

Interpretation of results:
GHS criteria not met
Conclusions:
There is no spreading of fire (class 2: brief ignition, rapid extinction at 20 and at 100 °C).
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 September -15 December 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
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 (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
- Batch n°: M14IB5308
- Analytical purity: >= 99.7%
- Expiration date: 03 February 2016
- Storage condition: at room temperature
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-16479489-AAA (T001159).
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’).

Description of key information

During the GLP preliminary study according to the UN N.1 method (K1, Reingruber, 2016) no propagation of combustion was observed which implied that no full-scale burning test was required and T001159 is considered 'not readily combustible' (i.e. 'not flammable').

Furthermore, T001159 is not considered a pyrophoric or self-heating substance or a substance which emits flammable gases after contact with water (no tests performed, waiving).

Key value for chemical safety assessment

Flammability:
not classified

Additional information

In a supporting study (assigned K4) performed by the Janssen Pharmaceutica Process Safety Center (1984) the burning class was determined to be class 2 (brief ignition, rapid extinction) at 20°C and at 100°C.

Justification for classification or non-classification

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