Registration Dossier

Physical & Chemical properties

Flammability

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

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:
flammability, other
Remarks:
Flammability of solids: Burning behaviour
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.
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

There is no spreading of fire (class 1: no ignition at 20 and at 100 deg C).

Interpretation of results:
non flammable
Conclusions:
The substance is not considered to be flammable since no ignition occurred at 20 deg C and at 100 deg C.
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 December 2015 - 25 April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Batch n°: I15FC2164
- Analytical purity: 102.2% (HPLC assay)
- Expiration date: 23 June 2017
- 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, burned with a blue orange flame, emitted sparks and turned into a black residue. Grey smoke was observed. After removal of the ignition source, the flame extinguished within 1 second and 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-4754724-AAA (T002488).

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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 December 2015 - 25 April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
UN Manual of Tests and Criteria: Test N.4 (Test method for self-heating substances)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Batch n°: I15FC2164
- Analytical purity: 102.2% (HPLC assay)
- Expiration date: 23 June 2017
- Storage condition: at room temperature
Key result
Test procedure:
100 mm sample cube at 140°C
Result:
negative outcome (no effect observed)

A negative result was obtained. No spontaneous ignition occurred and no exothermic effect of the test item was observed. It demonstrated that the test item is “not a self-heating substance”. According to the UN guideline, no further testing is required.

After the experiment, the test item had turned into a slightly yellow, powdery residue.

Interpretation of results:
not classified based on GHS criteria
Conclusions:
Based on the results of the UN N.4 test performed, the test item is considered ‘not self-heating’.

Description of key information

The flammability potential of T002488 was determined in a GLP study according to the UN N.1 Method (Klimisch 1, Reingruber, 2016).

According to the results of the preliminary test, performance of the burning rate test was not required. T002488 is considered as not readily combustible (i.e. not flammable). Furthermore, T002488 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, T002488 is not considered as a self-heating substance based on a UN N.4 test (Klimisch 1, Reingruber, 2016).

Key value for chemical safety assessment

Flammability:
not classified

Additional information

A supporting study is available performed by the Janssen Pharmaceutica Process Safety Center (2004). In this study no spreading of fire was observed and the burning class was determined to be class 1 (no ignition) at 20°C 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.