6-fluoro-3-(piperidin-4-yl)-1,2-benzoxazole hydrochloride

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Administrative data

Endpoint:

relative self-ignition temperature (solids)

Remarks:

Self-heating temperature

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 May 2017 - 15 September 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.16 (Relative Self-Ignition Temperature for Solids)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: United Nations (UN), UN no. ST/SG/AC.10/11/Rev.6

Version / remarks:

United Nations (UN), UN no. ST/SG/AC.10/11/Rev.6: Recommendations on the Transport of
Dangerous Goods, Part III: Classification Procedures, Test Methods and Criteria Relating to
Class 2, Class 3, Class 4, Division 5.1, Class 8 and Class 9, Test N.4: “Test Method for Selfheating
Substances”, 2015.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

6-FLUORO-3-(PIPERIDIN-4-YL)-1,2-BENZOXAZOLE HYDROCHLORIDE

EC Number:

700-303-4

Cas Number:

84163-13-3

Molecular formula:

C12H13FN2O.HCl

IUPAC Name:

6-FLUORO-3-(PIPERIDIN-4-YL)-1,2-BENZOXAZOLE HYDROCHLORIDE

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Batch n°: I16EC2452
- Analytical purity: 100.2% (based on assay; calculated on anhydrous basis)
- Expiration date: 22 November 2020 (retest date)
- Storage condition: at room temperature

Results and discussion

Relative self-ignition temperature (solids)

Remarks on result:

no self ignition observed under the test conditions

Any other information on results incl. tables

Preliminary test according to EC A.16

An exothermic effect of the test item was observed. The temperature of the test item reached 400°C at an oven temperature of 383°C. It demonstrated that the self-ignition temperature of the test item is 383°C. After the experiment, the test item had turned into a black, expanded residue and was collected in a container that was placed below the cube. It indicated that the test item had decomposed and/or reacted during the experiment. As the preliminary test was positive a main study according to UN N.4 was performed.

Main study according to UN N.4

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 consistency of the sample was unchanged, i.e. no reaction and/or decomposition of the test item was observed.

Applicant's summary and conclusion

Conclusions:

Self-heating of JNJ-1782820-AAC (T001492) was determined in accordance with UN Test N.4 “Test Method for Self-heating Substances”. From the negative result obtained at 140°C using a 10 cm sample cube, it was concluded that
JNJ-1782820-AAC (T001492) is not a self-heating substance.