cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride

Explosiveness

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

explosive properties of explosives

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The test is performed according to EC guideline with some small deviations. However, there is no information on purity of the substance.

Qualifier:

according to guideline

Guideline:

EU Method A.14 (Explosive properties)

Deviations:

yes

Remarks:

1)The weight of the falling hammer is 5 kg and dropped from 0.8 m, however, the energy applied is the same as guideline, 40 J or 40 Nm. 2) In contrast to the EC guideline aluminium foil is used to pack the substance. 3) Ten tests are performed.

GLP compliance:

not specified

Parameter:

other: More sensitive to shock than m-dinitrobenzene

Remarks on result:

negative (not further specified)

Remarks:

If all tests according to Lütolf method are negative, powder can be considered not shock sensitive as reference substance meta-dinitrobenzene is not shock sensitive in similar conditions (although not tested simultaneously in this study)

Results:

-10 times negative, not shock sensitive (sensitivity > 39.2 Nm)

Interpretation of results:

non explosive

Conclusions:

The test substance is not shock sensitive.

Reference 2

Endpoint:

explosive properties of explosives

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with explosive properties

Reference 3

Endpoint:

explosive properties of explosives

Type of information:

other: Expert statement

Adequacy of study:

supporting study

Study period:

24 August 2015 - 25 August 2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Expert statement following no specific guideline and without detailed description of results.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Expert statement.

GLP compliance:

no

Specific details on test material used for the study:

- Batch n°: I14KB4717
- Analytical purity: 105.7% (acid titration)
- Expiration date: 25 November 2016
- Storage condition: at room temperature

None of the components of the test item does contain chemical groups which are associated with explosive properties. The molecular structures of any impurities =<1% were not taken into account. In conclusion, JNJ-17336007-AAC (T001202) has no explosive properties.

Interpretation of results:

GHS criteria not met

Conclusions:

It is concluded that the substance T001202 does not have explosive properties.

Description of key information

Based on an expert statement (Ciric, 2017), the substance is considered not explosive because it does not contain any structural groups that are indicative of explosive properties.

Key value for chemical safety assessment

Explosiveness:

non explosive

Additional information

A supporting study (Klimisch 4, Janssen Pharmaceutica Process Safety Center, 1990) is available, indicating that T001202 is not sensitive to impact (shock sensitivity > 39.2 Nm). These results support the conclusion that the substance is not explosive based on the absence of structural groups that are indicative of explosive properties.

Justification for classification or non-classification

T001202 should not be considered explosive based on the absence of structural groups that are indicative of explosive properties. This is also confirmed by the results of a falling hammer test (Lütolf) indicating that the substance is not sensitive to impact (shock sensitivity > 39.2 Nm).