CDX-403

Auto flammability

Administrative data

Endpoint:

relative self-ignition temperature (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 a solid having a melting point <= 160°C

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Enzymes are proteins and do not possess the ability to ignite themselves. When heating the enzymes above the biological conditions, typically 80 °C and higher, the attracting forces within the enzymes are broken, the fold is disrupted and the enzyme denatures. Denatured the enzymes lose their activity.

A study following the guidelines of UN Test N.4 Test Method for Self-heating Substances (2015) demonstrated no spontaneous ignition and no exothermic effect [1]. After the experiment, the CDX-403 had turned into a brown residue indicating that the CDX-403 had decomposed and/or reacted during the experiment. The negative result obtained at 140 °C using a 10 cm sample cube concluded that CDX-403 is not a self-heating substance.

The results of the CDX-403 self-heating assessment demonstrated that the CDX-403 had decomposed and/or reacted during the experiment which further supports the justification for data waiving that enzymes are proteins and do not possess the ability to ignite themselves.

[1] Charles River Laboratories Den Bosch BV (2021). Determination of Physico-Chemical Properties of CDX-403: Flammability, Self-Heating Temperature. Unpublished report 20288971

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

self-heating substances / mixtures

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

7 June 2021 - 9 June 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.4 (Test method for self-heating substances)

Version / remarks:

Rev. 6 (2015)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Identification: CDX-403
Physical Description: Light brown powder
Storage Conditions: In freezer (≤ -15°C)

Key result

Test procedure:

100 mm sample cube at 140°C

Result:

negative outcome (no effect observed)

No spontaneous ignition occurred. No exothermic effect of the test item was observed. 

After the experiment the test item had turned into a brown residue. It indicated that the test item had decomposed and/or reacted during the experiment.

 

 

 

 

 

 

Interpretation of results:

other: not classified based on GHS or CLP criteria

Conclusions:

The substance is not a self-heating substance.

Executive summary:

In a GLP study according to UN Test N.4, a negative result was obtained using a 10 cm sample cube at 140°C. Based on this it was concluded that the test item is not a self-heating substance.