Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 Unpublished report 20288971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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion