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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
not specified
Principles of method if other than guideline:
Various amounts of CDX-403 are mixed with 5 mL of water. This was rotated at 30°C overnight to dissolve. This solution was centrifuges at 4000 rpm for 30 minutes and visually inspected for insoluble lyophilized enzyme powder. The highest concentration with no visual insoluable matter is reported as the solubility of CDX-403.
GLP compliance:
not specified
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
Halohydrin dehalogenase
Cas Number:
132421-41-1
IUPAC Name:
Halohydrin dehalogenase
Test material form:
solid
Details on test material:
Lot number PF 791
Specific details on test material used for the study:
(lot# PF 791)

Results and discussion

Water solubility
Key result
Water solubility:
655 other: mg/mL
Conc. based on:
test mat.
Incubation duration:
24 h
Temp.:
30 °C
Remarks on result:
other: there is no data availble on the pH
Details on results:
The highest concentration of CDX-403 in water is achieved at 655 mg/mL. At this concentration, the solution is in a gel-like state. Adding additional lyophilized powder into this solution will making mixing impossible. As a result, the CDX-403 solubility is reported as 655 mg/mL in water.

Any other information on results incl. tables

 


The final concentration of CDX-403 is calculated based on the amount of lyophilized powder added and the final volume of the solution (Table 1). The UV280nm absorbance of each solution is measured to confirm that the OD is within linear range (Figure 1, attached in illustrations).


Table 1. Final volume and amounds (mg) of CDX-403 in water (mL)


 


 

























































Weight of CDX-403 (mg)



Water (mL)



Total Volume (mL)



51.9



5.00



5.05



119.1



5.00



4.58



306.2



5.00



5.25



594.4



5.00



5.50



1002



5.00



5.80



2014



5.00



6.50



4000



5.00



8.00



6000



5.00



9.16



6000



5.00



9.61



Applicant's summary and conclusion

Conclusions:
The water solubility is 655 mg/mL in water.
Executive summary:

For solubility in water, various amounts of CDX-403 were mixed with 5 mL of water. Rotate at 30°C overnight to dissolve. Centrifuge 4000 rpm for 30 minutes and visually observe insoluble lyophilized enzyme powder. The highest concentration is reported as the solubility of CDX-403.


The highest concentration of CDX-403 in water was achieved at 655 mg/mL. At this concentration, the solution is in a gel-like state. Adding additional lyophilized powder into this solution will making mixing impossible. As a result, the CDX-403 solubility is reported as 655 mg/mL in water.