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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
Aug 14-Aug 23 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
not specified
Type of method:
flask method

Test material

Specific details on test material used for the study:
Test item name: E stage 3 intermediate

Chemical name: 3-[(2R)-2-amino-2-phenylethyl]-5-(2-fluoro-3-methoxyphenyl)-1-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-6-methylpyrimidine-2,4(1H,3H)-dione 2-hydroxybenzoate (1:1)

CAS: 1821300-84-8

Purity: 97.4%

Batch no.: BO1801B009

Expiration date: 2019-02-05 (retest date)

Physical status: white powder

Storage conditions: Store at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
109.97 mg/L
Conc. based on:
test mat.
Incubation duration:
> 24 h
Temp.:
20 °C
pH:
5
Details on results:
The mean result of the water solubility of the test item was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).

Applicant's summary and conclusion

Conclusions:
The mean result of the water solubility of the test item was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).
Executive summary:

The water solubility of E stage 3 intermediate was determined compatible with the Principles of OECD Guidlines for testing of Chemicals No. 105 'Water Solubility'. Based on the test results, the water solubility was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).


 


The mean result of the water solubility of the test item was 109.97mg/L at 20°C, the RSD% was 0.28% (n=3).