Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Given the precision required (the solubility is determined as a range), no sufficient human error is expected which could lead to a non reliable result

Data source

Reference
Reference Type:
other company data
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
1) Tare a 100ml dried volumetric flask at a fixed temperature of 20°C
2) Fill in the flask with 100 mg of the substance (given the high solubility expected)
3) Add 10ml of water and check if the substance is solubilized
4) Repeat Step 3) until the substance is solubilized
=> solubility (mg/L) = 100000 / FinalVolume
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
> 10 000 mg/L
Temp.:
20 °C

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
very soluble (>10000 mg/L)