Registration Dossier

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:
other: Internal non-GLP data (acceptable for physico-chemistry) from a producer. Method not indicated. Data were approved by Quality Assurance department.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
not indicated
GLP compliance:
no
Type of method:
other: not indicated

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Yeast extract Ohly(R) KAF or -KAT
- Physical state: KAF: liquid; KAT: powder
- Analytical purity/impurities: not applicable (UVCB)
- Lot/batch No.: EH 10-000332 for -KAF, ES 410906 for -KAT
- Expiration date of the lot/batch: not indicated
- Stability under test conditions: not indicated
- Storage condition of test material: not indicated

Results and discussion

Water solubilityopen allclose all
Water solubility:
30 other: %, not indicated if w/w, w/v or v/v
Temp.:
50 °C
pH:
5
Remarks on result:
other: for test item KAF (liquid)
Water solubility:
20 other: %, not indicated if w/w, w/v or v/v
Temp.:
50 °C
pH:
5.5
Remarks on result:
other: for test item KAT (powder)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L) at 50°C and pH 5.0 to 5.5
Executive summary:

For Yeast extract, the water solubility at 50°C pH 5.0 to 5.5 was 20% (as powder) to 30% (as liquid): highly water soluble.