Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Sponsor's identification: Lanfa 2
Description: waxy solid
Product code: LD004670
Batch number: 371886
Storage conditions: room temperature

Results and discussion

Water solubility
Water solubility:
0.21 mg/L
Temp.:
20 °C
pH:
7
Details on results:
Water solubility was, as expected, low., falling within the range 0.1 and 0.4 mg/l expected for lanolin fatty acids

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of the test material has been determined to be 0.21 mg/l of solution at room temperature.
Executive summary:

Method

The determination was carried out using the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Conclusion

The water solubility of the test material has been determined to be 0.21 mg/l of solution at room temperature.