Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Principles of method if other than guideline:
Deviation: For the time between the last sampling (2016-11-07) and the compliance of the sponsor to end the study with the determination
of the pH via pH-meter (2016-11-10) the temperature was not additionally monitored manually. This deviation is considered to have no impact on quality and integrity of the study.
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Test Item: Baccartol Crude
Sponsor: 2376504
Batch Number: VE00364716
Content: not applicable - complex mixture
Appearance: yellow viscous liquid
Expiry date: 2017-04-02
Reccomended storage: Keep container tightly closed in a dry and well-ventilated place at ambient temperature (10-30 °C) protected from light.

Results and discussion

Water solubilityopen allclose all
Water solubility:
94.1 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
100 mg/L
Temp.:
20 °C
pH:
5.9
Water solubility:
616 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
1 000 mg/L
Temp.:
20 °C
pH:
5.9

Applicant's summary and conclusion

Conclusions:
The test item content of BACCARTOL CRUDE, determined as the sum of the four main components in the saturated aqueous phases, was determined at 20 °C and pH 5.9 to be 94.1 ± 5.9 mg/L for an application dose of 100 mg/L, and 616 ± 11 mg/L for an application dose of 1000 mg/L, respectively.
At both application doses, the test item was not completely dissolved, undissolved material was observed at the end of the study.