Registration Dossier

Administrative data

Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-05-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Determination has been run according to standardized method but without GLP compliance.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DIN EN 1262:2004
Deviations:
no
Principles of method if other than guideline:
The pH value of a test sample solution or dispersion is determined by potentiometric measurement with a glass/calomel electrode and a pH meter. The method is applicable to aqueous solutions containing anionic, cationic and non-ionic surface active agents, ampholytic surface
active agents and products in solution containing surface active agents.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C16-C22 primary alkylamine
- Substance type: primary fatty amine
- Physical state: solid
- Analytical purity: 98 % by titration
- Impurities (identity and concentrations): sec. and tertiary amines 2 % by titration

- Iodine value [I2/100g]: 3
- Lot/batch No.: DEG4923428
- Stability under test conditions: stable
- Storage condition of test material: room temperature, dry
- Other:
The substance tested is equivalent to the reference substance named C16-22-(even
numbered)-alkylamines

Results and discussion

pH valueopen allclose all
pH value:
11.5
Temp.:
20 °C
Concentration:
5 vol%
Remarks on result:
other: in ethanol/water 1:1
pH value:
11.1
Temp.:
20 °C
Concentration:
1 vol%
Remarks on result:
other: in ethanol/water 1:1

Any other information on results incl. tables

The test substance was first dissolved in ethanol. After addition of water precipitation took place. The resulting solutions were turbid (opaque) and highly viscous. The solution of 1 % test substance in ethanol/water was less viscous than the 5 % solution.

Applicant's summary and conclusion

Conclusions:
The pH is determined to 11.5 in a 5 w/w-% solution of the test substance in water/ethanol (50:50). Also, the pH is determined to 11.1 in a 1 w/w-% solution of the test substance in water/ethanol (50:50). The determination was performed at room temperature.
Executive summary:

The pH is determined to 11.5 in a 5 w/w-% solution of the test substance in water/ethanol (50:50). Also, the pH is determined to 11.1 in a 1 w/w-% solution of the test substance in water/ethanol (50:50). The determination was performed at room temperature.