Registration Dossier
Registration Dossier
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EC number: 300-326-6 | CAS number: 93925-25-8
pH
Administrative data
- Endpoint:
- pH
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Between 17 October 2011 and 13 January 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Measurements in test media of studies under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Measurements of pH reported in several GLP-compliant guideline studies for different endpoints were used
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health of Government of the U.K., inspection 19-21 July 2011
Test material
- Reference substance name:
- Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.
- EC Number:
- 300-326-6
- EC Name:
- Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.
- Cas Number:
- 93925-25-8
- Molecular formula:
- Complex
- IUPAC Name:
- Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.
- Test material form:
- liquid: viscous
- Details on test material:
- - Substance type: Organic
- Physical state: White liquid
- Analytical purity: Considered to be 100 % due to the UVCB character
- Lot/batch No.: 0100823714
- Expiration date of the lot/batch: 28 September 2012
- Storage condition of test material: Room temperature, in the dark
- Other: Date received at the test laboratory: 28 September 2011
Constituent 1
Results and discussion
pH valueopen allclose all
- pH value:
- >= 7.29 - <= 7.33
- Temp.:
- 37 °C
- Concentration:
- >= 9.77 - <= 2 500 mg/L
- Remarks on result:
- other: Measured in the culture media of a mouse lymphoma assay, vehicle acetone 0.5 %
- pH value:
- 6.2
- Temp.:
- 20 °C
- Concentration:
- 110 other: mg/L loading rate WAF
- Remarks on result:
- other: WAF of double-distilled water (water solubility test) after 24 h shaking at 30 °C and 24 h standing; after 48 and 72 h shaking the pH decreased to 4.7 and 4.1, respectively; test item concentration < LOQ in all pH measurements
Applicant's summary and conclusion
- Conclusions:
- No pH-effect of the test item
- Executive summary:
From several GLP studies pH measurements in watery solutions of the test item are reported. Due to the water insolubility of the test item a vehicle was used or the pH of Water Accommodated Fractions were measured. The data suggest that the test item itself does not significantly influence the pH of watery solutions, while WAF of the test item tend to some acidity, which increases with time.
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