Registration Dossier
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EC number: 242-768-1 | CAS number: 19035-79-1
Dissociation constant
Administrative data
Link to relevant study record(s)
- Endpoint:
- dissociation constant
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2012-06-27 to 2012-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 112 (Dissociation Constants in Water)
- Version / remarks:
- adopted 1981-05-12
- Deviations:
- yes
- Remarks:
- Based on the low water solubility the test was performed at 60 % of the saturation concentration (at 120 mg/L).
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7370 (Dissociation constants in water)
- Version / remarks:
- of August 1996
- Deviations:
- yes
- Remarks:
- Based on the low water solubility the test was performed at 60 % of the saturation concentration (at 120 mg/L).
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Institut für Biologische Analytik und Consulting IBACON GmbH Arheilger Weg 17 64380 Rossdorf Germany
- Dissociating properties:
- ambiguous
- Conclusions:
- No dissociation constant could be determined.
- Executive summary:
A study was conducted according to OECD TG 112 to determine the dissociation constant of the test item in water using the titration method. Due to the low water solubility in deviation to the guideline the titration was performed at a concentration of 60 % of the saturation concentration (at 120 mg/L) of the test item in water. A titration with NaOH and with HCl at concentration of 0.01 M was performed. Both titration curves showed no equivalent point and they are nearly identical to water. Thus, no dissociation constant could be established.
- Endpoint:
- dissociation constant
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the analytical method is not sensitive enough
Referenceopen allclose all
Description of key information
No dissociation constant could be determined.
Key value for chemical safety assessment
Additional information
Waiver
In accordance with section 1 of REACH Annex XI, the dissociation constant study could not be conducted as the substance is poorly soluble in water. In addition a study according to OECD TG 112 was performed. Due to the low solubility in water it was not possible to generate a test item concentration which does not exceed the lesser of 0.01 M. Using a test item concentration of 120 mg/L corresponding to 0.00033 mol/L (60 % of the saturation concentration) the study was performed. Due to the low sensitivity of the titration method no dissociation constant could be established as the titration curves for the test item and water were nearly identical. The pre-test for genotoxicity (see IUCLID section 13) shows that no suitable solubility promoters could be established.
In conclusion it was technically not possible to determine the dissociation constant of the test item.
Study
A study was conducted according to OECD TG 112 to determine the dissociation constant of the test item in water using the titration method. Due to the low water solubility in deviation to the guideline the titration was performed at a concentration of 60 % of the saturation concentration (at 120 mg/L) of the test item in water. A titration with NaOH and with HCl at concentration of 0.01 M was performed. Both titration curves showed no equivalent point and they are nearly identical to water. Thus, no dissociation constant could be estimated.
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