Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
other: OECD 301
Principles of method if other than guideline:
Data published on ready biodegradation studies (OECD 301) for 2-aminoethanol, neutral form of ethanolaminium cation.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Inoculum or test system:
not specified
Parameter:
other: Ready Biodegradability
Remarks on result:
other: Ready Biodegradable
Interpretation of results:
readily biodegradable
Conclusions:
Ethanolaminium cation is considered as ready biodegradable, based on results of several ready biodegradation studies (OECD 301) available for its neutral form 2-aminoethanol (CAS number: 141-43-5;SIDS INITIAL ASSESSMENT PROFILE, OECD 2013). In water at environmentally relevant pH 2-aminoethanol will exist as ethanolaminium cation.
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
other: OECD 301
Principles of method if other than guideline:
Data published on ready biodegradation studies (OECD 301) for Ciclopirox, neutral form of 6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion.
GLP compliance:
not specified
Remarks:
Data published. No detailed information about GLP compliance.
Inoculum or test system:
not specified
Parameter:
other: Ready Biodegradability
Remarks on result:
other: not ready biodegradable
Validity criteria fulfilled:
not specified
Interpretation of results:
not readily biodegradable
Conclusions:
6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as not ready biodegradable, based on the result of a ready biodegradation study (OECD 301) available for its neutral form Ciclopirox. Within the environmentally relevant pH range, a substantial fraction of 6-cyclohexyl-4-methyl-2-ox opyridin-2(1H)-olate anion will be in the neutral form (6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one (Ciclopirox); CAS 29342-05-0; pKa (estimated) =6.84 (ChemAxon)).

Description of key information

Since Ciclopirox olamine is an organic salt, it is expected to dissociate upon its release in the environment and to dissolve in water into 6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion and ethanolaminium cation. Because of this dissociation behaviour, the assessment of Ciclopirox olamine biodegradation in water was focused on dissociation products.

Ethanolaminium cation is considered as ready biodegradable, based on results of several ready biodegradation studies (OECD 301) available for its neutral form 2-aminoethanol (CAS number: 141-43-5). In water at environmentally relevant pH 2-aminoethanol will exist as ethanolaminium cation.

6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as not ready biodegradable, based on the result of a ready biodegradation study (OECD 301) available for its neutral form Ciclopirox. Within the environmentally relevant pH range, a substantial fraction of 6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion will be in the neutral form (6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one (Ciclopirox); CAS 29342-05-0; pKa (estimated) =6.84 (ChemAxon)).

Based on experimental data on biodegradation of its dissociation products, Ciclopirox olamine is regarded as not biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed

Additional information