Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 241-922-5 | CAS number: 18015-76-4
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: inherent biodegradability
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Summary; test procedures are not documented and described, therefore information available do not permit an evaluation. Furthermore, details related to the tested substance composition are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not influence the characteristics related to the specific end-point
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 302 B (Inherent biodegradability: Zahn-Wellens/EMPA Test)
- GLP compliance:
- not specified
- Inoculum or test system:
- not specified
- Remarks on result:
- other: see results in the other sections
- Interpretation of results:
- other: no conclusion can be reached
- Conclusions:
- No conclusion can be reached: it is not specified if the value is referred to degradation or elimination by absorption.
- Executive summary:
Summary; test procedures are not documented and described, therefore there are no information available about the test method and test conditions. OECD 302B: 82 % bioelimination
Conclusion
No conclusion can be reached: it is not specified if the value is referred to degradation or elimination by absorption.
- Endpoint:
- biodegradation in water: inherent biodegradability
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Summary; test procedures are not documented and described, therefore information available do not permit an evaluation. Furthermore, details related to the tested substance composition are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not influence the characteristics related to the specific end-point
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 302 B (Inherent biodegradability: Zahn-Wellens/EMPA Test)
- GLP compliance:
- not specified
- Inoculum or test system:
- not specified
- Remarks on result:
- other: see results in the other sections
- Interpretation of results:
- other: no conclusion can be reached
- Conclusions:
- No conclusion can be reached: it is not specified if the value is referred to degradation or elimination by absorption.
- Executive summary:
Summary; test procedures are not documented and described, therefore there are no information available about the test method and test conditions. OECD 302B: 82 % bioelimination
Conclusion
No conclusion can be reached: it is not specified if the value is referred to degradation or elimination by absorption.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Summary; test procedures are not documented and described, therefore information available do not permit an evaluation. Furthermore, details related to the tested substance composition are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not influence the characteristics related to the specific end-point
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- GLP compliance:
- not specified
- Inoculum or test system:
- not specified
- Duration of test (contact time):
- 14 d
- Remarks on result:
- other: see results in the other sections
- Interpretation of results:
- other: expected to be not readily biodegradable.
- Conclusions:
- Substance is expected to be not readily biodegradable.
- Executive summary:
Summary; test procedures are not documented and described, therefore there are no information available about the test method and test conditions. OECD 301C elimination at 14 d: 0.3 %
Conclusion
Substance is expected to be not readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Summary; test procedures are not documented and described, therefore information available do not permit an evaluation. Furthermore, details related to the tested substance composition are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not influence the characteristics related to the specific end-point
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
- GLP compliance:
- not specified
- Inoculum or test system:
- not specified
- Duration of test (contact time):
- 14 d
- Remarks on result:
- other: see results in the other sections
- Interpretation of results:
- other: expected to be not readily biodegradable.
- Conclusions:
- Substance is expected to be not readily biodegradable.
- Executive summary:
Summary; test procedures are not documented and described, therefore there are no information available about the test method and test conditions. OECD 301C elimination at 14 d: 0.3 %
Conclusion
Substance is expected to be not readily biodegradable.
- Endpoint:
- biodegradation in water: screening test, other
- Remarks:
- calculation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Estimated data using calculation software EpiSuite 4.1, a screening-level tool
- Principles of method if other than guideline:
- The biodegradability potential has been investigated by BIOWIN estimation tool*, which calculates the probability that a chemical under aerobic conditions with mixed cultures of microorganisms will biodegrade rapidly or slowly.
- GLP compliance:
- no
- Remarks on result:
- other: see results in the other sections
- Interpretation of results:
- other: expected as not readily biodegradable.
- Conclusions:
- Expected as not readily biodegradable.
- Executive summary:
The biodegradability potential has been investigated by BIOWIN estimation tool*, which calculates the probability that a chemical under aerobic conditions with mixed cultures of microorganisms will biodegrade rapidly or slowly.
The training set for BIOWIN 1, 2, 3 (ultimate degradation time frame) and 4 (primary degradation timeframe) was based on the overall conclusions of a panel of USEPA experts for rapid or slow environmental degradation and based on various types of degradation information on the training set substances. Nevertheless also the BIOWIN 1, 2 and 3 model has been tested (validated) in literature for its predictability concerning not ready and ready biodegradability.
In general the freely available BIOWIN models may be used when predicting the ready biodegradability of chemicals BIOWIN1, 2, 3, 5 and 6.
*Biowin v.4.10 is an application contained in the EpiSuite 4.1, the suite of physical/chemical property and environmental fate estimation programs developed by the EPA’s Office of Pollution Prevention Toxics and Syracuse Research Corporation (SRC).
Conclusion
The substance is expected to be NOT ready biodegradable.
Referenceopen allclose all
OECD 302B: 82 % bioelimination
OECD 302B: 82 % bioelimination
Elimination at 14 d: 0.3 %
Elimination at 14 d: 0.3 %
Non-linear model prediction (BIOWIN 2): 0.0130; does not biodegrade fast.
Ultimate biodegradation timeframe prediction (BIOWIN 3): 1.9813 months
Biowin5 (MITI linear model): -0.3279
MITI non-linear model prediction (BIOWIN 6): 0.0005; does not biodegrade fast
Description of key information
Not readly biodegradable
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
Additional information
Under standard test conditions in DyStarColours Distribution GmbH reports (1998) Malachite Green is indicated as not readily biodegradable (0.3 %, 14 days, OECD 301C); these values are confirmed by EpiSuite prediction. A possible inherent biodegradation is indicated in DyStarColours Distribution GmbH reports (1998) where a value of 82 % 9 of degradation in Zahn-Wellens test is reported, however any detail is missing about time and testing conditions.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
