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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 256-783-6 | CAS number: 50814-31-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: screening test, other
- Remarks:
- TOC removal
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Source study has reliability 2. Details on the read across are attached in section 13.
- Principles of method if other than guideline:
- Test method FC 2463 1.5.193
The determination of the test substance in the inlet and outlet of the treatment plant laboratory is based on the Total Organic Carbon (TOC) removal. - GLP compliance:
- not specified
- Duration of test (contact time):
- 31 d
- Initial conc.:
- 20 mg/L
- Based on:
- other: TOC
- Parameter followed for biodegradation estimation:
- TOC removal
- Parameter:
- % degradation (TOC removal)
- Value:
- 60
- Sampling time:
- 21 d
- Validity criteria fulfilled:
- not specified
- Conclusions:
- Test substance was tested according to method FC 2463 1.5.193.
In a 21-days evaluation period, degradation is 60%. - Executive summary:
Method
Degradation determined by following TOC removal according to test method FC 2463 1.5.193.
Results
In a 21 -days evaluated period, degradation based on TOC removal is 60 %.
- Endpoint:
- biodegradation in water: screening test, other
- Remarks:
- BOD5/COD
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliability 2. Details on the read across are attached in section 13.
- Principles of method if other than guideline:
- Determination of BOD5 and COD according to method DEV H5 and method DEV H4, respectively.
- GLP compliance:
- not specified
- Parameter:
- BOD5
- Value:
- 12 mg O2/g test mat.
- Parameter:
- COD
- Value:
- 617 mg O2/g test mat.
- Parameter:
- BOD5*100/COD
- Value:
- 2
- Remarks on result:
- other: the unit of measure is in percent
- Validity criteria fulfilled:
- not specified
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- Determination of BOD5 and COD according to method DEV H5 and method DEV H4, respectively.
BOD5 / COD = 2 % - Executive summary:
Method
Method DEV H5 and DEV H4 to determine BOD5 and COD.
Results
BOD5/COD = 2 %
- Endpoint:
- biodegradation in water: screening test, other
- Remarks:
- BOD5
- Type of information:
- other:
- Remarks:
- read across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- Source study has reliability 1. Details on the read across are attached in section 13.
- Qualifier:
- according to guideline
- Guideline:
- other: UNE-EN 1899(1998)
- Principles of method if other than guideline:
- - Concentration of test substance
- Method of O2-determination
- Evaluation of the results - GLP compliance:
- not specified
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- other: suspension of microorganisms from soil
- Details on inoculum:
- - Source of inoculum: soil microorganism
- Preparation of inoculum for exposure: 10 g of soil/100 ml water; agitation in 30 min and filtration.
- Water filtered: yes
- Type and size of filter used, if any: paper filter - Duration of test (contact time):
- 5 d
- Initial conc.:
- 400 mg/L
- Based on:
- test mat.
- Initial conc.:
- 800 mg/L
- Based on:
- test mat.
- Initial conc.:
- 1 200 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- Test conditions:
- temperature: 20 ± 2 °C
- measurement of O2: Oximeter CRISOB OXI-320
TEST SYSTEM
- number of culture flasks per concentration: 2
- measuring equipment: O2-consumption - Reference substance:
- other: glucose-glutamic acid
- Parameter:
- BOD5
- Value:
- 45.77 other: mgO2/g active substance
- Results with reference substance:
- BOD5 = 234 mgO2/l, which is within the acceptable range ( 210 ± 40 mg/l)
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The substance was tested according to the guideline UNE-EN 1899 (1998).
BOD5 = 45.77 mg O2/g active substance. - Executive summary:
Method
BOD5 determined according to UNE-EN 1899(1998).
Results
BOD5 = 45.77 mg O2/g active substance.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- other: read across from supporting substance (structural analouge or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Source study has reliability 1. Details on the read across are attached in section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 E (Ready biodegradability: Modified OECD Screening Test)
- GLP compliance:
- not specified
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, domestic, non-adapted
- Details on inoculum:
- 0.5 ml effluent of a domestic waste water treatment plant (with a secondary treatment).
- Duration of test (contact time):
- 28 d
- Initial conc.:
- 20 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- DOC removal
- Details on study design:
- Test conditions:
-Test temperature: 22 ± 1 °C
- Lighting: diffused light
Test system:
- Number of culture flasks/concentration: 2
Sampling
-Sampling frequency: at day 0, 1, 2, 3, 7, 9, 14, 16, 18, 21, 23, 25, 28
Control and blank system
-Inoculum blank: yes - Reference substance:
- acetic acid, sodium salt
- Parameter:
- % degradation (DOC removal)
- Value:
- 48
- Sampling time:
- 28 d
- Results with reference substance:
- Biodegradation corrected by control was 100% as DOC (mg/l) on day 28.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The substance was tested according to guideline OECD 301E.
Not readily biodegradable based on 48 % of degradation at day 28 in a ready biodegradability test according to OECD guideline 301 E. - Executive summary:
Method
The test was performed according to OECD guideline 301E. Degradation was followed in terms of DOC removal during the test period.
Results
On day 28, a 48 % degradation was found, based on DOC removal. As degradation was below the pass level criterion of 70 %, the substance was considered as not readily biodegradable.
Referenceopen allclose all
Description of key information
OECD 301E, DOC, not readily biodegradable.
UNE-EN 1899 (1998), BOD5, not readily biodegradable.
Method DEV H5 and method DEV H4, BOD5/COD, not readily biodegradable.
Method FC 2463 1.5.193, TOC, degradation is 60%.
Key value for chemical safety assessment
Additional information
No data on target substance was available, thus the biodegradability potential was assessed based on a read across approach, as detailed in section 13. Experimental data on Similar Substance 01 and Similar Substnace 02 was used.
Studies on biodegradation in water, BOD5 and COD were available. A study conducted to assess the ready biodegradability potential of Similar Substance 02 was selected as key study, as well detailed and conducted according to OECD guideline (OECD 301E). After 28 days, a 48 % of degradation based on DOC removal was seen. As the percentage of degradation was below the pass level criterion of 70 % for ready biodegradability based on DOC removal, the substance was considered as not readily biodegradable.
The other available studies gave supporting evidence of the not ready biodegradability of the substance.
Such data is consistent with the technical function of the substance, i.e. dye, for which ready biodegradability is not a desirable property.
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.
