Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 224-546-6 | CAS number: 4403-90-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Remarks:
- prediction
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2023
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- QSAR estimation
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- QSAR dyes R&C report produced by version QSAR dyes RC 2.0 Developed by Milano Chemometrics and QASR research group Dept. Earth and Environmental Science, University Milano Bicocca, Italy.
- GLP compliance:
- no
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks on result:
- not readily biodegradable based on QSAR/QSPR prediction
- Validity criteria fulfilled:
- not applicable
- Remarks:
- estimation by prediction tool
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- QSAR Prediction - the substance resulted as not readily biodegradable.
- Executive summary:
The substance resulted not readily biodegradable based on similarities, physical-chemical properties and dyes chemistry.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- other: Expert Judgement
- Adequacy of study:
- key study
- Study period:
- 2023
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Expert Judgement
- GLP compliance:
- no
- Inoculum or test system:
- other: not applicable
- Parameter followed for biodegradation estimation:
- other: Expert Judgement
- Parameter:
- other: Ready Biodegradability based on Expert Judgement
- Remarks on result:
- other: not readily biodegradable based on expert judgement
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- not readily biodegradable based on an expert judgement.
- Executive summary:
Not readily biodegradable based on an expert judgement.
- Endpoint:
- biodegradation in water: screening tests
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- April 02, 1974
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Internal Method DEV 4 and DEV 5.
No more data available - GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- not specified
- Duration of test (contact time):
- ca. 5 d
- Initial conc.:
- ca. 42 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Parameter:
- BOD5
- Value:
- ca. 39 mg O2/g test mat.
- Parameter:
- COD
- Value:
- ca. 1 180 mg O2/g test mat.
- Parameter:
- BOD5*100/COD
- Value:
- 3
- Validity criteria fulfilled:
- not applicable
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The test substance was tested for the determination of the BOD5/COD ratio following the internal methods Nr. 16 and Nr. 15. Under the experimental conditions reported the BOD5/COD ratio is 0.03. The test substance is not readily biodegradable.
- Executive summary:
Method:
Internal method Nr. 16 and Nr.15
Results:
BOD5= 39 mg O2/g
COD= 1180 mg O2/g
BOD5/COD= 0.03
Conclusion:
Not readily biodegradable.
- Endpoint:
- biodegradation in water: inherent biodegradability
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- From April 16 to May 14, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The test was conducted by means of a read-across approach. The reliability of the source study report is 1.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 302 B (Inherent biodegradability: Zahn-Wellens/EMPA Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge: the aeration stage of the Severn Trent PLC Sewage Treatment Plant at Belper, Derbyshire, treating predominantly domestic sewage.
- Pretreatment: the sample was maintained at 21°C with continuous aeration and washed by settlement and resuspension in test medium prior to use.
- Concentration of sludge: equivalent to 1.0 g dry weight/L. - Duration of test (contact time):
- ca. 28 d
- Initial conc.:
- ca. 100 mg/L
- Based on:
- act. ingr.
- Parameter followed for biodegradation estimation:
- DOC removal
- Details on study design:
- Temperature: 22°C ± 1°C
Lighting: the test was conducted in darkness
Evaporation: losses by evaporation were made good by the addition of deionised water immediately prior to sampling.
Sampling: Aeration of the test vessels was stopped and the contents of the vessels allowed to Bettle for 20 minutes. Samples (appoximately 20 ml) were withdrawn from the supernatent and centrifuged at 3900 rpm for 15 minutes to remove any further suspended solids. Samples were analysed immediately. Samples were taken at 0 and 3 hours and an Days 7, 14, 21, 27 and 28 for dissolved organic carbon and spectrophotometric analysis. - Reference substance:
- diethylene glycol
- Parameter:
- % degradation (DOC removal)
- Value:
- > 4 - < 6
- Sampling time:
- 28 d
- Results with reference substance:
- Digol attained 100 % degradation within 14 days.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- not inherently biodegradable
- Conclusions:
- The inherent biodegradability of the test substance was determined in a 28 days Zahn-Wellens test, according to the OECD TG 302B. Under the experimental conditions reported the bioelimination of the test substance measured as DOC removal after 28 days is between 4% and 16%.
- Executive summary:
Methods:
The inherent biodegradability of the test substance was determined in a 28 days Zahn-Wellens -test according to the OECD Guideline for Testing of Chemicals, No. 302B.
Results:
Bioelimination of test substance measured as DOC removal after 28 days is between 4% and 16%.
Referenceopen allclose all
pH values did not drop below 5.2 in any culture vessel during the course of the study and were readjusted to between pH 7 and 8 daily. Dissolved oxygen levels remained at approximately 7.4 mg O2/L or above in all culture vessels at all times.
Description of key information
The inherent biodegradability of the test substance was determined in a 28 days Zahn-Wellens test, according to the OECD TG 302B. Under the experimental conditions reported the bioelimination of the test substance measured as DOC removal after 28 days is between 4% and 16%.
The test substance was tested for the determination of the BOD5/COD ratio following the internal methods Nr. 16 and Nr. 15. Under the experimental conditions reported the BOD5/COD ratio is 0.03. The test substance is not readily biodegradable.
Based on a QSAR prediction, the substance resulted as not readily biodegradable.
The substance is not readily biodegradable based on an expert judgement.
Key value for chemical safety assessment
- Biodegradation in water:
- not biodegradable
Additional information
No experimental studies on the "Biodegradation in water" are available for the substance in itself.
Nevertheless, two studies were conducted on an analogue substance (Similar Substance 01). Further information are reported in the Read Across justification attached to section 13.
Inherent biodegradability
The inherent biodegradability was determined in a Zahn-Wellens, test according to the OECD Guideline for Testing of Chemicals, No. 302B. The test has been performed in compliance with the Procedures and Principles of Good Laboratory. The test substance and the reference substance Diethylenglycol, respectively, were tested in concentrations of 100 mg/L ai.
The biodegradation of the test substance after 28 days was between 4% and 16%. The biodegradation of the reference substance after 14 days was 100%.
BOD5/COD ratio
Biochemical Oxygen Demand (BOD5) and Chemical Oxygen Demand (COD) are the most commonly used parameters for the characterization of the biodegradability capacity.
COD results are typically higher than BOD5 values, and their ratio varie depending on the characteristics of the substrate. This ratio has been commonly used as an indicator for biodegradation capacity, the "Biodegradability index" (B.I.).
As indicated in ECHA Guidance requirement R.7B, the BOD5 test is a traditional biodegradation test that is now replaced by the ready biodegradability tests. Therefore, this test should not be performed today for assessment of the ready biodegradability of substances.
Older test data may, however, be used when no other degradability data are available.
Studies on BOD5 and COD are available for this substance, therefore they have been used together with the inherent biodegradability OECD 302.B., in the weight of evidence approach for this substance.
COD was measured according to Method A-16. Details of the method have been not reported. The COD measured was 1180 mg/g O2.
BOD5 was measured according to Method A-15. Details of the method have been not reported. The BOD5 measured was 39 mg/g O2.
The ratio BOD5/COD is 0.03.
Moreover based on a QSAR prediction, the target substance is not readily biodegradable.
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.