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Diss Factsheets
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EC number: - | CAS number: -
- 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
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Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 20, 2015 to February 22, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EN ISO 10634:1995 - Guidance for the preparation and treatment of poorly soluble organic compounds for the subsequent evaluation of their biodegradability in an aqueous medium
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for testing of chemicals, 2006
- Version / remarks:
- Section 3, part 1
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Quality Assurance statement is at page 4 of the report
- Specific details on test material used for the study:
- Batch no.: 145
Dry matter: 37.6% in water (water to 100%)
Purity: 90.4% on the dry matter
Solubility: soluble in water
Being the report done before ECHA Agreement on substance name, the name on the report is L-Glutamic acid, N-(1-oxooctyl)-,sodium salt (1:2) but the substance tested is the reference substance. All raw materials used and manufacturing process are the same - Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, predominantly domestic, non-adapted
- Remarks:
- If inoculum was adapted, this would be written on the report, what is not. Substance is not widely used, annual production is lower than 10 ton. It is not ubiquitous in consumer products.
- Details on inoculum:
- - A sample of aerobic sludge that has been selected by the mixed treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco - Monza (MI).
- The inoculum was prepared in order to have a concentration of suspended solid of about 4 mg/L.
- Bacterial density after 5 dilution was brought to 20 10e5
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): A sample of aerobic sludge that has been selected by the mixed treatment plant of urban, that means domestic (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco - Monza (MI). Inoculum was not preadapted. See attached report for more information. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 20.88 mg/L
- Based on:
- TOC
- Parameter followed for biodegradation estimation:
- other: Total Inorganic Carbon (TIC) measured with a TOC analyser
- Details on study design:
- Bottles preparation:
- Medium preparation.
- 20 bottles for the test substance, for the blank, and for the reference substance to which the inoculum of the muds has been added (in five replicate bottles).
(Everything was done using deionized water).
- Incubation at 25 +/- 2°C for 28 days (under stirring in darkness). - Reference substance:
- benzoic acid, sodium salt
- Remarks:
- Purity 99%, used with the nominal concentration of 20.21 mg/l of organic carbon (TOC)
- Key result
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 90
- Sampling time:
- 28 d
- Details on results:
- - Total biodegradation (Dt) has been calculated using the equation:
Dt = (TICt - TICb)/TOCi*100
(TOCi = concentration of organic carbon of the test substance, in mg, added at the beginning).
- A substance is considered biodegradable when its level of biodegradability is at least 60%, within a period of 28 days. - Results with reference substance:
- Percentage of biodegradation (benzoic acid, sodium salt)after 14 days: 100%
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the study conditions, the substance was considered to be readily biodegradable under aerobic conditions
- Executive summary:
A study was conducted to determine the biodegradation in water of the substance according to OECD Guideline 310 and EN ISO 10634:1995, in compliance with GLP. Aerobic sludge collected from a mixed treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage was exposed to the test substance (act. ingr. 37.6%) for 28 days at 25 +/- 2°C (under stirring in darkness). Total inorganic carbon (TIC) was measured using an automatic TOC analyser and total biodegradation (Dt) was then calculated (Dt = (TICt - TICb)/TOCi*100). The biodegradation of the test substance was 90% after 28 days. The percentage of biodegradation for the positive control substance, i.e. benzoic acid, sodium salt after 14 days was 100. The experiment was valid. Under the study conditions, the substance was considered to be readily biodegradable under aerobic conditions (Giarei, 2016).
Reference
Table 1. Results
Check point (days) | % of biodegradation; Reference substance | % of biodegradation; Test substance |
0 | 0 | 0 |
1 | 9 | 19 |
6 | 95 | 87 |
14 | 100 | 101 |
21 | 105 | 83 |
28 | 104 | 90 |
Description of key information
Test used was OECD 310-2006. Even if on the report the name L-Glutamic acid, N-(1-oxooctyl)-,sodium salt (1:2) appears, the substance used is the same as the reference substance. All raw materials used and manufatuing process are the same. Name was changed after ECHA agreement to improve identification.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
- Type of water:
- other: Demi water
Additional information
A study was conducted to determine the biodegradation in water of the substance according to OECD Guideline 310 and EN ISO 10634:1995, in compliance with GLP. Aerobic sludge collected from a mixed treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage was exposed to the test substance (act. ingr. 37.6%) for 28 days at 25 +/- 2°C (under stirring in darkness). Total inorganic carbon (TIC) was measured using an automatic TOC analyser and total biodegradation (Dt) was then calculated (Dt = (TICt - TICb)/TOCi*100). The biodegradation of the test substance was 90% after 28 days. The percentage of biodegradation for the positive control substance, i.e. benzoic acid, sodium salt after 14 days was 100. The experiment was valid. Under the study conditions, the substance was considered to be readily biodegradable under aerobic conditions (Giarei, 2016).
[Type of water: freshwater]
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.
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