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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
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 March 22, 2022 to April 20, 2022
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- For the preparation of the inoculum a sample of aerobic sludge has been selected by the mixed
treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco
Monza (MB), Italia. The plant of treatment is managed by “BRIANZACQUE SRL (Monza)”. - Initial conc.:
- 32.13 mg/L
- Based on:
- TOC
- Parameter followed for biodegradation estimation:
- inorg. C analysis
- Details on study design:
- ASSAY EXECUTION
For assay execution the following preparations have been done using deionized water,
Boitles not used have been eliminated at the end of the test.
Test sample
The elemental analysis of the test item has been determined by REDOX Srl (see results in attachment
N. 3).
Because of the slight solubility of the test item in water, the sample was prepared by ultrasonic
dispersion according to UNI EN ISO 10634. About 20 g of the test sample was added to 800 mL of
medium. Then the sample was sonicated for 40 minutes at 40°C. Finally, the sample was let settle (1
nour) and the surplus was removed. The sample was analyzed at TOC analyzer and the value
obtained was considered as the initial measured concentration.
The sample has been used with the measured initial concentration of 32.13 mg/L of organic carbon
(TOC).
Reference substance
Considering 1-Octanol as reference substance using its molecular formula, a starting measured
concentration of 20.49 mg/L of organic carbon (TOC) has been used.
Blank
As blank has been used water containing culture Medium added with the inoculum of the muds.
Test sample + Reference substance
Test sample and reference substance have been put together in order to have a final concentration
given by the sum of organic carbon (TOC) of the 2 substances (see attachment N. 2 for results).
Abiotic check
Test item has been put together with 50 mg/L HgCle in order to check a possible abiotic degradation.
Conditions of assay
The inoculum has been added in all botiles (see bottle preparation), closed and incubation continued
under stirring in darkness at 20 + 1 °C for 28 days. Data recording is performed continuously by a
validated informatic monitoring system (Labgquard Evisense).
At least 1 hour before every determination of inorganic carbon (TIC) the reaction in one bottle of blank,
one of reference substance and one of the test item has been stopped with the addition of 6 mL of sodium hydroxide (1 M).
Triplicate bottles have been analyzed to detect inorganic carbon (IC) at each check point, except at the end of the test where five bottles have been analyzed. - Reference substance:
- other: 1-Octanol
- Key result
- Parameter:
- % degradation (inorg. C analysis)
- Value:
- 84
- Sampling time:
- 28 d
- Interpretation of results:
- readily biodegradable
- Conclusions:
- On the base of results obtained, interpreted in accordance to OECD 310:2014 and to Annex | to the OECD Guideline for Testing of Chemicals “Revised introduction to the OECD guidelines for testing of chemicals, section 3" (OECD, March 2006). the test item “L-LEUCINE, REACTION PRODUCTS WITH 1,4:3,6-DIANHYDRO-D-GLUCITOL, ISO-PR ALC. AND OCTANOYL CHLORIDE” (UVCB substance) should be considered readily biodegradable in aerobic conditions.
Reference
Check point (days) | % of biodegradation reference substance | % of biodegradation Test item | % of biodegradation reference substance + Test item |
0 | 0 | 0 | 0 |
1 | 44 | 3 | 17 |
3 | 73 | 21 | - |
13 | 94 | 59 | - |
21 | 105 | 85 | - |
28 | 90 | 84 | 92 |
Description of key information
On the base of results obtained, interpreted in accordance to OECD 310:2014 and to Annex | to the OECD Guideline for Testing of Chemicals “Revised introduction to the OECD guidelines for testing of chemicals, section 3" (OECD, March 2006). the test item “L-LEUCINE, REACTION PRODUCTS WITH 1,4:3,6-DIANHYDRO-D-GLUCITOL, ISO-PR ALC. AND OCTANOYL CHLORIDE” (UVCB substance) should be considered readily biodegradable in aerobic conditions.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
- Type of water:
- freshwater
Additional information
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.