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Diss Factsheets
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EC number: 905-983-8 | 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
Toxicity to soil microorganisms
Administrative data
- Endpoint:
- toxicity to soil microorganisms
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON TERRESTRIAL MICROORGANISMS, OECD 216
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: ‘Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate’ (EC No. 905-983-8)
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: For ‘Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate’ (EC No. 905-983-8) no studies assessing the toxicity on terrestrial microorganisms are available yet.
- Available non-GLP studies: No further studies on terrestrial toxicity on microorganisms are available for ‘Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate’ (EC No. 905-983-8)
- (Q)SAR: There are no QSAR models available for this higher tier ecotoxicological endpoint that are sufficiently validated and acceptable (according to OECD Q/SAR validation criteria).
- Weight of evidence & Grouping and read-across: ‘Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate’ (EC No. 905-983-8) is not part of a category and no data on terrestrial toxicity on microorganisms for ‘Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate’ (EC No. 905-983-8) or related substances is available. There is thus no data supporting a weight of evidence or read-across approach and further testing is deemed necessary.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Recent experimental results from a chronic daphnia study (2021, according to OECD Guideline for the Testing of Chemicals, No. 211, "Daphnia magna, Reproduction Test) indicate chronic toxicity of ‘Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate’ (EC No. 905-983-8) towards aquatic invertebrates. Based on the determined NOEC (4.34 µg/L), the T criterion is fulfilled (NOEC ≤ 0.01 mg/L for marine/freshwater organisms) and there is indication that the registered substance is very toxic to aquatic organisms. In addition, the calculated range of the partition coefficient (logKOW between 4.80 and 8.12, individually calculated for the components) and the range of the adsorption coefficient (logKOC between 3.45 and 5.29, individually calculated for the components) are both indicative for a high adsorptive potential. Thus, based on the indications to be very toxic to aquatic organism and to be highly adsorptive, the registered substance is assigned to soil hazard category 4 as described in REACH Guidance document R7.c, Version 3.0 (June 2017). According to Table R.7.11-2 the screening assessment based on EPM is not recommended for substances assigned to hazard category 4. In order to derive the PNECsoil, and to assess the toxicity towards the terrestrial compartment, experimental studies are required.
The registrant has carefully considered the available adaptation possibilities applicable for the discussed endpoint. Based on the lack of studies conducted according to GLP (or with acceptable restrictions) on toxicity testing on soil microorganisms for the substance, it is deemed necessary to further investigate the toxicity potential of the substance according to Annex IX 9.4.2 REACh regulation.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The registrant intends to perform the toxicity on soil microorganisms according to OECD guideline 216, Soil Microorganisms: Nitrogen Transformation Test. According to the guideline, the study design of this study will fit to the physico-chemical properties of the test substance, as this study can deal with substances with low water solubility.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzyl 2-ethylhexyl adipate
- EC Number:
- 261-234-9
- EC Name:
- Benzyl 2-ethylhexyl adipate
- Cas Number:
- 58394-64-2
- Molecular formula:
- C21H32O4
- IUPAC Name:
- benzyl 2-ethylhexyl adipate
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Reference substance name:
- Dibenzyl adipate
- EC Number:
- 219-516-4
- EC Name:
- Dibenzyl adipate
- Cas Number:
- 2451-84-5
- Molecular formula:
- C20H22O4
- IUPAC Name:
- dibenzyl adipate
Constituent 1
Constituent 2
Constituent 3
Results and discussion
Applicant's summary and conclusion
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.