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Diss Factsheets
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EC number: 262-334-5 | CAS number: 60623-04-3
- 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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Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to microorganisms
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see chapter 13 read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 16 h
- Dose descriptor:
- other: EL10
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- other: EL50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Key result
- Duration:
- 16 h
- Dose descriptor:
- other: NOELR
- Effect conc.:
- >= 10 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- (WAF)
- Basis for effect:
- growth inhibition
- Reported statistics and error estimates:
- The percentage inhibitory effect on cell multiplication was calculated for each test material concentration using the equation stated in the ISO guideline. A Students t-test was carried out on the absorbance values after approx. 16 h exposure for the control and 10000 mg/L loading rate WAF test concentration.
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see chapter 13 read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Key result
- Duration:
- 3 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- inhibition of total respiration
- Remarks:
- respiration rate
- Details on results:
- The test substance showed no inhibitory effect on the respiration rate of activated sludge at any of the concentrations employed in the test. Respiration rates of mixtures containing the test substance showed an increase in respiration rate above that of the controls.
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: EC50 (3h) = 6.4 mg/L (4.1 - 9.6 mg/L)
Referenceopen allclose all
Table 1: Mean absorbance values from the definitive study (n.d. = not determined)
Nominal Loading Rate [mg/L] |
Absorbance Value |
|
0 h |
16 h |
|
Control |
0.011 |
1.247 |
10000 |
n.d. |
1.246 |
Table 1: Preparation of test solutions
Treatment |
Test substance [µL] or reference substance [mL] |
Synthetic sewage [mL] |
RO water [mL] |
Microbial Inoculum [mL] |
Control 1 |
0 |
16 |
284 |
200 |
Control 2 |
0 |
16 |
284 |
200 |
Test substance [mg/L] |
|
|
|
|
10 |
5.1 |
16 |
284 |
200 |
100 |
50 |
16 |
284 |
200 |
1000 |
505 |
16 |
284 |
200 |
Reference substance [mg/L] |
|
|
|
|
3 |
3 |
16 |
281 |
200 |
10 |
10 |
16 |
274 |
200 |
32 |
32 |
16 |
252 |
200 |
Table 2: Dissolved oxygen concentration and measurement times
Treatment |
Initial dissolved oxygen conc. in culture [mg O2/L] |
Initial measured dissolved oxygen conc. [mg O2/L] |
Final measured dissolved oxygen conc. [mg O2/L] |
Measurement time [min] |
Control 1 |
6.9 |
6.5 |
2.5 |
8.5 |
Control 2 |
6.9 |
6.5 |
2.5 |
9.0 |
Test substance [mg/L] |
|
|
|
|
10 |
4.5 |
4.2 |
1.5 |
5.3 |
100 |
5.0 |
4.8 |
1.5 |
6.3 |
1000 |
5.8 |
5.5 |
2.5 |
5.7 |
1000 |
4.9 |
4.6 |
1.5 |
5.8 |
1000 |
5.5 |
4.9 |
2.0 |
5.8 |
Reference substance [mg/L] |
|
|
|
|
3 |
7.0 |
6.5 |
3.2 |
9.5 |
10 |
8.0 |
7.8 |
5.8 |
9.9 |
32 |
7.4 |
8.1 |
7.7 |
8.1 |
Table 3: Measurement of respiration rate
Treatment |
Specific respiration rate [mg O2/g/h] |
% inhibition or stimulation () |
Control 1 |
17.6 |
- |
Control 2 |
16.7 |
- |
Test substance [mg/L] |
|
|
10 |
19.1 |
0 (11) |
100 |
19.6 |
0 (14) |
1000 |
19.7 |
0 (15) |
1000 |
20.0 |
0 (17) |
1000 |
18.8 |
0 (9) |
Reference substance [mg/L] |
|
|
3 |
13.0 |
24 |
10 |
7.6 |
56 |
32 |
1.9 |
89 |
Description of key information
EL50 (16 h) > 10000 mg/L (ISO 10712)
Key value for chemical safety assessment
Additional information
In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to two structurally related sub-category members pentaerytritol tetraoleate (CAS 19321-40-5)and decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) was conducted to fulfill the data requirements according to Annex IX forfatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) in regard to toxicity to microorganisms.This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment. The fatty acid chain length of C16 and C18 of the first read-across substances are identical to those of the target substance. The second read-across substance covers the other end of the sub-category with shorter fatty acid chain lengths (C5-10). All substances contain the same alcohol (pentaerythritol) and are tetra-esters. As it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.
The first study with the read-across substancepentaerytritol tetraoleate (CAS 19321-40-5)was conducted under static conditions according to ISO 10712 investigating aquatic microorganisms (Mead, 1997). In this GLP study an aqueous suspension of Pseudomonas putida was used as inoculum. A nominal test concentration of 10000 mg/L was used (prepared as WAF). The test substance did not inhibit the growth of Pseudomonas putida. Hence, the 16 h-EL50 was determined to be > 10000 mg/L based on the nominal test concentration.
The second study with the read-across substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) supports this result. It was conducted under static conditions according to OECD 209 investigating aquatic microorganisms (Dickinson, 2008). In this GLP studynon-adapted activated sludge obtained from a domestic sewage treatment plant was used as inoculum. Test concentrations of 10, 100 and 1000 mg/L were prepared. Test substance was added directly to the test vessels. The test substance did not inhibit the respiration rate of activated sludge microorganisms at any of the concentrations employed in the test. Hence, the 3 h-EC50 was determined to be > 1000 mg/L based on the nominal test concentration. Therefore it can be concluded that the test substance will not exhibit effects on the respiration rate of microorganisms.
Based on these results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) will not exhibit inhibitory effects to aquatic microorganism.
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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