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EC number: 807-422-1 | CAS number: 66918-01-2
- 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
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- Cas Number:
- 66918-01-2
- Molecular formula:
- C40H78O5
- IUPAC Name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- Details on test material:
- - Name of test material (as cited in study report): SALACOS 222
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 7-2-D
- Expiration date of the lot/batch: 04/10
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: room temperature (20 +/- 0.5 °C), light protected
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 7-2-D
- Expiration date of the lot/batch: April 2010
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, away from direct sunlight
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: assumed stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: assumed stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure):
- origin: wastewater treatment plant (ARA Ergholz II, Füllinsdorf; Switzerland)
- Preparation of inoculum for exposure: sludge was washed twice by centrifugation and the supernatant liquid phase was decanted
- Pretreatment: determination of ratio dry/wet weight; suspension in test water (conc. eq.: 4 g wet weight/L); holding for two days (aeration at room temp.); prior to use two-step dilution: 1 g wet weight/L, 30 mg wet weight/L
- Concentration of sludge: 30 mg dry weight/L - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: according to Guideline
- Additional substrate: none
- Solubilising agent (type and concentration if used):
- Test temperature: 22 °C
- pH: start: 7.5; end: 7.5-7.9
- pH adjusted: no
- CEC (meq/100 g):
- Aeration of dilution water:
- Suspended solids concentration:
- Continuous darkness: yes
- Other:
TEST SYSTEM
250 mL test solution per flask,
Due to the complex structure (composition) of the test item, its chemical oxygen demand (COD)
was determined according to theEU Commission Directive 92/69氾EC, C.6 following DIN
38414-S9.
The COD was detemined at BMG Engineering AG, Ifangstrasse 11, 8952 Schlieren I
Switzerland. The COD determination was not performed in compliance with the GLP regulations.
SAMPLING
- Sampling frequency: dayly
- Sampling method: cumulative oxygen consumption
- Sterility check if applicable: not stated
- Sample storage before analysis: not stated
- Other:
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: none
- Toxicity control:yes
- Other:
STATISTICAL METHODS: none applied
Reference substance
- Reference substance:
- benzoic acid, sodium salt
Results and discussion
% Degradation
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 0
- Sampling time:
- 28 d
- Details on results:
- The percent biodegradationof the test item was calculated based on the chemical oxygen
demand (COD) of 1.34 mg O2/mg test item.
The biochemical oxygen demand (BOD) of the test item in the test media was in
the normal range found for the inoculum controls throughout the study period of 28 days.
BOD5 / COD results
BOD5 / COD
- Key result
- Parameter:
- COD
- Value:
- 1.34 mg O2/g test mat.
- Results with reference substance:
- reference item was degraded by an average of 83% by Exposure Day 14. At the end of the test (day 28), the reference item was degraded by an average of 85%.
Any other information on results incl. tables
Validity of the test:
the substance was tested in duplicate and differences in values for the test item are negligable.
Toxicity control replicate showed no toxicity.
The cumulative oxygen consumption of the reference item was > 60 mg/L at the end of 28 days. However, as the test item was not biodegradable, this constraint is assesseed uncritical for the result of the study.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- under test conditions no biodegradation observed
- Conclusions:
- The biodegradation of the test item was determined in an manometric respiratory test according to the OECD testing guideline 301F. Although the suitability of the used test system was shown in the reference test, no biodegradation of the test item was observed during the test period. Thus, the test item is considered to be not readily biodegradable under the given test conditions. The presented data should be assumed to be relevant, reliable and adequate for the purpose of a REACH registration.
- Executive summary:
The test item was investigated for its ready biodegradability in a manometric
respirometry test over 28 days according to the EU Commission Directive 92/69 EEC, C.4 -D
(1992) and the OECD Guideline for Testing of Chemicals No. 301 F (1992).
The biochemical oxygen demand (BOD) of the test item in the test media was in
the normal range found for the inoculum controls.
Consequently, the test item was not biodegradable under the test conditions within 28 days.
In the toxicity control, containing both the test item and the reference item sodium benzoate,
the test item had no inhibitory effect on the activity of activated sludge microorganisms at the
tested concentration of 100 mg/L.
In the procedure controls, the reference item sodium benzoate was degraded by an average of
83% by Exposure Day 14, and reached an average biodegradation of 85% by the end of the test
(Day 28), thus confirming suitability of the activated sludge.
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