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LEGAL NOTICE

 

The European Chemicals Agency (hereinafter “ECHA”) maintains this website
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NAVIGATION

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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Please be aware that this old REACH registration data factsheet is no longer
maintained; it remains frozen as of 19th May 2023.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.

Access ECHA CHEM


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.

REACH


AMIDES, C8-18 (EVEN NUMBERED) AND C18-UNSATD., N-(HYDROXYETHYL)

 * 
 * 

EC number: 931-330-1 | CAS number: 69227-24-3

 * General information
 * Classification & Labelling & PBT assessment
 * Manufacture, use & exposure
 * Physical & Chemical properties
 * Environmental fate & pathways
 * Ecotoxicological information
 * Toxicological information
 * Analytical methods
 * Guidance on safe use
 * Assessment reports
 * Reference substances
 * Categories

 * Substance Identity
 * Administrative Information

 * GHS
 * DSD - DPD
 * PBT assessment

 * Life Cycle description
   * No identified uses
   * Manufacture
   * Formulation
   * Uses at industrial sites
   * Uses by professional workers
   * Consumer Uses
   * Article service life
 * Uses advised against
   * Formulation
   * Uses at industrial sites
   * Uses by professional workers
   * Consumer Uses

 * 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
   * Endpoint summary
   * Phototransformation in air
   * Hydrolysis
   * Phototransformation in water
   * Phototransformation in soil
 * Biodegradation
   * Endpoint summary
   * Biodegradation in water: screening tests
   * Biodegradation in water and sediment: simulation tests
   * Biodegradation in soil
   * Mode of degradation in actual use
 * Bioaccumulation
   * Endpoint summary
   * Bioaccumulation: aquatic / sediment
   * Bioaccumulation: terrestrial
 * Transport and distribution
   * Endpoint summary
   * Adsorption / desorption
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   * Other distribution data
 * Environmental data
   * Endpoint summary
   * Monitoring data
   * Field studies
 * 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
   * Endpoint summary
   * Toxicity to soil macroorganisms except arthropods
   * Toxicity to terrestrial arthropods
   * Toxicity to terrestrial plants
   * Toxicity to soil microorganisms
   * Toxicity to birds
   * Toxicity to other above-ground organisms
 * Biological effects monitoring
 * Biotransformation and kinetics
 * Additional ecotoxological information

 * Toxicological Summary
 * Toxicokinetics, metabolism and distribution
   * Endpoint summary
   * Basic toxicokinetics
   * Dermal absorption
 * Acute Toxicity
   * Endpoint summary
   * Acute Toxicity: oral
   * Acute Toxicity: inhalation
   * Acute Toxicity: dermal
   * Acute Toxicity: other routes
 * Irritation / corrosion
   * Endpoint summary
   * Skin irritation / corrosion
   * Eye irritation
 * Sensitisation
   * Endpoint summary
   * Skin sensitisation
   * Respiratory sensitisation
 * Repeated dose toxicity
   * Endpoint summary
   * Repeated dose toxicity: oral
   * Repeated dose toxicity: inhalation
   * Repeated dose toxicity: dermal
   * Repeated dose toxicity: other routes
 * Genetic toxicity
   * Endpoint summary
   * Genetic toxicity: in vitro
   * Genetic toxicity: in vivo
 * Carcinogenicity
 * Toxicity to reproduction
   * Endpoint summary
   * Toxicity to reproduction
   * Developmental toxicity / teratogenicity
   * Toxicity to reproduction: other studies
 * Specific investigations
   * Neurotoxicity
   * Immunotoxicity
   * Endocrine disrupter mammalian screening – in vivo (level 3)
   * Specific investigations: other studies
   * Phototoxicity in vitro
 * Exposure related observations in humans
   * Endpoint summary
   * Health surveillance data
   * Epidemiological data
   * Direct observations: clinical cases, poisoning incidents and other
   * Sensitisation data (human)
   * Exposure related observations in humans: other data
 * Toxic effects on livestock and pets
 * Additional toxicological data






Environmental fate & pathways


BIODEGRADATION IN WATER: SCREENING TESTS

Currently viewing: S-01 | SummaryS-02 | Summary (JS Member)001 Key |
Experimental result002 Key | Experimental result
 * Administrative data
 * Link to relevant study record(s)
 * Description of key information
 * Key value for chemical safety assessment
 * Additional information


ADMINISTRATIVE DATA


LINK TO RELEVANT STUDY RECORD(S)

REFERENCEOPEN ALLCLOSE ALL

REFERENCE 1

Endpoint:biodegradation in water: ready biodegradabilityType of
information:experimental studyAdequacy of study:key studyStudy period:From March
10, 1997 to April 09, 1997Reliability:1 (reliable without restriction)Rationale
for reliability incl. deficiencies:guideline studyQualifier:according to
guidelineGuideline:OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution
Test)Deviations:noQualifier:according to guidelineGuideline:EU Method C.4-C
(Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution
Test)Deviations:noGLP compliance:not specifiedOxygen conditions:aerobicInoculum
or test system:activated sludge, domestic, non-adaptedDetails on inoculum:-
Source of inoculum/activated sludge: Activated sludge micro-organisms were
obtained on March 10, 1997, from the aeration stage of the Severn Trent Water
plc sewage treatment plant at Belper, Derbyshire, treating predominantly
domestic sewage.
- Preparation of inoculum for exposure: 100 mL samples were filtered through
Whatman GF/A paper and dried at 105 °C.
- Pretreatment: Sample washed 3 times by settlement and resuspension in culture
medium prior to suspended solids determination. Samples were maintained on
aeration at 21°C prior to use.
- Concentration of sludge: 30 mg TSS/L
- Initial cell/biomass concentration:
- Water filtered: Yes
- Type and size of filter used, if any: Whatman GF/A paper Duration of test
(contact time):ca. 28 dInitial conc.:20 mg/LBased on:DOCParameter followed for
biodegradation estimation:CO2 evolutionDetails on study design:TEST CONDITIONS
- Composition of medium: Standard culture medium according to OECD 301B.
- Test temperature: 22±2°C
- pH: 7.4
- Aeration of dilution water: Yes, see below
- Suspended solids concentration: 30 mg TSS/L
- Continuous darkness: Yes, in darkness sheilded from laboratory lighting


TEST SYSTEM
- Culturing apparatus: 5 L glass culture vessels
- Number of culture flasks/concentration: Two for every conc.
- Method used to create aerobic conditions: Using CO2 free air at 30-100 mL/min
- Method used to create anaerobic conditions: Not applicable
- Other:
- Method of preparation of test solution: Direct dispersion in culture medium.
-Agitation: Yes, using magnetic stirrer


SAMPLING
- Sampling frequency: On Day 0, 1, 2, 3, 6, 8, 10, 14, 16, 20, 22, 24, 27, 28
and 29.
- Sampling method: 2 mL of samples were taken on the days specified above for IC
analysis.
- Sample storage before analysis: Samples taken on Days 12 & 18 were stored at
-20°C


CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes
- Abiotic sterile control: No
- Toxicity control: No, since a preliminary study performed on Empilan CME
indicated that, the test material is non-toxic and does not inhibit the
respiration of sewage sludge micro-organisms at the concentration employed in
the test.
- Reference control: Yes


Reference substance:benzoic acid, sodium saltRemarks:10 mg C/L (ThCO2 =58.34%;
TOC = 30 mg C; total carbon = 51.4 mg)Preliminary study:The oxygen consumption
rates (mg O2/L) for the inoculum blank was 0.43 for both replicates; for the
test material it was 0.46 and 0.42 at 10 and 20 mg C/L respectively and for
reference material it was 0.38 and 0.11 at 3.2 and 32 mg/L respectively. Hence,
toxicity control was omitted from the study.Test performance:- The decrease of
percentage degradation value for the test material from 99% on Day 28 to 98% on
Day 29 due to the increase in inorganic carbon (caused by addition of HCl) in
the control absorber vessels was greater than that in the standard material
absorber vessels and this decrease is considered to be due to biological
variation between the activated sewage sludge in the control and standard
material vessels.
- Inorganic carbon analysis of samples from the second absorber vessels on Day
29 confirmed that no significant carry-over of CO2 into the second absorber
vessels occurred.
- Sodium benzoate attained 97% degradation after 28 d thereby confirming the
suitability of the inoculum and test conditions.
- Toxicity control was omitted from the study, in light of results of a
preliminary investigation of the test material. These results carried out using
Activated Sludge Respiration Inhibition test method (OECD Guideline No 209),
indicated that Empilan CME did not inhibit the respiration of sewage sludge
micro-organisms at the concentration employed in the test.
- Low DOC values obtained for the samples taken from the test material culture
vessels on day 0 are due to physical removal of the test material by the
suspended solids during centrifugation. This effect is considered to be due to
the test material being a fine homogenous and not a true solution at the
concentrations employed in the study.Key resultParameter:% degradation (CO2
evolution)Value:ca. 24 Sampling time:3 dKey resultParameter:% degradation (CO2
evolution)Value:ca. 62 Sampling time:8 dKey resultParameter:% degradation (CO2
evolution)Value:ca. 99 Sampling time:28 dDetails on results:- Percent
degradation values: 0, 3, 9, 24, 54, 62, 69, 72, 92, 97, 98, 96, 99, 99 and 98
after 0, 1, 2, 3, 6, 8, 10, 14, 16, 20, 22, 24, 27, 28 and 29 d.
- The measured concentrations of DOC was found to be 56% of nominal on Day 0 and
17 to 26% of nominal on Day 28.
Results with reference substance:The reference material met the validity
criteria for the test, greater than 60% biodegradation within 14 d, and within
the 10 d window (Day 2 = 22%, Day 10 = 64%, Day 28 = 97% ThCO2).
- The increase in inorganic carbon in the first absorber vessels on Day 29
resulted in an increase in the percentage degradation value for the standard
material from 97% on Day 28 to 98% on Day 29.

None.

Validity criteria fulfilled:yesRemarks:However, the data on replicate difference
and the biodegradation data for control were not documented.Interpretation of
results:readily biodegradableConclusions:Under the study conditions, the test
substance was considered to be readily biodegradable.Executive summary:

A study was conducted to determine the ready biodegradability of the test
substance, C8-18 and C18-unsatd. MEA, according to OECD Guideline 301B (CO2
evolution test). The test (20 mg C/L) and reference (sodium benzoate) substances
were incubated with activated sludge and observed for degradation by measurement
of the theoretical amount of carbon dioxide (ThCO2) over a 28 d period. The
reference substance, sodium benzoate reached 10% biodegradation after Day 2 and
> 60% after Day 10. It met the validity criteria established in the guideline
for a reference substance. Biodegradation of the test substance on Day 28
equalled 99%. Under the study conditions, the test substance was considered to
be readily biodegradable (Mead, 1997).

REFERENCE 2

Endpoint:biodegradation in water: ready biodegradabilityType of
information:experimental studyAdequacy of study:key studyStudy period:From April
29, 2008 to June 06, 2008Reliability:1 (reliable without restriction)Rationale
for reliability incl. deficiencies:guideline studyQualifier:according to
guidelineGuideline:OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution
Test)Deviations:noGLP compliance:yes (incl. QA statement)Oxygen
conditions:aerobicInoculum or test system:activated sludge (adaptation not
specified)Details on inoculum:- Source of inoculum/activated sludge: Municipal
wastewater treatment plant Breisgauer Bucht, sampling date of activated sludge
was Aug. 4, 2008. Dry solid of the activated sludge was determined as 5.9 g/L by
weight measurements after 3.5 h drying at 105°C (mean of triplicate
measurements).
- Preparation of inoculum for exposure: The activated sludge was washed twice by
settling the sludge, decanting the supernatant and resuspending the sludge in
aerated tap water.
- Concentration of sludge: 30 mg dry solids per litreDuration of test (contact
time):ca. 28 dInitial conc.:ca. 20 mg/LBased on:DOCParameter followed for
biodegradation estimation:inorg. C analysisDetails on study design:TEST
CONDITIONS
- Composition of medium:
Mineral medium:
A. KH2PO4 8.50 g
K2HPO4 21.75 g
Na2HPO4*2H2O 33.40 g
NH4Cl 0.50 g
Demineralised water q.s. 1 litre
B. CaCl2*2H2O 36.4 g
Demineralised water q.s. 1 litre
C. MgSO4*7H2O 22.5 g
Demineralised water q.s. 1 litre
D. FeCl3*6H2O 0.25 g
Demineralised water q.s. 1 litre and stabilised with one drop of concentrated
HCl
For preparation of the mineral medium 10 mL of solution (A) was mixed with 800
mL demineralised water, 1 mL each of solutions (B), (C) and (D) were added and
the volume was made up to 1 litre.
- Test temperature: 20-22°C
- Aeration of dilution water: 50-100 mL/min (2.7 - 5.5 bubbles/second)
- Continuous darkness: No
- Other: The reactors were kept mixed with magnetic stirrers. The aeration rate
was determined visually daily on working days, the determination by counting the
gas bubbles over a defined period using a stop watch was made at day 6 and 28.
The CO2-free air production system, the air-tightness of the whole experimental
set-up, the aeration of the absorber flasks and the magnetic stirrers were
controlled daily on working days.


TEST SYSTEM
- Culturing apparatus: Gas wash bottles (2000 mL volume) with lateral connecting
pieces for butyl rubber septums were used as reactors.
- Number of culture flasks/concentration: Three reactors each for the test
material, inoculum (blank) reference substance
- Method used to create aerobic conditions: The CO2-free air was passed on to an
air distributor with two input and 22 output channels and through PE-tubes.
- Measuring equipment: IC measurement was performed with a total carbon analyser
(TOC-5000A Shimadzu with an autosampler ASI-5000A) by purging the inorganic
carbon with H3PO4 (25 %) using a non dispersive infrared (NDIR) detector.
- Test performed in closed vessels: Yes
- Details of trap for CO2: The vials were immediately closed with sealing film
in order to avoid CO2 uptake from the air.
- Other: 4.82 mL of the stock solution of the test material (10 g/L) was added
into the three test vessels, corresponding to a TOC concentration of 20 mg/L.
The reference compound (5.15 ml of a 10 g/l stock solution) was added to the
reference vessels.


SAMPLING
- Sampling frequency: At the beginning of the study, 3rd, 6th, 10th, 14th, 21st
and 28th day
- Sampling method: Sampling was performed through the lateral connecting pieces
through the butyl rubber septum using 5 mL PE syringes.
- Other: 4 mL NaOH from the first of two CO2-absorber flasks connected in line
was sampled and the IC's were determined. On the 28th day 1 mL concentrated
hydrochloric acid (HCl) was added into each reactor to release the CO2 dissolved
in water. On day 29 the IC was determined in both CO2-absorber flasks in line.


CONTROL AND BLANK SYSTEM
- Inoculum blank: YesReference substance:benzoic acid, sodium saltRemarks:Roth,
Lot 26461087, Molecular weight: 144.1 g/mol, Storage-conditions: Room
temperature, Durability: Nov. 3, 2009, Solubility in water: Soluble, C-content:
0.583 mg/mg (calculation by Hydrotox), ThCO2: 2.137 mg/mg (calculation by
Hydrotox)Key resultParameter:% degradation (inorg. C analysis)Value:ca. 88.3
Sampling time:28 dDetails on results:The mean degradation extent of the test
material was 88.3% within 28 d after acidification (mean value of three test
vessels). For finding the exact position of the 10 d window the degradation
extents of the days without measurement were calculated by interpolation. On Day
1 the calculated mean degradation extent of the test material was for the first
time higher than 10% (mean value: 11.7%). Thus the end of the 10 d window was on
Day 11. The calculated degradation extent on Day 11 was 85.5% (mean value).
Therefore the test material reached the pass level for ready biodegradability
(60% ThCO2 and 10 d window).Results with reference substance:The reference
substance reached the pass levels for ready biodegradability within 3 d.



Blank: The highest mean CO2-evolution of the blank flasks in both test series
was 34.6 mg/L within 28 d after acidification (see table 2 of the attached study
report). Before adding the test material, the IC in the reactor was determined,
but no IC was found. The IC concentration of the NaOH in the second CO2-absorber
flasks in line, used as protective flasks, was below 5 ppm and was not
considered in the data processing, because CO2 absorption from room air was its
source.


Criteria met for the validity of the study:


- The IC content in the test vessel was less than 5% of the TOC introduced with
the test material.


- The CO2 evolution in the inoculum blank at the end of the test was below 40
mg/L.


- The difference of extremes of replicate values at the end of the 10-d-window
and at the end of the test was less than 20 %.


- The biodegradation of the reference compound reached the pass level of 60 %
ThCO2 by day 14.


 


Table 1: Ultimate biodegradation after x days [% of ThCO2]




























































































Reactor 



Day 



0



3



6



10



14



21



28



28 (after acidification) 



16



Test flasks 



0



40,5



70,4



83,2



90,1



96,5



91,2



84,5



17



 



0



21,6



73,0



81,1



85,5



91,6



88,9



84,7



18



 



0



43,4



74,3



86,9



96,2



101,5



100,5



95,6



4



Reference flasks 



0



73,9



91,4



96,5



102,3



117,0



107,6



108,3



5



 



0



66,5



90,6



95,9



99,5



106,8



89,2



91,5



6



 



0



68,4



93,8



99,4



102,6



109,7



102,3



95,8



 

Validity criteria fulfilled:yesInterpretation of results:readily
biodegradableConclusions:Under the study conditions, the test substance was
considered readily biodegradable.Executive summary:

A study was conducted to determine the ready biodegradability of the test
substance, C8-18 and C18-unsatd. MEA, according to OECD Guideline 301B (CO2
evolution test), in compliance with GLP. A mineral medium, corresponding to
10-20 mg total organic carbon (TOC)/L, was inoculated with activated sludge (30
mg d.s./L). The test vessels were aerated by the passage of CO2-free air and
incubated under aerobic conditions for 28 d. Degradation was followed by
determining the CO2 produced and absorbed to sodium hydroxide via IC-measurement
on Days 3, 6, 10, 14, 21 and 28 of the study. The reference substance used was
sodium benzoate at a concentration of 20 mg/L organic carbon. The reference
substance reached the pass levels for ready biodegradability within 3 d. The
mean degradation extent of the test substance was 88.3% within 28 d after
acidification (mean value of three test vessels). Under the study conditions,
the test substance was considered readily biodegradable (Kronenberger-Schäfer,
2008).


DESCRIPTION OF KEY INFORMATION


KEY VALUE FOR CHEMICAL SAFETY ASSESSMENT

Biodegradation in water:readily biodegradableType of water:freshwater


ADDITIONAL INFORMATION

A study was conducted to determine the ready biodegradability of the test
substance, C8-18 and C18-unsatd. MEA, according to OECD Guideline 301B (CO2
evolution test), in compliance with GLP. A mineral medium, corresponding to
10-20 mg total organic carbon (TOC)/L, was inoculated with activated sludge (30
mg d.s./L). The test vessels were aerated by the passage of CO2-free air and
incubated under aerobic conditions for 28 d. Degradation was followed by
determining the CO2 produced and absorbed to sodium hydroxide via IC-measurement
on Days 3, 6, 10, 14, 21 and 28 of the study. The reference substance used was
sodium benzoate at a concentration of 20 mg/L organic carbon. The reference
substance reached the pass levels for ready biodegradability within 3 d. The
mean degradation extent of the test substance was 88.3% within 28 d after
acidification (mean value of three test vessels). Under the study conditions,
the test substance was considered readily biodegradable (Kronenberger-Schäfer,
2008).

A study was conducted to determine the ready biodegradability of the test
substance, C8-18 and C18-unsatd. MEA, according to OECD Guideline 301B (CO2
evolution test). The test (20 mg C/L) and reference (sodium benzoate) substances
were incubated with activated sludge and observed for degradation by measurement
of the theoretical amount of carbon dioxide (ThCO2) over a 28 d period. The
reference substance, sodium benzoate reached 10% biodegradation after Day 2 and
> 60% after Day 10. It met the validity criteria established in the guideline
for a reference substance. Biodegradation of the test substance on Day 28
equalled 99%. Under the study conditions, the test substance was considered to
be readily biodegradable (Mead, 1997).

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that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH
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