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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Environmental fate & pathways

Biodegradation in water: screening tests

Administrative data

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-10-25 to 2013-03-05
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate is included in the report (date of inspection: 16 and 17 June 2011)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-hydroxypropyl)oleamide
EC Number:
203-828-2
EC Name:
N-(2-hydroxypropyl)oleamide
Cas Number:
111-05-7
Molecular formula:
C21H41NO2
IUPAC Name:
N-(2-hydroxypropyl)oleamide
Constituent 2
Reference substance name:
N-(2-Hydroxypropyl) Oleamide
IUPAC Name:
N-(2-Hydroxypropyl) Oleamide
Test material form:
other: White waxy solid (at temperature ambiant)
Details on test material:
- Name of test material: N-(2-hydroxypropyl) oleamide
- Molecular formula : C21H41NO2
- Molecular weight : 339.56 g/mol
- Solubility in water: poorly
- Dry matter: 100%
- Lot/batch No.: T22221 without solvent
- pH: Not applicable
- Melting point: data not available
- Relative density: data not available
- Vapour pressure at 25°C: data not available
- Stability under test conditions: stable at room temperature
- Expiration date of the lot/batch: May 29th, 2014
- Storage condition of test material: room temperature

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
The inoculum was prepared from activated sludge sampled in the aeration tank treatment plant receiving predominantly domestic sewage (Montataire - (60) France). After settling, the supernatant of this activated sludge was used as inoculum with a microorganisms concentration of approximately 10.E7 active cells/L.
30 mL of inoculum were added per test flask when appropriate.

- inoculum collected on: 7 November 2012
- dry matter of activated sludge: 3.1 g/L
- Concentration of inoculum: - dry matter: 0.9 g/L
- approximately 10.E7 cells/L
- organic carbon content: 86.6 mg/L
- turbidity: 101 NTU

Duration of test (contact time):
0 - 28 d
Initial test substance concentration
Initial conc.:
13.46 - 26.92 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
TEST CONDITIONS

- Composition of medium: OECD 301 mineral medium
- Test temperature: between 21 and 24°C
- pH: initial pH of the mineral medium: 7.44
- pH adjusted: no
- Aeration of dilution water: No
- Suspended solids concentration: 10 mL/L of supernatant of activated sludge
- Continuous darkness: yes
- An appropriate amount of test item (40.4 mg for FE 1 and 80.8 mg for FE 2) was placed on microscope cover glass and directly introduced into the corresponding test flask with 3000 mL of test medium (as indicated in the standard NF EN ISO 10634: “Water quality: Guidance for the preparation and treatment of poorly water-soluble organic compounds for the subsequent evaluation of their biodegradability in an aqueous medium”).

TEST SYSTEM

- Number of culture flasks/concentration: one flask FE 1: 10 mg C/L and one flask FE 2: 20 mgC/L
- Method used to create aerobic conditions: aeration by the passage of carbon dioxide-free and water-free air
- Measuring equipment: titration material
- Test performed in open system: No
- Details of trap for CO2 and volatile organics if used: Ba(OH)2 trap (3 flasks of 100 mL)
- Other: Carbon analyzer SHIMADZU VSCN

SAMPLING

- Sampling frequency: every two days on average
- Sampling method: titration of one Ba(OH)2 flask
- Sample storage before analysis: No

CONTROL AND BLANK SYSTEM

- Inoculum control: yes (Aniline: FC: 20 mg C/L)
- Inoculum blank: yes
- Abiotic sterile control: yes (FA 20 mg C/L)
- Toxicity control: yes (F Inh. 20 + 20 mg C/L)
- Other: abiotic blank control
Reference substance
Reference substance:
aniline
Remarks:
Aniline, P.A. ACROS batch number: A0296028

Results and discussion

Preliminary study:
No preliminary study
% Degradation
Parameter:
% degradation (CO2 evolution)
Value:
86
Sampling time:
28 d
Remarks on result:
other: average value
Details on results:
At 13.46 mg /L (10 mg C/L): 65.4% after 7 d
89.5% after 28 d (90.8% after 29 d and acidification)
At 26.92 mg /L (20 mg C/L): 60.1% after 7 d
82.4% after 28 d (83.2% after 29 d and acidification)

BOD5 / COD results

Results with reference substance:
% biodegradation: 13 d (ThCO2): 81.1% (65.4% after 7 d)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
% biodeg. FC: 65.4% after 7d and toxicity control 68.6% after 13d; difference between extrem degradation values < 20%; CO2 evolution in controls <40 mg/L (the test item is poorly soluble in water, the inorganic carbon content has not been determined)
Interpretation of results:
readily biodegradable
Conclusions:
The pass level for ready biodegradability, 60% of ThCO2 has been reached in a 10-d window within the 28-d period of test and criteria for good evidence of “ready biodegradability” were reached in test conditions.
So, the test item N-(2-hydroxypropyl) Oleamide can be considered as readily biodegradable according to the OECD Guideline 301 for the testing of chemicals.
Executive summary:

TEST PURPOSE

Measurement, in defined conditions, of the biodegradability of an organic substance introduced in a liquid mineral medium inoculated with microbial flora from activated sludge.

TEST METHOD

OECD Guideline for the testing of chemicals 301 B: CO2Evolution Test (17 July 1992)

TEST ITEM

N-(2-hydroxypropyl) Oleamide

TEST CONCENTRATIONS

10 and 20 mg/L as organic carbon (O.C.) (nominal, initial concentrations)

REFERENCE ITEM

Aniline, 20 mg/L (O.C.)

INOCULUM

Prepared from activated sludge from a treatment plant receiving predominantly domestic sewage.

DURATION

28 days of incubation

RESULTS

 

          - % biodegradation (%ThCO2) after 28 days of incubation:

 

N-(2-hydroxypropyl) Oleamide

ANILINE

10 mg C/L

20 mg C/L

20 mg C/L

89.5%

82.4%

88.0%

Mean : 86.0%

/

 

CONCLUSION

The pass level for ready biodegradability, 60% of ThCO2has been reached in a 10-d window within the 28-d period of test andcriteria for good evidence of “ready biodegradability” were reached in test conditions.

So, the test itemN-(2-hydroxypropyl) Oleamidecan be considered as readily biodegradable according to the OECD Guideline 301 for the testing ofchemicals.