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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
30 OCT 2020 to 27 NOV 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Version / remarks:
July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MEP, P.R. China, the Guideline for the Testing of Chemicals, Degradation and Accumulation No. 301F “Manometric Respirometry Test”.
Version / remarks:
Second Edition (2013.9)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-Bromo-2-fluoro-N-methylbenzamide
EC Number:
808-257-8
Cas Number:
749927-69-3
Molecular formula:
C8H7BrFNO
IUPAC Name:
4-Bromo-2-fluoro-N-methylbenzamide
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch number of test material: FFP-106-200011
- Expiry date: 17 March 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 99.0%
- Purity test date: 21 MAR 2020
- Purity correction factor: no
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under storage conditions: no data
- Stability under test conditions: no data
- Solubility and stability of the test item in the solvent/vehicle: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: not applicable

Study design

Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
- Source of inoculum/activated sludge: domestic wastewater treatment plant, Shenyang North, P.R. China
- Storage conditions: aerobic conditions at 22.2 - 22.8°C
- Storage length: the inoculum was collected 2 days before the test exposure was started
- Preparation of inoculum for exposure: coarse particles were removed by filtration trough a fine sieve and the sample was allowed to settle; after the supernatant was discarded, the sludge was washed twice with mineral medium followed by resuspension in mineral medium;
- Concentration of sludge: 9.69 g/L as suspended solids (SS)

Duration of test (contact time):
28 d
Initial test substance concentration
Initial conc.:
85.6 mg/L
Based on:
ThOD
Parameter followed for biodegradation estimation
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST CONDITIONS
- Composition of medium: test water prepared according to test guidelines.
Mineral stock solution A
- KH2PO4, 4.2502 g
- K2HPO4, 10.8753 g
- Na2HPO4.2H2O 16.7001 g
- NH4Cl: 0.2500 g
Dissolved in Milli-Q water and made to 500 mL. The pH of the solution was 7.72, adjusted to 7.52 with HCl

Mineral stock solution B: 3.6403 g CaCl2.2H2O dissolved in 100 mL Milli-Q water
Mineral stock solution C: 2.2500 g MgSO4.7H2O dissolved in 100 mL Milli-Q water
Mineral stock solution E: 0.0251 g FeCl3.6H2O, 0.56 K2-EDTA dissolved in 100 mL Milli-Q water

For 1 liter of mineral medium, 10 mL stock solution A was added to approximately 800 mL distilled water and the mixture stirred before adding, sequentially, 1 mL each of stock solutions B, C and D. After mixing, the mixture was made up to 1 liter with distilled water. In total 5 L mineral medium was prepared. The pH of the mineral medium was 7.57.

- Suspended solids concentration: initially 30 mg dw/L
- Continuous darkness: yes
SAMPLING
- Sampling frequency: every day during 28 days
CONTROL AND BLANK SYSTEM
- Biotic control: yes, two replicates with inoculum
- Toxicity control: yes
- Procedure control: yes, 1 replicate with reference substance and inoculum
Reference substance
Reference substance:
benzoic acid, sodium salt
Remarks:
sodium benzoate

Results and discussion

% Degradation
Key result
Parameter:
% degradation (O2 consumption)
Value:
1.5
Sampling time:
28 d
Remarks on result:
other: average of two replicates

BOD5 / COD results

Results with reference substance:
The biodegradation of the reference substance (Sodium benzoate) attained 60.4% after 1 day and 20
hours, 81.5% after 14 days and 91.1% after day 28.

Any other information on results incl. tables

In the Toxicity Control (TC) test mixture, more than 25% biodegradation occurred within 14 days (40.3%, based on ThOD). Therefore, the test item was considered not to inhibit microbial activity under test conditions.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on the results, the percentage biodegradation of T003669 within 28 days did not exceed the pass level of 60% biodegradation based on ThOD. The test item did not meet the criteria for “ready biodegradability” under the described test conditions.