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Diss Factsheets

Administrative data

Endpoint:
biodegradation in soil: simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The results of a biodegradation test, performed according to OECD 301C, showed 1% biodegradation based on BOD and 2% biodegradation based on test material analysis at 28 days. No peak was observed in the HPLC chromatograms from a degradation product.
From the results of the ready biodegradation test, it is observed that no degradation products are formed in 28 days. If this is observed in a study with sludge, certainly no degradation products are anticipated in soil.
As the substance is not classified, no exposure and risk assessments are needed and thus no further degradation testing is proposed. Furthermore, as the substance itself is experimentally determined not to bioaccumulate (BCF < 61 L/kg) and thus not B/vB, no further information is needed on the Persistency (in accordance with the PBT Guidance Figure 11.3, step 4 (further information needed if substance also potentially B)).
Cross-reference
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03-Sep-2020 - 06-Oct-2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Method for Testing the Biodegradability of Chemical Substances by Microorganisms (301C)" stipulated in the "Testing Methods for New Chemical Substances" of Japanese Substances Control Law (March 31, 2011, Yakushokuhatsu 0331 No. 7; Heisei 23.03.29 Seikyo
Deviations:
no
GLP compliance:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Details on inoculum:
- Source of inoculum: On-site sludge sampling was carried out at 10 locations in Japan (samples were from surface water and surface soil of rivers, lake, and inland sea, and return sludge from sewage plants). (sampling period: July, 2020, initiation date of use: August 20, 2020).
- Preparation of inoculum: The activated sludge, which was cultivated for 19 hours after feeding with the synthetic sewage, was used. The synthetic sewage was prepared according to the following method: glucose, peptone, and potassium dihydrogenphosphate were dissolved in purified water, and the pH of the solution was adjusted to 7.0±1.0.
- Concentration of sludge: 3240 mg suspended solids/L.
- Concentration suspended solids in test concentration: Additive amount of the activated sludge into the test vessel was 2.78 mL (30 mg suspended solids/L).
Duration of test (contact time):
28 d
Initial conc.:
100 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Parameter followed for biodegradation estimation:
test mat. analysis
Details on study design:
TEST CONDITIONS
- Composition of medium: The basal culture medium (4 L) was prepared at the same proportion as the following method: each 3 mL aliquot of solutions A, B, C, and D, which are described in JIS K 0102:2019 Section 21 , was added to purified water (The Japanese Pharmacopoeia, Takasugi Pharmaceutical) and mixed solution was made up to 1 L. The pH of this solution was adjusted to 7.0.
- Test temperature: 25±1 °C, measured value 25.0°C
- Suspended solids concentration: 30 mg/L
- Continuous darkness: yes
- Test duration: 28 days
- Stirring: Each test solution was stirred with a stirrer.

TEST SYSTEM
- Culturing apparatus: Temperature controlled bath with measuring unit OM7000A (Ohkura Electric) and a data sampler OM7000A (Ohkura Electric)
- Vessel : All glass
- Absorbent for carbon dioxide: Soda lime
- Number of vessels: Test item vessel: 3 replicates containing 30 mg test item and sludge, Procedure control: 1 replicate containing 29.5 µL (30 mg)of Aniline and sludge, Abiotic control: 1 replicate containing 30 mg test item and water, Blank Control: 1 replicates containing basal medium and sludge.
- Volume of the test solution: total of 300 mL (including the 2.78 ml of activated sludge)
- Measurement of BOD: During the incubation period, BOD of the test solutions was measured continuously with a closed system oxygen consumption measuring apparatus. Measurements were performed on day 7, 14, 21 and 28.
- temperature measurement: The incubation temperature was measured and recorded once a day.
- pH measurement: At the end of the incubation period of the blank control and the test solution.
- Test performed in closed vessels: yes

SAMPLING
- Sampling frequency: At the end of the incubation period.
- Other: Determination of dissolved organic carbon (DOC) was not conducted because water solubility of the test item was less than 100 mg/L.

Reference substance:
aniline
Key result
Parameter:
% degradation (test mat. analysis)
Value:
2
Sampling time:
28 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
1
Sampling time:
28 d
Details on results:
The average percentage (bio)degradation was 1% by BOD and 2% by HPLC. Moreover, no peak corresponding to a degradation product was detected on the HPLC chromatograms
Results with reference substance:
90% biodegradation was observed in the reference item (BOD measurement)

Analytical results of the test solutions on Day 28 were as follows.










































 Water + test itemSludge + test itemtheoretical amount
vessel no. 2 vessel no. 3vessel no. 4
BOD*2mg    70.5
Residual amount and percentage of test item (by HPLC)mg29.929.229.229.230.0
 100979797 

*2 The value of the test solution (control blank) was subtracted from the values of the test solutions (sludge + test item).


 

Validity criteria fulfilled:
yes
Remarks:
"See overall remarks"
Interpretation of results:
not readily biodegradable
Conclusions:
The test item was not biodegraded under the test conditions of this study.
Executive summary:

A biodegradtion test was performed according to OECD 301C with Pegafast 425. The test item was tested in triplicate at a concentration of 100 mg/L. The incubation period ws 28 days. During the incubation period the BOD was measured on day 7, 14,21 and 28. At the end of the test period the concentration of the remaining test item was measured with HPLC. The test revealed a percentage biodegradtion by BOD of 1% at 28 days. At the end of the study the amount of test item remaining was 98% of initial.


In conclusion, pergafast 425 is not readily biodegradable. 

Data source

Materials and methods

Results and discussion

Transformation products:
no
Remarks:
The results of a biodegradation test, performed according to OECD 301C, showed 1% biodegradation based on BOD and 2% biodegradation based on test material analysis at 28 days. No peak was observed in the HPLC chromatograms from a degradation product.

Applicant's summary and conclusion