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Toxicity to microorganisms

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toxicity to microorganisms, other
Study was a toxicity control conducted as part of a CO2 evolution test in accordance with OECD Guideline 301B.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 January 2018 to 01 March 2018
1 (reliable without restriction)
Justification for type of information:
Reliable experimental study following OECD 301 guidelines (1992) and EC No. 440/2008 Method C.4-C adopted 2008 and GLP standards.

according to guideline
other: OECD 301B
Version / remarks:
OECD 301 guidelines (1992)
according to guideline
other: EC No. 440/2008
Version / remarks:
Method C.4-C adopted 2008
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
The test substance is listed as Pentamid™ KH (Methyl N-octadecylterephthalamate). The test substance consists of a solid (100% purity) and was obtained from the Sponsor, Vertellus Holdings LLC and stored at ambient conditions.
Analytical monitoring:
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
Activated sludge was collected from the Easton Wastewater Treatment Facility, Easton, Maryland on January 08, 2018. The Easton facility treats predominantly residential wastes. The sludge was sieved using a 2-mm screen, adjusted to approximately 1,000 mg total suspended solids/L with mineral media and then aerated at 20 ± 3˚C for approximately 48 hours.
Test type:
Water media type:
Limit test:
Total exposure duration:
46 d
Test temperature:
20 ± 3˚C
Nominal and measured concentrations:
The toxicity control was used to evaluate toxicity of the test substance to the inoculum and was dosed with both the reference substance, sodium benzoate (10 mg C/L) and test substance 13.3 mg/L (10 mg C/L) for total of 20 mg carbon/L.
Key result
6 d
Dose descriptor:
Effect conc.:
13.3 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
other: inhibition of CO2 evolution
Remarks on result:
Toxicity test performed as part of a ready biodegradability CO2 evolution test performed according to OECD 301B and EU C.4-C.
Details on results:
At a test substance concentration of 13.3 mg/L (equivalent to 10 mg C/L) and a reference substance concentration of 10 mg C/L, the toxicity control attained >25% degradation by day 6, thereby confirming that the test substance did not exhibit an inhibitory effect on the sewage treatment micro-organisms used in the test (i.e., test substance and reference substance attained ≥ 25% degradation by Day 14 for the test substance to be considered as non-inhibitory).

Degradation behavior of the toxicity control was normal.

Validity criteria fulfilled:
IC content <5% (protocol ≤ 5%); CO2 emitted by controls <40 mgC/L (protocol <70 mg/L); difference replicates 4.4% (protocol ≤20 %); degradation positive control >60% at 6 d (protocol ≤14 d); degradation toxicity d 6, >25% (protocol ≥25%).
The test substance is considered as not toxic towards the inoculum at a concentration of 13.3 mg/L. Degradation in the toxicity flask was >25% after 6 days. The guideline indicates that the test item can be considered as toxic towards the inoculum if degradation in the toxicity flask is below 25% at 14 days.

Description of key information

The key study was a toxicity control conducted as part of a CO2 evolution test in accordance with OECD Guideline 301B. The test substance was shown to be non-inhibitory toward the inoculum at a concentration of 13.3 mg/L. Degradation in the toxicity flask was > 25% at 6 days.

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
13.3 mg/L

Additional information