Registration Dossier

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to
Guideline:
EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test)
Version / remarks:
Cited as Directive 87/302/EEC, part C, p. 118 (Biodegradation: Activated sludge respiration inhibition test)
GLP compliance:
yes
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
activated sludge
Water media type:
freshwater
Total exposure duration:
3 h
Details on test conditions:
Type: aquatic
Duration:
3 h
Dose descriptor:
NOEC
Effect conc.:
> 350 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
> 350 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Endpoint:
activated sludge respiration inhibition testing
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance.
Adequacy of study:
key study
Justification for type of information:
Please refer to the analogue justification attached to chapter 13.
Reason / purpose:
read-across source
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
> 350 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks on result:
other: Source, RA-A, CAS 103-23-1
Duration:
3
Dose descriptor:
NOEC
Effect conc.:
> 350 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks on result:
other: Source, RA-A, CAS 103-23-1

Description of key information

EC50 (3 h) was >350 mg/L (read across)

 

Key value for chemical safety assessment

EC50 for microorganisms:
350 mg/L

Additional information

Data on the acute toxicity of the target substance (EC 943-330-9) to fish are not available. The assessment was therefore based on a study conducted with the analogue substance Bis(2-ethylhexyl) adipate (CAS 103-23-1) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Further justification is given within the overall summary chapter 6.1 and within the analogue justification in IUCLID section 13.

The toxicity of the source substance Bis(2-ethylhexyl) adipate on microorganisms was tested in an respiration inhibition test according to EU Method C.11 (GLP). No effect was observed after 3 h up to a concentration of 350 mg/L. The determined EC50 (3 h) was >350 mg/L.

Based on the results of the read across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) toxic effects of the target substance (EC 943-330-9) to microorganisms are not expected. The degradation process in an STP is not considered to be inhibited.