Registration Dossier
Registration Dossier
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EC number: 943-330-9 | CAS number: -
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- 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
- 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 for cross-reference:
- 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
Referenceopen allclose all
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.
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