Registration Dossier
Registration Dossier
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EC number: 270-128-1 | CAS number: 68411-46-1
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: simulation testing on ultimate degradation in surface water
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Experimental starting date (Preparation of the test system) 13 April 2021 Start of exposure (day 0) 19 April 2021 Experimental completion date expected by February 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The registered substance Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene is a UVCB substance, which contains several constituents. Bis(4-tert-butylphenyl)amine is one of these constituents.
The test item, for the OECD 309 is labelled Bis(4-tert-butylphenyl)amine,
CAS 4627-22-9. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 309 (Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- radiolabeled test substance:
Name of test substance: 14C-Bis(4-tert-butylphenyl)amine
Test substance No.: 18/0435-1
Batch No: 1254-1101
Chemical purity: 97.3 %
Radiochemical Purity: 98.7 %
Identity: confirmed
Specific activity: 72.8 MBq/g
Specific activity of AI: 7.8 MBq/mg
Concentration of AI:
AI=active ingredient (test item) 9.21 mg/g
Homogeneity: Homogenous
Solvent: Acetonitrile
IUPAC name: Bis(4-t-butylphenylamin)
unlabeled test substance:
Name of unlabelled test substance: Bis(4-tert-butylphenyl)amine
Test substance No: 21/0138-1
Batch No: HDMPF
CAS No: 4627-22-9
Purity: 93.9 % (Certificate of Analysis)
Content: not indicated
Identity: confirmed (Certificate of Analysis)
Homogeneity: given - Radiolabelling:
- yes
- Oxygen conditions:
- aerobic (low dissolved oxygen)
- Inoculum or test system:
- effluent/surface water mixture, non-adapted treated
- Remarks:
- study ongoing, details available in final report
- Details on source and properties of surface water:
- study ongoing, details available in final report
- Details on inoculum:
- study ongoing, details available in final report
- Duration of test (contact time):
- 90 d
- Details on study design:
- study ongoing, details available in final report
- Test performance:
- study ongoing, details available in final report
- Remarks on result:
- other: study ongoing, details available in final report
- Key result
- Remarks on result:
- other: study ongoing, details available in final report
- Key result
- Remarks on result:
- other: study ongoing, details available in final report
- Transformation products:
- not specified
- Remarks:
- study ongoing, details available in final report
- Details on transformation products:
- study ongoing, details available in final report
- Details on results:
- study ongoing, details available in final report
- Results with reference substance:
- study ongoing, details available in final report
- Validity criteria:
- study ongoing, details available in final report
- Observed value:
- study ongoing, details available in final report
- Validity criteria fulfilled:
- yes
- Remarks:
- study ongoing, details available in final report
- Conclusions:
- study ongoing, details available in final report
- Executive summary:
study ongoing, details available in final report
Reference
study ongoing, details available in final report
Description of key information
An OECD 309 study is still ongoing. The delay is caused by analytical difficulties.
Key value for chemical safety assessment
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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