Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-004-4 | CAS number: 50-03-3
Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocortisone 21-acetate
- EC Number:
- 200-004-4
- EC Name:
- Hydrocortisone 21-acetate
- Cas Number:
- 50-03-3
- Molecular formula:
- C23H32O6
- IUPAC Name:
- 11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): hydrocortisone-21-acetate (ZK 5192)
- Analytical purity: 99.4%
- Lot/batch No.: 20048246
- Expiration date of the lot/batch: Sep 1995
Constituent 1
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, domestic, non-adapted
- Duration of test (contact time):
- >= 28 d
Initial test substance concentrationopen allclose all
- Initial conc.:
- 10 mg/L
- Based on:
- test mat.
- Initial conc.:
- 20 mg/L
- Based on:
- test mat.
Results and discussion
% Degradation
- Parameter:
- % degradation (CO2 evolution)
- Value:
- > 70
- Sampling time:
- 28 d
- Details on results:
- At both test concentrations, the test compound was degraded to more than 70% at the end of the incubation period. 60% degradation was reached at day 11, which was less than 5 days after the start of the degradation (i.e.10% degradation). Therefore, hydrocortison acetate is ready biodegradable. The reference compound, sodium acetate, was degraded to more than 60% on day 8, fulfilling the validity criteria.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- More than 70% at the end of the incubation period
- Executive summary:
The aerobic biodegradation was studied in a CO2 evolution test according to OECD 301B. The test compound was incubated at concentrations of 10 and 20 mg/L over 28 days. At both concentrations, the test compound was degraded to more than 70% at the end of the incubation period. 60% degradation was reached at day 11, which was less than 5 days after the start of the degradation (i.e.10% degradation). Therefore, hydrocortison acetate is ready biodegradable. The reference compound, sodium acetate, was degraded to more than 60% on day 8, fulfilling the validity criteria.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
