Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 200-466-7 | CAS number: 60-27-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: inherent biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21.11.2002 - 02.12.2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- other: DIN EN ISO 9 888, replaces DIN EN 29 888
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 302 B (Inherent biodegradability: Zahn-Wellens/EMPA Test)
- GLP compliance:
- not specified
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum/activated sludge: sewage treatment plant Trostberg
- Method of cultivation: aerobic cultivation, dry solids: 4.9 g/L - Duration of test (contact time):
- 11 d
- Initial conc.:
- 953 mg/L
- Based on:
- test mat.
- Initial conc.:
- ca. 460 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- DOC removal
- Details on study design:
- TEST CONDITIONS
- Composition of medium: activated sludge, nutrient medium, deionized water
- Additional substrate: nutrient medium (according to DIN EN 9888)
- Test temperature: 20-25°C
- pH adjusted: yes (to pH 7 +/- 0.5 if required)
TEST SYSTEM
- Culturing apparatus: brown glass vessels (2 L)
- Number of culture flasks/concentration: 1
- Method used to create aerobic conditions: aeration and agitation
SAMPLING
- Sampling frequency: at least every 4 days
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes (1 replicate)
- Abiotic sterile control: yes (HgCl2 added, 1 replicate) - Reference substance:
- other: no reference substance used
- Preliminary study:
- Not applicable.
- Test performance:
- No unusual observations during test affecting results.
- Parameter:
- % degradation (DOC removal)
- Value:
- 93
- Sampling time:
- 11 d
- Details on results:
- No further details reported.
- Results with reference substance:
- Not applicable, no reference substance tested.
- Validity criteria fulfilled:
- not applicable
- Remarks:
- no test results with reference substance available (e.g. aniline, ethylene glycol)
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Creatinine is readily biodegradable under the conditions of the test.
- Executive summary:
Creatinine was tested for its biodegradability according to the German Guideline DIN EN ISO 9888 which is similiar to OECD 302 B (Zahn-Wellens-Test) at an initial concentration of ca. 460 mg DOC/L at a temperature of 20 -25 °C for 11 days. Biodegradation was followed by measurements of DOC removal.
Under the conditions of the test, 93 % degradation could be observed after 11 days. Also the biodegradation was within the 10 day window and therefore Creatinine is regarded as readily biodegradable.
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.10.2005 - 21.12.2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 E (Ready biodegradability: Modified OECD Screening Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-B (Determination of the "Ready" Biodegradability - Modified OECD Screening Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility (under test conditions): 90 g/L (20 °C)
- Stability of test material at room temperature: stable - Oxygen conditions:
- aerobic
- Inoculum or test system:
- sewage, predominantly domestic, non-adapted
- Details on inoculum:
- Inoculum from the effluent of the sewage treatment works A-2500 Baden, which waste-water catchment is predominantly domestic, was collected. On arrival in the laboratory, the sample was aerated by means of filtered compressed air for about 45 minutes before used for the study.
The inoculum was not acclimatised or adapted to Creatinine before exposure to the test substance in this study. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 40 mg/L
- Based on:
- DOC
- Parameter followed for biodegradation estimation:
- DOC removal
- Details on study design:
- TEST CONDITIONS
- Composition of medium: see "any other information on material and methods"
- Test temperature: 22.0 +/- 0.6 °C.
- pH: 6.26 - 7.56
- pH adjusted: no
- Continuous darkness: yes - Reference substance:
- benzoic acid, sodium salt
- Preliminary study:
- no data
- Test performance:
- see "any other information on materials and methods"
- Key result
- Parameter:
- % degradation (DOC removal)
- Value:
- 96.1
- Sampling time:
- 28 d
- Details on results:
- see "any other information on results"
- Results with reference substance:
- The plateau of biodegradation was reached on Day 2 and the degradation of the positive control substance sodium benzoate exceeded the pass level of 70 % within 14 days.
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The test substance Creatinine with a nominal concentration of 40 mg DOC/L was degraded by 96.1 % after 28 days of incubation at 22 +/- 0.6 °C. The biodegradation occured within a 10-d window according to the Guideline. Therefore Creatinine can be classified as readily biodegradable.
- Executive summary:
The ready biodegradability of Creatinine was determined by the measurement of DOC (dissolved organic carbon) at frequent intervals over a 28 day period. The methode used was that described in Part C.4-B of the EC Commission Directive 92/69/EEC and in the OECD Guideline 301 E.
The reference substance sodium benzoate was degraded by 97.7 % within 14 days. Degradation in the toxicity control, which contained sodium benzoate and the test substance, was not indicative of an inhibition of the microbial activity by the test substance. The test substance Creatinine with a nominal concentration of 40 mg DOC/L was degraded by 96.1 % after 28 days of incubation at 22 +/- 0.6 °C. The biodegradation occured within a 10-d window according to the Guidelines.
According to the Guidelines a substance giving a result greater than 70 % loss of DOC in a 10 -d window within 28 days is regarded as readily biodegradable. Therefore Creatinine can be classified as readily biodegradable.
Referenceopen allclose all
Table 2: DOC removal [%]
Date |
Day |
DOC removal [%] |
||
Test vessel a |
Test vessel b |
Control vessel |
||
21.11.2002 |
0.125 |
|
|
|
22.11.2002 |
1 |
5 |
8 |
64 |
25.11.2002 |
4 |
84 |
4 |
85 |
28.11.2002 |
7 |
93 |
- |
94 |
02.12.2002 |
11 |
88 |
3 |
100 |
Blank corrected data of the DOC determination is presented in table 2 and percentage biodegradation is listed in table 3.
Table 2: Blank-corrected DOCs (mg/L)
Day |
test substance |
positive control PK5 |
toxicity control TK6 |
|
A3 |
A4 |
|||
0 |
40.01 |
39.33 |
20.74 |
58.94 |
2 |
39.83 |
39.69 |
1.52 |
40.81 |
4 |
12.73 |
12.68 |
1.15 |
13.24 |
7 |
11.84 |
12.99 |
0.89 |
11.03 |
10 |
11.98 |
13.00 |
1.19 |
10.36 |
14 |
10.57 |
11.31 |
0.48 |
8.81 |
17 |
10.23 |
10.73 |
1.26 |
8.37 |
21 |
2.44 |
8.94 |
1.22 |
2.12 |
24 |
1.88 |
1.53 |
1.08 |
2.08 |
28 |
1.92 |
1.22 |
0.57 |
1.52 |
Table 3: Percentage biodegradation
Day |
Test substance |
mean |
positive control PK5 |
toxicity control TK6 |
|
A3 |
A4 |
||||
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0.46 |
-0.91 |
-0.23 |
92.67 |
30.76 |
4 |
68.18 |
67.77 |
67.98 |
94.46 |
77.54 |
7 |
70.41 |
66.98 |
68.69 |
95.70 |
81.29 |
10 |
70.05 |
66.95 |
68.50 |
94.24 |
82.42 |
14 |
73.59 |
71.24 |
72.42 |
97.71 |
85.06 |
17 |
74.44 |
72.73 |
73.58 |
93.92 |
85.80 |
21 |
93.91 |
77.27 |
85.59 |
94.12 |
96.41 |
24 |
95.31 |
96.12 |
95.72 |
94.81 |
96.48 |
28 |
95.20 |
96.90 |
96.05 |
97.25 |
97.42 |
1) Test substance
Creatinine degraded by 96.1 % within 28 days. The degradation occurred within a 10 -d window as defined by the Guidelines. The 10 -d window started at about Day 3. 70 % degradation was exceeded at approx. Day 13, i.e. within the 10 -d window.
2) Positive control
The plateau of biodegradation was reached on Day 2 and the degradation of the positive control substance sodium benzoate exceeded the pass level of 70 % within 14 days.
3) Toxicity control
Degradation in the toxicity control, which contained sodium benzoate and the test substance, was not indicative of an inhibition of the microbial activity by the test substance.
4) Abiotic degradation
On Day 0, the DOC concentration was between 40.58 and 40.61 mg/L and on Day 28 between 39.58 and 39.46 mg/L, therefore no significant degradation to inorganic carbon occured in the abiotic sterile control.
5) Adsorption control
On Day 0, the DOC concentration was between 40.37 and 42.29 mg/L and on Day 28 between 39 .08 and 39.63 mg/L, therefore no adsorption of the test substance to the inoculum occured.
Description of key information
Two tests were performed to assess the biodegradability of Creatinine.
The first methode used was that described in Part C.4-B of the EC Commission Directive 92/69/EEC and in the OECD Guideline 301 E.
The second was according to the German Guideline DIN EN ISO 9888 which
is similiar to OECD 302 B (Zahn-Wellens-Test).
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
Additional information
Two tests were performed to assess the biodegradability of Creatinine. The first methode used was that described in Part C.4-B of the EC Commission Directive 92/69/EEC and in the OECD Guideline 301 E. The second was according to the German Guideline DIN EN ISO 9888 which is similiar to OECD 302 B (Zahn-Wellens-Test).
In the first test Creatinine (with a nominal concentration of 40 mg DOC/L) was degraded by 96.1 % after 28 days of incubation at 22 +/- 0.6 °C. Under the conditions of the second test 93 % degradation could be observed after 11 days. Also the biodegradation occured within a 10-d window according to the Guideline and therefore Creatinine is regarded as readily biodegradable.
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.