Registration Dossier
Registration Dossier
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: 606-744-8 | CAS number: 213464-77-8
- 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 and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: sediment simulation testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 308 (Aerobic and Anaerobic Transformation in Aquatic Sediment Systems)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SETAC, Part 1, Section 8.2 “Aerobic aquatic degradation”, March 1995
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- [14C-5-pyrimidinyl]IR5878 Lot 208
Specific radioactivity: 267117 dpm/µg
120.323 µCi/mg
4.452 MBq/mg
Radiochemical purity: > 97%
Unlabelled IR5878
Batch number: 20698/27
Purity: > 97% - Radiolabelling:
- yes
- Inoculum or test system:
- natural water / sediment: freshwater
- Details on source and properties of surface water:
- The degradation of 14C-IR5878 has been studied in two aquatic systems, named Pond system and River system, over a 155 days period.
- Details on source and properties of sediment:
- The degradation of 14C-IR5878 has been studied in two aquatic systems, named Pond system and River system, over a 155 days period.
- Initial conc.:
- >= 75 other: g/ha
- Key result
- Compartment:
- natural water: freshwater
- DT50:
- >= 10 d
- Temp.:
- 20 °C
- Remarks on result:
- other: Pond and River
- Key result
- Compartment:
- natural sediment: freshwater
- DT50:
- >= 41 d
- Temp.:
- 20 °C
- Remarks on result:
- other: Pond
- Key result
- Compartment:
- natural sediment: freshwater
- DT50:
- >= 24 d
- Temp.:
- 20 °C
- Remarks on result:
- other: River
- Key result
- Compartment:
- natural water / sediment: freshwater
- DT50:
- >= 27 d
- Temp.:
- 20 °C
- Remarks on result:
- other: Pond
- Key result
- Compartment:
- natural water / sediment: freshwater
- DT50:
- >= 20 d
- Temp.:
- 20 °C
- Remarks on result:
- other: River
- Transformation products:
- yes
- Details on transformation products:
- The metabolite S12 (IR7825) reached a maximum of 77.10 % AR in the river system. No other compounds were found to exceed 10% AR.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The degradation of [14C-5-pyrimidinyl]IR5878 has been studied in two aquatic systems over a 155 days period.
Several degradation products were separated, and S12 (IR7825) exceeded 10% AR.
DT50lab were 10 days for surface water in both pond and river system.
DT50lab were 41 and 24 days for sediment in pond and river system respectively.
DT50lab were 27 and 20 days for whole system in pond and river system respectively. - Executive summary:
The degradation of [14C-5-pyrimidinyl]IR5878 has been studied in two aquatic systems, named Pond system and River system, over a 155 days period.
Several degradation products were separated, and S12 (IR7825) exceeded 10% AR. DT50labwere 10 days for surface water in both pond and river system. DT50labwere 41 and 24 days for sediment in pond and river system, respectively. DT50labwere 27 and 20 days for whole system in pond and river system, respectively.
Reference
Findings
The radioactivity in the surface water decreased from 99.22% of the applied radioactivity (AR) to 7.94% AR (pond system) and from 99.53% AR to 19.88% AR (river system).
The radioactivity in sediment (extractable + bound) increased from 19.22% AR to 93.21% AR (pond system) and from 15.43% AR to 69.76% AR (river system).
The radioactivity in the pond sediment extracts increased to a maximum of 70.71% AR at 91 days, then it decreased to 63.89% AR at 155 days. The radioactivity in the river sediment extracts increased to 62.17% AR at 91 days, then it decreased to 54.27% AR at 155 days.
14C-IR5878 degraded in both water-sediment systems, and its amount accounted for 2.44% AR and 0.77% AR respectively in the pond system and in the river system at the last sampling time.
DT50laband DT90labvalues (Disappearance Time for 50% and 90% of the starting concentration) are summarised in Table 7.8-8.
Table 7.8-8 DT50laband DT90labvalues for IR5878
|
DT50lab |
DT90lab |
r2 |
|||
|
Pond |
River |
Pond |
River |
Pond |
River |
Surface water |
10 days |
10 days |
33 days |
32 days |
0.902 |
0.939 |
Sediment |
41 days |
24 days |
136 days |
80 days |
0.926 |
0.862 |
Whole system |
27 days |
20 days |
91 days |
66 days |
0.902 |
0.953 |
Seven compounds were found in the surface water and in the sediment extracts: unchanged14C-IR5878 and six degradation compounds.
The main degradation compounds were S12 and the fraction S11: S12 reached amounts higher than 60% AR, the fraction S11 was constituted by a pool of 6-10 compounds, none of which reached amounts higher than 5% AR. The other minor degradation compounds (S9, S13, S15, S16) never reached amounts higher than 10% AR.
Table 7.8-9 Radioactivity distribution of14C-IR5878 and its main degradation compounds in surface water
Time point |
Pond system (Compounds % AR) |
River system (Compounds % AR) |
||||
(days) |
S3 (IR5878) |
S11 |
S12 |
S3 (IR5878) |
S11 |
S12 |
0 |
94.43 |
< dl |
2.68 |
93.48 |
0.60 |
2.82 |
3 |
68.11 |
0.76 |
5.81 |
72.58 |
0.60 |
4.27 |
7 |
56.17 |
2.83 |
6.48 |
60.62 |
1.23 |
5.06 |
15 |
36.54 |
8.51 |
5.33 |
42.03 |
4.40 |
6.31 |
31 |
23.95 |
7.62 |
7.70 |
27.43 |
10.38 |
6.81 |
45 |
2.68 |
3.52 |
15.36 |
4.81 |
6.95 |
27.32 |
60 |
< dl |
4.16 |
8.90 |
0.87 |
5.42 |
26.60 |
91 |
< dl |
2.90 |
6.01 |
< dl |
7.49 |
22.39 |
120 |
0.46 |
2.71 |
3.44 |
< dl |
1.86 |
14.08 |
155 |
0.42 |
1.77 |
3.04 |
< dl |
1.68 |
14.21 |
dl = detection limit = 0.39% AR and 0.40% AR only for 45 days
Table 7.8-10 Radioactivity distribution of14C-IR5878 and its main degradation compounds in sediment
Time point |
Pond system (Compounds % AR) |
River system (Compounds % AR) |
||||
(days) |
S3 (IR5878) |
S11 |
S12 |
S3 (IR5878) |
S11 |
S12 |
0 |
nd |
nd |
nd |
nd |
nd |
nd |
3 |
11.39 |
<dl |
3.32 |
12.84 |
< dl |
2.07 |
7 |
12.62 |
0.27 |
7.05 |
22.08 |
0.40 |
4.58 |
15 |
15.74 |
2.29 |
8.91 |
22.98 |
2.49 |
8.68 |
31 |
18.69 |
3.95 |
16.15 |
24.44 |
5.51 |
11.93 |
45 |
12.47 |
2.79 |
41.65 |
25.66 |
5.85 |
14.09 |
60 |
6.13 |
2.91 |
51.22 |
4.79 |
3.32 |
50.51 |
91 |
4.33 |
2.72 |
56.77 |
2.60 |
2.77 |
51.70 |
120 |
3.27 |
1.99 |
53.69 |
1.16 |
2.13 |
49.28 |
155 |
2.02 |
2.44 |
53.99 |
0.77 |
1.49 |
47.91 |
nd = Not determined
dl = detection limit = 0.13% AR
Table 7.8-11 Radioactivity distribution of14C-IR5878 and its main degradation compounds in whole system
Time point |
Pond system (Compounds % AR) |
River system (Compounds % AR) |
||||
(days) |
S3 (IR5878) |
S11 |
S12 |
S3 (IR5878) |
S11 |
S12 |
0 |
94.43 |
< dl |
2.68 |
93.48 |
0.60 |
2.82 |
3 |
79.50 |
0.76 |
9.14 |
85.42 |
0.60 |
6.34 |
7 |
68.79 |
3.10 |
13.53 |
82.70 |
1.63 |
9.64 |
15 |
52.28 |
10.80 |
14.25 |
65.01 |
6.89 |
14.99 |
31 |
42.64 |
11.57 |
23.85 |
51.87 |
15.89 |
18.74 |
45 |
15.14 |
6.31 |
57.01 |
30.46 |
12.79 |
41.41 |
60 |
6.13 |
7.08 |
60.12 |
5.65 |
8.74 |
77.10 |
91 |
4.33 |
5.62 |
62.78 |
2.60 |
10.26 |
74.08 |
120 |
3.73 |
5.00 |
57.14 |
1.16 |
3.99 |
63.36 |
155 |
2.44 |
4.21 |
57.03 |
0.77 |
3.17 |
62.12 |
The non-extractable radioactivity (bound residue) increased to 29.32% AR and to 15.49% AR in pond and river system, respectively.
The fractionation of organic matter was carried on the samples when the bound residue was higher than 20%. In pond system samples incubated 155 days humin fraction accounted for 19.49% AR, fulvic acid fraction for 6.48% AR and humic acid fraction for 2.38% AR.
The radioactivity in the14C-CO2traps was lower than the detection limit in both the systems till 31 days, then it was detected at amounts ranging from 1.31% AR and 1.98% AR in pond system and from 0.10% AR to 1.01% AR in river system.
The Mass Balance was always higher than 95% AR in the pond system, where it ranged from 95.00% AR to 103.36% AR and it was always higher than 90% AR in the river system, where it ranged from 90.65% AR to 103.70% AR.
Table 7.8-12 14C-Mass Balance
Time point (days) |
Pond system |
River system |
||||||
|
Surface water |
Sediment |
CO2 |
Total |
Surface water |
Sediment |
CO2 |
Total |
0 |
99.22 |
- |
na |
99.22 |
99.53 |
<dl |
na |
99.53 |
3 |
78.27 |
19.22 |
<dl |
97.49 |
80.61 |
15.43 |
<dl |
96.04 |
7 |
69.30 |
26.74 |
<dl |
96.04 |
71.11 |
29.65 |
<dl |
100.76 |
15 |
56.81 |
44.88 |
<dl |
101.69 |
59.15 |
40.25 |
<dl |
99.40 |
31 |
44.36 |
55.62 |
<dl |
99.98 |
49.63 |
46.85 |
<dl |
96.48 |
45 |
24.24 |
76.60 |
1.35 |
102.19 |
43.53 |
55.22 |
0.85 |
99.60 |
60 |
16.29 |
83.10 |
1.34 |
100.73 |
36.53 |
67.07 |
0.10 |
103.70 |
91 |
12.83 |
89.22 |
1.31 |
103.36 |
30.59 |
68.45 |
0.77 |
99.81 |
120 |
9.52 |
83.50 |
1.98 |
95.00 |
21.92 |
69.24 |
0.86 |
92.02 |
155 |
7.94 |
93.21 |
1.54 |
102.69 |
19.88 |
69.76 |
1.01 |
90.65 |
Description of key information
The degradation of [14C-5-pyrimidinyl]IR5878 has been studied in two aquatic systems, named Pond system and River system, over a 155 days period.
Several degradation products were separated, and S12 (IR7825) exceeded 10% AR. DT50labwere 10 days for surface water in both pond and river system. DT50labwere 41 and 24 days for sediment in pond and river system, respectively. DT50labwere 27 and 20 days for whole system in pond and river system, respectively.
Key value for chemical safety assessment
- Half-life in freshwater:
- 10 d
- at the temperature of:
- 20 °C
- Half-life in freshwater sediment:
- 41 d
- at the temperature of:
- 20 °C
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.
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.
