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EC number: 944-482-9 | CAS number: -
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 9 October 2015 to 10 December 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- Deviations:
- no
- Remarks:
- Study is done according to Japanese guidelines which is equivalent to OECD TG 305
- GLP compliance:
- yes
- Radiolabelling:
- no
- Details on sampling:
- The test water of Level 1 and Level 2 were analyzed once before the first analysis of test fish and at the same time as analysis of test fish thereafter. One sample was analyzed at each sampling time.
Analysis of test fish was performed five times in test period. Four fish per treatment were taken out at each sampling time and divided into two groups (two fish per group) because one fish was not enough for the analytical sensitivity of the test item. Test fish analyses was carried out at intervals of more than 48 hours, and the final exposure period was 28 days. Analysis of control fish was performed before the experiment start and after the experiment completion. Four fish were taken out at the sampling time and divided into two groups, and analyzed individually. - Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION OF STANDARD SOLUTION:
1) Test water
Test sample (100 mg) was accurately weighes with an electronic analytical balance and dissolved in hexane to obtain 1000 mg/L solution of the test item. The 0.4 mg/L solution of the test item was then prepared from this solution by dilution with hexane. This solution was pretreated to prepare 20 ug/L standard solution.
2) Fish
Test sample (100 mg) was accurately weighed with an electronical analytical balance and dissolved in hexane to obtain 1000 mg/L solution of test item. 1 mg/L solution of the test item was then prepared from this solution by dilution with hexane. This solution was pretreated to prepare 20 ug/L standard solution. - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- SUPPLIER:
- CERI Kurume
CONDITIONS OF ACCLIMATIZATION:
The external disinfection was carried out in an aqueous solution containing OTC for fisheries (oxytetracycline hydrochloride, Kyoritsu Seikyaku) and sodium chloride (The Salt Industry Center of Japan). Thereafter fish were acclimatized in the following conditions:
Period: 52 days
Temperature: 25+/-2 ºC
Mortality during acclimatization was less than 5%.
- Length: 6.7 -8.3 cm
- Lot No.: TFC-150707
- Age: Yearling fish
FEEDING:
- Feed: Feed for colored carp
- Composition: Proteins content ≥ 30.0 %
- Lipid content: ≥ 4.0 %
- Manufacturer: Kyorin Food Corporation
- Feeding amount and interval: Amount corresponding to about 2 % of total body weight was fed once or twice a day in halves. The fish were starved for 24 hours before sampling. - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 28 d
- Test temperature:
- Level 1 24.1-24.8ºC
Level 2 24.1-24.6ºC
Control 24.4-24.8ºC - pH:
- Level 1 7.3, 7.3
Level 2 7.4, 7.3
Control 7.5, 7.5 - Dissolved oxygen:
- Level 1 6.7-7.1 mg/L
Level 2 6.8-7.1 mg/L
Control 7.4-7.6 mg/L - Details on test conditions:
- TEST SYSTEM:
- Test vessel: 70-L glass tank for volatile item (Level 1 and 2); Control 70-L glass tank
- Flow rate of test water: 0.04 mL/min for stock solution and 2000 mL/min for dilution water, 2880 L/day of test water, were supplied.
-Stock solution bottle: 0.5-L glass brown bottle (Level 1 and 2); 3-L glass brown bottle (Control); Frequency of renewal: 1 time/week (Level 1 and 2), 1 time/month (Control)
- No. of organisms (at the beginning of exposure): 28 (Level 1 and 2)
- No. of organisms (control): 14
OTHER TEST CONDITIONS:
- Time of irradiation with light: Artificial light of white fluorescent lamp (14 hours/day) - Nominal and measured concentrations:
- - Nominal:
Level 1: 10 µg/L
Level 2: 1 µg/L
- Measured:
Concentrations of test item were maintained >= 84% (Peak 1) and >= 86% (Peak 2) of nominal concentrations and the variations were within +/- 20% of the average measured concentrations. - Reference substance (positive control):
- yes
- Remarks:
- pentachlorophenol sodium salt
- Details on estimation of bioconcentration:
- The bioconcentration factor was calculated at steady-state.
- Lipid content:
- 3.43 %
- Time point:
- start of exposure
- Lipid content:
- 3.68 %
- Time point:
- end of exposure
- Key result
- Conc. / dose:
- 10 µg/L
- Temp.:
- 25 °C
- pH:
- 7.7
- Type:
- BCF
- Value:
- 117 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 7 d
- Calculation basis:
- steady state
- Remarks on result:
- other: corrected for 5% lipid
- Remarks:
- Based on the main constituent Peak 2
- Conc. / dose:
- 10 µg/L
- Temp.:
- 25 °C
- pH:
- 7.7
- Type:
- BCF
- Value:
- 86 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 7 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak 2
- Remarks:
- Main constituent, Conc.in environment / dose:0.899 µg/l
- Conc. / dose:
- 1 µg/L
- Temp.:
- 25 °C
- pH:
- 7.7
- Type:
- BCF
- Value:
- 16 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 7 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak 1
- Remarks:
- Conc.in environment / dose:9.46 µg/l
- Conc. / dose:
- 10 µg/L
- Temp.:
- 25 °C
- pH:
- 7.7
- Type:
- BCF
- Value:
- 83 L/kg
- Basis:
- whole body w.w.
- Time of plateau:
- 7 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak 2
- Remarks:
- Conc.in environment / dose:9.95 µg/l
- Details on results:
- Each concentration of the test item was maintained at more than 84 % (Peak 1) and more than 86% (Peak 2) of nominal concentrations. The variation of the concentrations of the test item was within ± 20 % of the average of the measured concentrations.
- Validity criteria fulfilled:
- yes
- Remarks:
- Water concentrations were maintained, BCF duplicates were within the 20% variability range as was the lipid content at the start and finish.
- Conclusions:
- The steady-state BCF value in Japanese carp (Cyprinus carpio) using the main constituent (5,5-Galbascone) and corrected for 5% lipid content is 117 L/kg.
- Executive summary:
A study on the bioaccumulation potential of the substance was performed equivalent to OECD TG 305 and GLP. In this study, whole-body steady-state bioconcentration factors (BCF) for Japanese carp (Cyprinus carpio) were examined at test concentrations of 1 µg/L and 10 µg/L in a flow-through system at 25oC. Each concentration of the test item in water was maintained at more than 84 % of each nominal concentration. The variation of the concentrations of the test item in fish was within ± 20 % of the average of the measured concentrations. Steady-state was reached within 7 days. At 1 and 10 ug/l the BCF for the main constituent is 86 l/kg. At 10 ug/l the BCF for the minor constituent is 16 l/kg, at 1 ug/l the BCF of the minor constituent was below the limit of detection in fish. The lipid content in the fish at the end of the test was 3.68% (and 3.43 at the start) and therefore the BCFss were normalized to 5% lipid content using the highest BCF value for the main constituent. This results in a BCF of 117 l/kg.
Reference
Results of test fish observation:
No abnormality in behavior or appearance was noted.
BCF at steady state
The variation of BCFs:
Peak | Level | After 21 days | After 24 days | After 28 days | Average of 3 results | |
1 Minor constituent: 3,3 Galbascone |
1 (10 ug/l) | Average BCF | 18.035 | 13.760 | 15.262 | 15.686 |
Variation rate from average of 3 results (%) | 14.975 | 12.273 | 2.7017 | |||
2 (1 ug/l) | Average BCF | 91.257 | 77.258 | 78.224 | 82.246 | |
Variation rate from average of 3 results (%) | 10.955 | 6.0654 | 4.8905 | |||
2 Major constituent: 5,5 Galbascone |
2 (10 ug/l) | Average BCF | 83.850 | 79.160 | 90.009 | 84.340 |
Variation rate from average of 3 results (%) | 0.58110 | 6.1410 | 6.7221 |
Peak 2 is the main constituent (5,5 Galbascone) and could be determined at both the 10 and 1 ug/l. Peak 1 could only de determined at the 10 ug/l level. The BCFs steady states are within the +/- 20% of the average for these days' BCFs and thererfore acceptable: after 21, 24 and 28 days from the initiation of exposure were 3 -15% (peak 1 in Level 1), 5 -11% (Peak 2 in Level 1) and 1 -7% (Peak 2 in Level 2)
Description of key information
A study on the bioaccumulation potential of the substance was performed equivalent to OECD TG 305 and GLP. In this study, whole-body steady-state bioconcentration factors (BCF) for Japanese carp (Cyprinus carpio) were examined at test concentrations of 1 µg/L and 10 µg/L in a flow-through system at 25oC. Each concentration of the test item in water was maintained at more than 84 % of each nominal concentration. The variation of the concentrations of the test item in fish was within ± 20 % of the average of the measured concentrations. Steady-state was reached within 7 days. At 1 and 10 ug/l the BCF for the main constituent is 86 l/kg. At 10 ug/l the BCF for the minor constituent is 16 l/kg, at 1 ug/l the BCF of the minor constituent was below the limit of detection in fish. The lipid content in the fish at the end of the test was 3.68% (and 3.43 at the start) and therefore the BCFss were normalized to 5% lipid content using the highest BCF value for the main constituent. This results in a BCF of 117 l/kg.
Key value for chemical safety assessment
- BCF (aquatic species):
- 117 L/kg ww
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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