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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-350-3 | CAS number: -
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:
- August - December 2006
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: Test Method Relating to New Chemical Substances
(Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No 2, Kanapokihatsu No 031121002, November 21, 2003, latest revision April 1, 2005) - GLP compliance:
- yes
- Vehicle:
- yes
- Remarks:
- HCO-40
- Details on preparation of test solutions, spiked fish food or sediment:
- Feed solutions were prepared as follows:
- High concentration level: 10 g of test substance was dissolved with 200 mL 50% (w/v) HCO-40/tetrahydrofuran. Tetrahydrofuran ws added and the solution was dissolved and diluted to 250 mL to produce Feed solution 1. Feed solution 1 contained 40000 mg/L test substance and 400000 mg/L HCO-40.
- Low concentration level: 25 mL of Feed solution 1 was diluted with tetrahydrofuran to 250 mL to produce Feed solution 2. Feed solution 2 contained 4000 mg/L test substance and 40000 mg/L HCO-40.
- Control: 200 mL 50% (w/v) HCO-40/tetrahydrofuran was diluted to 250 mL with tetrahydrofuran to produce a HCO-40 concentration of 400000 mg/L.
- Feed solutions were renewed at 11 day intervals.
Test solutions were prepared by diluting feed solutions with a metering pump with dilution water and then poured into each test chamber. Test concentrations were as follows:
- High concentration level: 1 mg/L (HCO-40: 10 mg/L; tetahydrofuran 14 ppm)
- Low concentration level: 0.1 mg/L (HCO-40: 1 mg/L; tetahydrofuran 24 ppm)
- Control: 0 mg/L (HCO-40: 10 mg/L; tetahydrofuran 15 ppm) - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Source: Niikura Fish Farm, 1217, Shimoya, Isehara-city, Kanagawa, Japan
- Age at study initiation: Approximately 1 year
- Length at study initiation: 8 ± 4 cm
- Weight at study initiation: 5 g
- Health status: At the start of acclimation, visual observation was made and abnormal fish were removed. The remaining normal fish were reared in an aquarium with flowing water. During the acclimation period, fish were kept without receiving medicine in the aquarium.
ACCLIMATION
- Acclimation period: >= 2 weeks
- Type and amount of food: Babygold(R) from Kyorin, given at 2% of the fish weight
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): <5% during the 1 week prior to testing - Route of exposure:
- aqueous
- Test type:
- semi-static
- Test temperature:
- 24 ± 2°C
- pH:
- 6.0-8.5
- Dissolved oxygen:
- >=60% of saturation
- Nominal and measured concentrations:
- Nominal
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 195 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak A
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 111 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak B
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 79 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak C
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 42 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak D
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 31 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak E
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- <= 17 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak F
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 464 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak A
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 395 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak B
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 324 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak C
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 186 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak D
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- ca. 94 - ca. 162 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak E
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 53 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak F
- Validity criteria fulfilled:
- yes
- Conclusions:
- At 0.1 mg/L, BCFs of 53-464 were determined. At 1 mg/L, BCFs of 17-195 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Executive summary:
The bioaccumulation of R04-5135 was investigated in Cyprinus carpio. At 0.1 mg/L, BCFs of 53-464 were determined. At 1 mg/L, BCFs of 17-195 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across hypothesis is based on an analogue approach. Within this approach, it is assumed that, based on structural similarity, the source and target substances will display similar toxicological properties. Of the analogue approaches detailed in the RAAF guidance document, Scenario 2 “Assessment of different compounds that have qualitatively similar properties” is considered the most appropriate hypothesis for this read-across. AEs specific to this scenario are considered within the attached read-across justification report.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Both the source and target are long-chain alkenyl succinimides. Both the source and target substances are long-chain alkenyl succinimides. The source substance is suspected to contain lactone acids and ketone acids that are not present in the target substance. However, these substances are not expected to result in a significant difference in aquatic toxicity between the source and target substances.
3. ANALOGUE APPROACH JUSTIFICATION
The source and target substances are highly consistent in their toxicological profiles, with both the source and target demonstrating no toxicity to aquatic organisms. It must be acknowledged that there are differences in the biodegradation of the source and target substances; the target is readily biodegradable, but the source substance is not. However, the lower biodegradation of the source substance can be explained by the longer C chain length of the source substance and the use of TG 301C vs. 301F. It is well known that 301C is the most stringent of the ready biodegradability guidelines and produces the most conservative results. As degradation of the target will result in less substance being available for bioaccumulation, it is considered that bioaccumulation assessments based on the more persistent source substance will be conservative in nature. As there is no quantitative difference in toxicity of the source and target substances, it is considered unlikely degradation products of the target substance will have any influence on toxicity to aquatic organisms. Therefore, this difference is not anticipated to affect the use of the source substance for read across.
4. DATA MATRIX
See attached read-across justification report. - Reason / purpose for cross-reference:
- read-across source
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 195 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak A
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 111 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak B
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 79 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak C
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 42 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak D
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- 31 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak E
- Conc. / dose:
- 1 mg/L
- Type:
- BCF
- Value:
- <= 17 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak F
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 464 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak A
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 395 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak B
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 324 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak C
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 186 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak D
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- ca. 94 - ca. 162 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak E
- Conc. / dose:
- 0.1 mg/L
- Type:
- BCF
- Value:
- 53 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak F
- Validity criteria fulfilled:
- yes
- Conclusions:
- At 0.1 mg/L, BCFs of 53-464 were determined. At 1 mg/L, BCFs of 17-195 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Executive summary:
This read-across hypothesis is based on an analogue approach. Within this approach, it is assumed that, based on structural similarity, the source and target substances will display similar toxicological properties. The source and target substances are highly consistent in their toxicological profiles, with both the source and target demonstrating no toxicity to aquatic organisms. Differences between the source and target substances are not anticipated to affect the use of the source substance for read across.
The bioaccumulation of R04 -5135 was investigated in Cyprinus carpio. At 0.1 mg/L, BCFs of 53 -464 were determined. At 1 mg/L, BCFs of 17-195 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January - July 2017
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: Test Method Relating to New Chemical Substances
(Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No 2, Kanapokihatsu No 031121002, November 21, 2003, latest revision Nov 20, 2006) - GLP compliance:
- yes
- Vehicle:
- yes
- Remarks:
- HCO-40
- Details on preparation of test solutions, spiked fish food or sediment:
- Test concentrations were as follows:
- Test concentration: 0.02 mg/L (HCO-40: 0.2 mg/L; tetahydrofuran 24 ppm)
- Control: 0 mg/L (HCO-40: 0.2 mg/L; tetahydrofuran 25 ppm) - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Source: Niikura Fish Farm, 1217, Shimoya, Isehara-city, Kanagawa, Japan
- Age at study initiation: Less than 1 year
- Length at study initiation: 8 ± 4 cm
- Weight at study initiation: 5 g
- Health status: At the start of acclimation, visual observation was made and abnormal fish were removed. The remaining normal fish were reared in an aquarium with flowing water. During the acclimation period, fish were kept without receiving medicine in the aquarium.
ACCLIMATION
- Acclimation period: >= 2 weeks
- Type and amount of food: Babygold(R) from Kyorin, given at 2% of the fish weight
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): <5% during the 1 week prior to testing - Route of exposure:
- aqueous
- Test type:
- semi-static
- Test temperature:
- 24 ± 2°C
- pH:
- 6.0-8.5
- Nominal and measured concentrations:
- Nominal
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 492 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak A
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 450 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak B
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 455 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak C
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 258 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other: Peak D
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Remarks on result:
- not determinable
- Remarks:
- Peak E
- Validity criteria fulfilled:
- yes
- Conclusions:
- At 0.02 mg/L, BCFs of 258-492 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Executive summary:
The bioaccumulation of R04-5135 was investigated in Cyprinus carpio. At 0.02 mg/L, BCFs of 258-492 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across hypothesis is based on an analogue approach. Within this approach, it is assumed that, based on structural similarity, the source and target substances will display similar toxicological properties. Of the analogue approaches detailed in the RAAF guidance document, Scenario 2 “Assessment of different compounds that have qualitatively similar properties” is considered the most appropriate hypothesis for this read-across. AEs specific to this scenario are considered within the attached read-across justification report.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Both the source and target are long-chain alkenyl succinimides. Both the source and target substances are long-chain alkenyl succinimides. The source substance is suspected to contain lactone acids and ketone acids that are not present in the target substance. However, these substances are not expected to result in a significant difference in aquatic toxicity between the source and target substances.
3. ANALOGUE APPROACH JUSTIFICATION
The source and target substances are highly consistent in their toxicological profiles, with both the source and target demonstrating no toxicity to aquatic organisms. It must be acknowledged that there are differences in the biodegradation of the source and target substances; the target is readily biodegradable, but the source substance is not. However, the lower biodegradation of the source substance can be explained by the longer C chain length of the source substance and the use of TG 301C vs. 301F. It is well known that 301C is the most stringent of the ready biodegradability guidelines and produces the most conservative results. As degradation of the target will result in less substance being available for bioaccumulation, it is considered that bioaccumulation assessments based on the more persistent source substance will be conservative in nature. As there is no quantitative difference in toxicity of the source and target substances, it is considered unlikely degradation products of the target substance will have any influence on toxicity to aquatic organisms. Therefore, this difference is not anticipated to affect the use of the source substance for read across.
4. DATA MATRIX
See attached read-across justification report. - Reason / purpose for cross-reference:
- read-across source
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 492 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak A
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 450 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak B
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 455 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak C
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Value:
- 258 L/kg
- Basis:
- whole body w.w.
- Calculation basis:
- steady state
- Remarks on result:
- other:
- Remarks:
- Peak D
- Conc. / dose:
- 0.02 mg/L
- Type:
- BCF
- Remarks on result:
- not determinable
- Remarks:
- Peak E
- Validity criteria fulfilled:
- yes
- Conclusions:
- At 0.02 mg/L, BCFs of 258-492 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
- Executive summary:
This read-across hypothesis is based on an analogue approach. Within this approach, it is assumed that, based on structural similarity, the source and target substances will display similar toxicological properties. The source and target substances are highly consistent in their toxicological profiles, with both the source and target demonstrating no toxicity to aquatic organisms. Differences between the source and target substances are not anticipated to affect the use of the source substance for read across.
The bioaccumulation of R04-5135 was investigated in Cyprinus carpio. At 0.02 mg/L, BCFs of 258-492 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
Referenceopen allclose all
Description of key information
The bioaccumulation of R04-5135 was investigated in Cyprinus carpio. At 0.02 mg/L, BCFs of 258-492 were determined.
At 0.1 mg/L, BCFs of 53-464 were determined. At 1 mg/L, BCFs of 17-195 were determined. These results indicate that the test material did not bioaccumulate in Cyprinus carpio.
Key value for chemical safety assessment
- BCF (aquatic species):
- 492 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.
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.
