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EC number: 207-332-7 | CAS number: 463-04-7
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- GLP compliance:
- yes (incl. QA statement)
- Test temperature:
- 23 ± 2°C
- Nominal and measured concentrations:
- Target concentrations (mg.L-1)
Control
Solvent control
0.3
0.95
3.05
9.77
31.25
100 - Details on test conditions:
- Light: continuous illumination between 4440 and 8880 lux
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.14 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.53 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.15 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.11 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- yield
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to an experimental study performed on isoamyl nitrite according to the OECD TG 201 and under GLP conditions, the 72h-EC50 (growth rate) was found to be 2.14 mg/L.
- Executive summary:
The objective of this study was to assess the effects of test item Isoamyl Nitrite on the growth of Pseudokirchneriella subcapitata over a period of 72 hours according to OECD 201 Guideline. Pseudokirchneriella subcapitata is a freshwater green algae that is recommended by the OECD Guideline 201.
Since the substance is volatile and is not soluble in under conditions of the test, the test was carried out in closed bottles and the substance was added by injection through the septum.
Test item quantification was performed according to a validated analytical method (final report RRCo-000234_01) on a GC-MS/MS from Agilent (GC 7890b and MS triple quadrupole 7000b or c) as mass spectrometry detection was found suitable to measure Isoamyl Nitrite concentrations at 0, 24, 48 and 72 hours.
The effects of Isoamyl Nitrite at the definitive nominal concentrations of 0; 0.3; 0.95; 3.05; 9.77; 31.25 and 100 mg.L-1 to Pseudokirchneriella subcapitata were investigated under laboratory conditions.
Due to the instability of test item, the calculations were performed on the nominal concentrations.
Results are the following:
Isoamyl Nitrite
ECgrowth rate 10-72h (95% confidence limits): 0.15 mg.L-1 (95% confidence limits: 0.05 – 0.30 mg.L-1)
ECgrowth rate 50-72h (95% confidence limits): 2.14 mg.L-1 (95% confidence limits: 1.59 – 3.33 mg.L-1)
ECyield 10-72h (95% confidence limits): 0.11 mg.L-1 (95% confidence limits: 0.02 – 0.22 mg.L-1)
ECyield 50-72h (95% confidence limits): 0.53 mg.L-1 (95% confidence limits: 0.31 – 0.75 mg.L-1)
The study is valid since the growth multiplication factor in the control within the 72-hour test period was higher than 16 (actual value: 17), the coefficient of variation of the average specific growth rates in the control was less than 7% (actual value: 6.89%)
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control was not reached (actual value: 67.08% after 72h, the criteria is fixed at < 35%). Indeed, the bottles being sacrificial, the daily monitoring was not on the same bottle. It is therefore not significant to follow the growth of a replicate in time because it is not the same bottle.
This is no impact on the study, the other criteria were reached, so the study is valid.
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- SOURCE AND TARGET CHEMICAL(S)
The read-across has been performed between pentyl nitrite (CAS No. 463-04-7; target chemical) and isoamyl nitrite (CAS No. 110-46-3; source chemical). The RA is based on an experimental study performed on the source substance having a purity of 98.1%, in accordance with the OECD TG 201 and under GLP conditions.
ANALOGUE APPROACH JUSTIFICATION
The source substance and the target substance have the same chemical formula (C5H11NO2) and belong to the alkyl nitrites family. Like other alkyl nitrites, chemical and biological properties are mainly due to the nitrite group. Both target and source substances have similar physico-chemical properties.
For all these reasons, it is expected that the registered substance pentyl nitrite will have a similar ecotoxicity than the source substance isoamyl nitrite. The read-across approach between both alkyl nitrite substances is therefore considered relevant for this endpoint.
The 72h-EC50 (growth rate) was found to be 2.14 mg/L for Isoamyl nitrite. The study was performed on Pseudokirchneriella subcapitata according to the OECD TG 201 under GLP conditions. This experimental study was considered valid.
It is expected that similar results would be also found if a test was performed with pentyl nitrite. Due to the absence of experimental data on pentyl nitrite, it is therefore considered relevant to extrapolate results from the study on isoamyl nitrite to the registered substance. - Reason / purpose for cross-reference:
- read-across source
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.14 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.53 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.15 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.11 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Remarks:
- yield
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on a read-across on an experimental study performed on another alkyl nitrite substance (isoamyl nitrite) in accordance with the OECD TG 201 and under GLP conditions, the key value selected for the registered substance pentyl nitrite is the following: 72h-EC50 (growth rate) = 2.14 mg/L.
- Executive summary:
For that endpoint, a read-across was performed between pentyl nitrite (CAS No. 463-04-7; target chemical) and isoamyl nitrite (CAS No. 110-46-3; source chemical).
The source substance and the target substance have the same chemical formula (C5H11NO2) and belong to the alkyl nitrites family. Like other alkyl nitrites, chemical and biological properties are mainly due to the nitrite group. Both target and source substances have similar physico-chemical properties.
For all these reasons, it is expected that the registered substance pentyl nitrite will have a similar ecotoxicity than the source substance isoamyl nitrite. The read-across approach between both alkyl nitrite substances is therefore considered relevant for this endpoint.
An experimental study performed on the source substance isoamyl nitrite was available, and was conduted according to the OECD TG 201 under GLP conditions.
The objective of this study was to assess the effects of test item Isoamyl Nitrite on the growth of Pseudokirchneriella subcapitata over a period of 72 hours according to OECD 201 Guideline. Pseudokirchneriella subcapitata is a freshwater green algae that is recommended by the OECD Guideline 201.
Since the substance is volatile and is not soluble in under conditions of the test, the test was carried out in closed bottles and the substance was added by injection through the septum.
Test item quantification was performed according to a validated analytical method (final report RRCo-000234_01) on a GC-MS/MS from Agilent (GC 7890b and MS triple quadrupole 7000b or c) as mass spectrometry detection was found suitable to measure Isoamyl Nitrite concentrations at 0, 24, 48 and 72 hours.
The effects of Isoamyl Nitrite at the definitive nominal concentrations of 0; 0.3; 0.95; 3.05; 9.77; 31.25 and 100 mg.L-1 to Pseudokirchneriella subcapitata were investigated under laboratory conditions.
Due to the instability of test item, the calculations were performed on the nominal concentrations.
Results were the following for Isoamyl Nitrite:
ECgrowth rate 10-72h (95% confidence limits): 0.15 mg.L-1 (95% confidence limits: 0.05 – 0.30 mg.L-1)
ECgrowth rate 50-72h (95% confidence limits): 2.14 mg.L-1 (95% confidence limits: 1.59 – 3.33 mg.L-1)
ECyield 10-72h (95% confidence limits): 0.11 mg.L-1 (95% confidence limits: 0.02 – 0.22 mg.L-1)
ECyield 50-72h (95% confidence limits): 0.53 mg.L-1 (95% confidence limits: 0.31 – 0.75 mg.L-1)
The study is valid since the growth multiplication factor in the control within the 72-hour test period was higher than 16 (actual value: 17), the coefficient of variation of the average specific growth rates in the control was less than 7% (actual value: 6.89%)
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control was not reached (actual value: 67.08% after 72h, the criteria is fixed at < 35%). Indeed, the bottles being sacrificial, the daily monitoring was not on the same bottle. It is therefore not significant to follow the growth of a replicate in time because it is not the same bottle.
This is no impact on the study, the other criteria were reached, so the study is considered acceptable.
It is expected that similar results would be also found if a test was performed with pentyl nitrite. Due to the absence of experimental data on pentyl nitrite, it is therefore considered relevant to extrapolate results from the study on isoamyl nitrite to the registered substance.
Referenceopen allclose all
Description of key information
Based on a read-across on an experimental study performed on another alkyl nitrite substance (isoamyl nitrite) in accordance with the OECD TG 201 and under GLP conditions, the key value selected for the registered substance pentyl nitrite is the following: 72h-EC50 (growth rate) = 2.14 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 2.14 mg/L
- EC10 or NOEC for freshwater algae:
- 0.15 mg/L
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.
