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EC number: 205-593-1 | CAS number: 143-23-7
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “read-across: supporting information”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- assessment report
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 5 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- act. ingr.
- Remarks:
- BHT
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL: 4.2-6.3 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.54 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL 0.35-0.74 mg BHT/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a reliable freshwater algae growth inhibition test performed compliant to GLP and according to OECD 201 and EU-method C.3 (RL category 1) the following (no)effect concentrations were determined for the test item BHT amine based on time weighted mean measured concentrations of the active ingredient BHT:
EC50 (72 h, GR): 9.3 mg test item/L (5 mg BHT/L), 95% CL 7.9-12 mg BHT amine/L (4.2-6.3 mg BHT/L)
EC10 (72 h, GR): 1.0 mg test item/L (0.54 mg BHT/L), 95% CL 0.65-1.38 mg BHT amine/L (0.35-0.74 mg BHT/L)
NOEC (72 h, GR&Y): 0.010 mg test item/L (0.0053 mg BHT/L)
LOEC (72 h, GR&Y): 0.13 mg test item/L (0.070 mg BHT/L) - Executive summary:
The impact of the test item BHT amine on the growth of the freshwater green algal species Pseudokirchneriella subcapitata was investigated in a 72 hour static test according to the OECD Guideline 201 (2006) and the Commission Regulation (EC) No 761/2009, C.3.
The nominal concentrations of the test item of 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L (corresponding to 0.017, 0.054, 0.17, 0.54, 1.7, 5.4 mg BHT/L and to 0.0059, 0.019, 0.059, 0.19, 0.59, 1.9 mg HMD/L, respectively) were tested in parallel with a control.
The measured concentrations of the active ingredient BHT of the test item BHT amine in the test media of the test concentrations of 0.1 to 10 mg/L were between 75 and 108% of the nominal values at the start of the test. During the test period of 24 and 72 hours, a decrease of test item concentration in the test media occurred. After 24 hours and at the end of the test, 4 to 89% and 2 to 93% of the nominal values were found, respectively. The losses were considered to be due to adsorption of the test item onto the algae and the test vessels, particularly in the low-level samples.
The other active ingredient HMD was analyzed in the test and proved to be essentially stable under test conditions. In a supporting study HMD proved to be of very low toxicity to Pseudokirchneriella subcapitata (LC50 72h, GR: > 100 mg/L). Therefore as a conservative approach the evaluation was based on time weighted mean measured concentrations of the active ingredient BHT. Time weighing was applied to account for the different intervals between the analytically measured time points 24 and 72 hours (0 – 24 h and 24 – 72 h).
The following (no)effect concentrations were determined for the test item BHT amine based on time wheighted mean measured concentrations of the active ingredient BHT:
EC50 (72 h, GR): 9.3 mg test item/L (5 mg BHT/L), 95% CL 7.9-12 mg BHT amine/L (4.2-6.3 mg BHT/L)
EC10 (72 h, GR): 1.0 mg test item/L (0.54 mg BHT/L), 95% CL 0.65-1.38 mg BHT amine/L (0.35-0.74 mg BHT/L)
NOEC (72 h, GR&Y): 0.010 mg test item/L (0.0053 mg BHT/L)
LOEC (72 h, GR&Y): 0.13 mg test item/L (0.070 mg BHT/L).
The study used as source investigated Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine (EC 907 -605 -7, which contains relevant amounts of the submission substance,
7-azatridecane-1,13-diamine).The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Reference
Description of key information
The impact of the test item BHT amine (reaction mass containing BHT as main constituent, at 53.5%) on the growth of the freshwater green algal species Pseudokirchneriella subcapitata was investigated in a 72 hour static test according to the OECD Guideline 201 (2006) and the Commission Regulation (EC) No 761/2009, C.3.
The nominal concentrations of the test item of 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L (corresponding to 0.017, 0.054, 0.17, 0.54, 1.7, 5.4 mg BHT/L and to 0.0059, 0.019, 0.059, 0.19, 0.59, 1.9 mg HMD/L, respectively) were tested in parallel with a control.
The measured concentrations of the active ingredient BHT of the test item BHT amine in the test media of the test concentrations of 0.1 to 10 mg/L were between 75 and 108% of the nominal values at the start of the test. During the test period of 24 and 72 hours, a decrease of test item concentration in the test media occurred. After 24 hours and at the end of the test, 4 to 89% and 2 to 93% of the nominal values were found, respectively. The losses were considered to be due to adsorption of the test item onto the algae and the test vessels, particularly in the low-level samples.
The other active ingredient HMD was analyzed in the test and proved to be essentially stable under test conditions. In a supporting study HMD proved to be of very low toxicity to Pseudokirchneriella subcapitata (LC50 72h, GR: > 100 mg/L). Therefore as a conservative approach the evaluation was based on time weighted mean measured concentrations of the active ingredient BHT. Time weighing was applied to account for the different intervals between the analytically measured time points 24 and 72 hours (0 – 24 h and 24 – 72 h).
The following (no)effect concentrations were determined for the test item BHT amine based on time wheighted mean measured concentrations of the active ingredient BHT:
EC50 (72 h, GR): 9.3 mg test item/L (5 mg BHT/L), 95% CL 7.9-12 mg BHT amine/L (4.2-6.3 mg BHT/L)
EC10 (72 h, GR): 1.0 mg test item/L (0.54 mg BHT/L), 95% CL 0.65-1.38 mg BHT amine/L (0.35-0.74 mg BHT/L)
NOEC (72 h, GR&Y): 0.010 mg test item/L (0.0053 mg BHT/L)
LOEC (72 h, GR&Y): 0.13 mg test item/L (0.070 mg BHT/L)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 5 mg/L
- EC10 or NOEC for freshwater algae:
- 0.54 mg/L
Additional information
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