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Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
fish, juvenile growth test
Type of information:
experimental study
Remarks:
Experimental data of read across substances
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data for the target chemical is summarized based on the read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline available
Principles of method if other than guideline:
WoE report is based on two long term toxicity to fish studies as-
WoE 2 and WoE 3.
GLP compliance:
not specified
Analytical monitoring:
yes
Details on sampling:
WoE 2 - Concentrations: (nominal values) control, vehicle control, concentration 1: 0.020 mg/L, concentration 2: 0.058 mg/L, concentration 3: 0.17 mg/L, concentration 4: 0.48 mg/L, concentration 5: 1.4 mg/L (geometric ratio: 2.9)
Vehicle:
yes
Remarks:
WoE 2- N,N-Dimethylformamide, HCO-60
Details on test solutions:

WoE 2- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): N,N-Dimethylformamide, HCO-60
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): constant concentration, N,N-Dimethylformamide: ca. 100 microL/L, HCO-60: ca. 2.0 mg/L
Test organisms (species):
Oryzias latipes
Details on test organisms:
WoE 2- TEST ORGANISM
- Common name: Japanese rice fish

POST-HATCH FEEDING
- Type/source of feed: BSN* (*: brine shrimp hatching larva just after hatching) for larval and juvenile fish)
- Amount given: full feeding - Frequency of feeding: 1- 2 times per day

WoE 3- TEST ORGANISM
- Common name: Japanese rice fish
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
42 d
Remarks on exposure duration:
WoE 2- exposed from fertilized egg, until after 30 days from the day when hatching rate became more than 70 % in control

WoE 3- 28 days
Test temperature:
WoE 2- egg and embryo stages: 24 ±1 °C larval and juvenile fish stages: 23 ± 2 °C
Dissolved oxygen:
WoE 2- maintained more than 60% of the saturated concentration (not aeration)
Nominal and measured concentrations:
WoE 2- (nominal values) control, vehicle control, concentration 1: 0.020 mg/L, concentration 2: 0.058 mg/L, concentration 3: 0.17 mg/L, concentration 4: 0.48 mg/L, concentration 5: 1.4 mg/L (geometric ratio: 2.9)
Details on test conditions:
WoE 2- TEST SYSTEM
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): test solution supply volume: 48 L/vessel/day, liquid volume in test vessel: 2.5 L (renewal rate: 19 times/day)
- No. of fertilized eggs/embryos per vessel: 60/concentration (20/vessel)
- No. of vessels per concentration (replicates): 3


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light per 8 hours darkness
- Light intensity: less than 1000 lux




Reference substance (positive control):
not specified
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.154 - < 0.92 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: NOEC value of test chemical was determined to be > 0.154 to < 0.92 mg/l.
Key result
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 0.435 - < 1.92 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: LOEC value of test chemical was determined to be > 0.435 to < 1.92 mg/l.
Validity criteria fulfilled:
not specified
Conclusions:
On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 28 days NOEC value of test chemical was determined to be > 0.154 to < 0.92 mg/l and LOEC value was determined to be > 0.435 to < 1.92 mg/l.
Executive summary:

Data available of the structurally similar read across chemicals have been reviewed to determine the effect of the test chemical on fishes. The studies are as mentioned below:


 


A first study of long-term toxicity to fish was carried out according to OECD 210 guideline. Oryzias latipes (Japanese rice fish) was taken as test organism. The duration of test was 42 days, exposed from fertilized egg, until after 30 days from the day when hatching rate became more than 70 % in control. Post-hatch feeding includes BSN type of food (*: brine shrimp hatching larva just after hatching for larval and juvenile fish). Full feeding was given to test fishes, frequency of feeding was 1- 2 times per day. N,N-Dimethylformamide, HCO-60 was taken as vehicle, N,N-Dimethylformamide was taken as ca. 100 microL/L, HCO-60 was taken as ca. 2.0 mg/L. Test concentrations were taken as 0.020 mg/L,  0.058 mg/L, 0.17 mg/L, 0.48 mg/L, 1.4 mg/L in geometric ratio of 2.9. The renewal rate of the test solution was 19 times/day, 48 L/vessel/day. The liquid volume in test vessel was 2.5 L. Number of fertilized eggs/embryos per vessel was 60 per concentration, 20 per vessel. The number of vessels per concentration replicates was taken as three. Adjustment of pH was not adjusted. Photoperiod was given as 16 hours of light per 8 hours darkness. Light intensity was given as less than 1000 lux. Test temperature at egg and embryo stages was 24 ±1 °C and at  larval -juvenile fish stages was 23 ± 2 °C. Dissolved oxygen was maintained at more than 60% of the saturated concentration. Analytical monitoring was done by HPLC. On the basis of survival rate effect of test chemical on test organisms Oryzias latipes (Japanese rice fish) the 42 days NOEC and LOEC value of test chemical was determined to be 0.154 mg/l and 0.435 mg/l respectively. Based of the value of NOEC the test chemical was classified as Chronic category 2 as per CLP criteria. 


The second study of long-term toxicity to fish was carried out. Oryzias latipes (Japanese rice fish) was taken as test organism. The duration of test was 28 days. On the basis of growth effect of test chemical on test organisms Oryzias latipes (Japanese rice fish) the 28 days NOEC and LOEC value of test chemical was determined to be 0.92 mg/l and 1.92 mg/l respectively. Based of the value of NOEC the test chemical was classified as 'Chronic category 2' as per CLP criteria. 


 


On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 28 days NOEC value of test chemical was determined to be > 0.154 to < 0.92 mg/l and LOEC value was determined to be > 0.435 to < 1.92 mg/l. Based of the value of NOEC the test chemical was classified as 'Chronic category 2' as per CLP criteria. 


 

Description of key information

On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 28 days NOEC value of test chemical was determined to be > 0.154 to < 0.92 mg/l and LOEC value was determined to be > 0.435 to < 1.92 mg/l.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
NOEC
Effect concentration:
> 0.154 - < 0.92 mg/L

Additional information

Data available of the structurally similar read across chemicals have been reviewed to determine the effect of the test chemical on fishes. The studies are as mentioned below:


 


The first study of long-term toxicity to fish was carried out according to OECD 210 guideline. Oryzias latipes (Japanese rice fish) was taken as test organism. The duration of test was 42 days, exposed from fertilized egg, until after 30 days from the day when hatching rate became more than 70 % in control. Post-hatch feeding includes BSN type of food (*: brine shrimp hatching larva just after hatching for larval and juvenile fish). Full feeding was given to test fishes, frequency of feeding was 1- 2 times per day. N,N-Dimethylformamide, HCO-60 was taken as vehicle, N,N-Dimethylformamide was taken as ca. 100 microL/L, HCO-60 was taken as ca. 2.0 mg/L. Test concentrations were taken as 0.020 mg/L,  0.058 mg/L, 0.17 mg/L, 0.48 mg/L, 1.4 mg/L in geometric ratio of 2.9. The renewal rate of the test solution was 19 times/day, 48 L/vessel/day. The liquid volume in test vessel was 2.5 L. Number of fertilized eggs/embryos per vessel was 60 per concentration, 20 per vessel. The number of vessels per concentration replicates was taken as three. Adjustment of pH was not adjusted. Photoperiod was given as 16 hours of light per 8 hours darkness. Light intensity was given as less than 1000 lux. Test temperature at egg and embryo stages was 24 ±1 °C and at  larval -juvenile fish stages was 23 ± 2 °C. Dissolved oxygen was maintained at more than 60% of the saturated concentration. Analytical monitoring was done by HPLC. On the basis of survival rate effect of test chemical on test organisms Oryzias latipes (Japanese rice fish) the 42 days NOEC and LOEC value of test chemical was determined to be 0.154 mg/l and 0.435 mg/l respectively. Based of the value of NOEC the test chemical was classified as Chronic category 2 as per CLP criteria. 


The second study of long-term toxicity to fish was carried out. Oryzias latipes (Japanese rice fish) was taken as test organism. The duration of test was 28 days. On the basis of growth effect of test chemical on test organisms Oryzias latipes (Japanese rice fish) the 28 days NOEC and LOEC value of test chemical was determined to be 0.92 mg/l and 1.92 mg/l respectively. Based of the value of NOEC the test chemical was classified as 'Chronic category 2' as per CLP criteria. 


 


On the basis of the experimental studies of the structurally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 28 days NOEC value of test chemical was determined to be > 0.154 to < 0.92 mg/l and LOEC value was determined to be > 0.435 to < 1.92 mg/l. Based of the value of NOEC the test chemical was classified as 'Chronic category 2' as per CLP criteria.