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Long-term toxicity to fish

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Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016.08.25-2016.11.11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study (OECD 210) according to GLP
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Version / remarks:
July 26, 2013
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
CAS No. 80-51-3
EC No. 201-286-1
KIT Code No. K-5450
Batch/Lot No. 201512001
Appearance: White fine powder
Purity: 99.5-100 %
Expiry date: December, 2016
Storage conditions: Room temperature/ Protect from moisture and light
Analytical monitoring:
yes
Details on sampling:
The concentrations of 4,4’-Oxybis(benzenesulfonyl hydrazide) (OBSH) in the test solution were verified using a HPLC method (see Analytical Report).
An analysis of the test solution was performed in the controls and each exposure concentration on before starting test, at the start, and on day 3, 10, 17, 24, 31, 38 and 45 (at the end) during the study.
A portion (5 mL) of the test solution was taken from each replicate (control and all test concentrations) on 1 day before starting the test, on the day of egg addition (Day 0), Day 3, 10, 17, 24, 31, 38 and 45. All samples were treated according to the recovery test before analysis.
Vehicle:
yes
Details on test solutions:
Dimethylforamide (DMF) was applied as a solvent
Test organisms (species):
Oryzias latipes
Details on test organisms:
Ricefish (Oryzias latipes)
Source: Fish culture room, Environmental Toxicology and Chemistry Research Center, Gyeongnam Department of Environmental Toxicology and Chemistry, Korea Institute of Toxicology (KIT)
Fertilized eggs, approximately 1-hour-old (1-2 cells stage) at the start of the study.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
45 d
Remarks on exposure duration:
Experimental Starting Date August 25, 2016 Experimental Completion Date: November 11, 2016
Post exposure observation period:
not included
Hardness:
Day 0: Control mean value 33 mg/L (31-35)
Day 45: Control mean value 37.5 mg/L (37-38)
Test temperature:
ranging from 24.0-25.1 C
pH:
ranging from 7.25-7.88
Dissolved oxygen:
ranging from 7.51-8.80 mg/L (91-105% of Air Saturation Value),
Salinity:
NA
Conductivity:
NA
Nominal and measured concentrations:
Nominal: control, solvent control, 0.1; 0.31; 0.98; 3.13; 10 mg/L
meassured concentration: ND; ND; 0.09; 0.30; 1,01; 3.28; 10;22 mg/L
Details on test conditions:
The definitive test employed five test concentrations, together with a dilution water control and solvent control (100 µL DMF/L)
The concentrations were control, solvent control and nominal concentrations of 0.1, 0.31, 0.98, 3.13, 10 mg/L (factor: 3.2 from highest concentration) based on preliminary acute toxicity test as range-finding test.
The test vessel was Teflon aquaria, with approximate dimensions of 16.0 × 7.0 × 9.0 cm (length, width, height) fitted with a surface overflow (7.0 cm above the base), to hold an approximate volume of 800 mL of exposure medium. At the start of study, each test vessel contained one egg container (4 cm diameter), fitted with mesh ends to permit flow of the test solution in the vessel.
Twenty fertilized eggs were placed into each egg container, giving a total of 80 eggs per treatment group. Developing embryos were exposed under continuous flow conditions to the test or control media for a period of 45 days (approximately 15 days pre-hatch plus 30 days post-hatch). The egg containers were removed from the test vessels, when all of the eggs had hatched.
Reference substance (positive control):
not specified
Key result
Duration:
45 d
Dose descriptor:
EC50
Remarks:
hatching rate success
Effect conc.:
4.36 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
4.36 mg/L (1.44-25.9)
Key result
Duration:
45 d
Dose descriptor:
LOEC
Remarks:
Hatching rate succes
Effect conc.:
3.28 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Key result
Duration:
45 d
Dose descriptor:
NOEC
Remarks:
Hatching rate success
Effect conc.:
1.01 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Key result
Duration:
45 d
Dose descriptor:
LC50
Remarks:
post hatch survival
Effect conc.:
0.65 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
0.65 mg/L (0.45-0.89)
Basis for effect:
mortality
Key result
Duration:
45 d
Dose descriptor:
LOEC
Remarks:
Post hatch survival
Effect conc.:
0.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
45 d
Dose descriptor:
NOEC
Remarks:
Post hatch survival
Effect conc.:
0.09 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
45 d
Dose descriptor:
LC50
Remarks:
Overall survival
Effect conc.:
0.42 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
0.42 mg/L (0.28-0.57)
Basis for effect:
mortality
Key result
Duration:
45 d
Dose descriptor:
LOEC
Remarks:
Overall survival
Effect conc.:
0.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
45 d
Dose descriptor:
NOEC
Remarks:
Overall survival
Effect conc.:
0.09 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The arithmetic mean was used to calculate overall concentration during test period because all measured concentration within 80-120% of nominal concentration. The arithmetic mean measured concentrations were 0.09, 0.30, 1.01, 3.28 and 10.22 mg/L for 0.1, 0.31, 0.98, 3.13, 10 mg/L of nominal concentration during test period.

Results with reference substance (positive control):
No data
Reported statistics and error estimates:
The data of hatching rate (hatching success) and normal survival (post hatching survival), normality (overall survival), length and weight at the end of the study were subjected to statistical analysis.
The toxicity value (LCX or ECX or ICX), LOEC and NOEC for each response was analyzed using CETIS Version 1.8.7. 15 (Tidepool Scientific Software, USA) by comparisons of each treatment group to the solvent control group.

In the present study, the solvent control was used for all subsequent comparisons because there were no significant differences between dilution water control and solvent control (by Equal Variance t Two-sample Test and Wilcoxon Rank Sum Two-Sample Test). A parametric test was used to determine if data were normally distributed and whether variances were homogeneous across treatments. If these assumptions were violated, non-parametric tests were used to determine the LOEC and NOEC.
The toxicity effects (ECX or LCX or ICX with 95% confidence limits) of each response of treatment groups compared to the solvent control group were analyzed by Linear regression and linear Interpolation method. The LOEC and NOEC were analyzed by Dunnett Multiple Comparison Test

Validity criteria fulfilled:
yes
Conclusions:
4,4’-Oxybis(benzenesulfonyl hydrazide) (OBSH) had effects on the hatching success depending on expose concentrations.

(95% confidence limit) LC/EC/IC50 LOEC NOEC
Hatching success rate 4.36 (1.44-25.9) 3.28 1.01
Post-hatching survival 0.65 (0.45-0.89) 0.30 0.09
Overall survival 0.42 (0.28-0.57) 0.30 0.09
Executive summary:

A 45 days laboratory study was conducted with the test substance 4,4’-Oxybis(benzenesulfonyl hydrazide) (OBSH), applying OECD guideline no 210 and following GLP. The results showed that the test substance had effects on the hatching success depending on the exposure concentrations.

      

Hatching success (rate) ranged from 41.3 to 86.3% in the exposure groups compared to 90.0 and 92.5% for the control and solvent control groups. Up to 11 days,  more than 80% of embryos survived at any concentration employed in the test (0.1 to 10 mg/L), however from 12 days, number of dead embryos (absence of heart-beat or body movement) increased depending on concentrations. Finally, the survival rate of embryos was 90, 92.5, 86.3, 72.5, 63.8, 43.8 and 41.8% for control, solvent control, 0.09, 0.30, 1.01, 3.28 and 10.22 mg/L (mean measured concentrations), respectively.

 

LC/EC/IC50 (95% confidence limit)

LOEC

NOEC

Hatching success rate

4.36 (1.44-25.9)

3.28

1.01

Post-hatching survival

0.65 (0.45-0.89)

0.30

0.09

Overall survival

0.42 (0.28-0.57)

0.30

0.09

Endpoint:
fish early-life stage toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Read-across from long-term toxicity study in fish on one closely structural and physicochemical related substance: OBSH (4,4'-Oxybis (benzenesulfonyl hydrazide)).
For further read-across justification se document attached in section 13.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Duration:
45 d
Dose descriptor:
NOEC
Effect conc.:
0.09 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
time to hatch
Conclusions:
Based on a read-across to OBSH, the long-term NOEC(Oryzias latipes, 45d) is derived at 0.09 mg/L
Executive summary:

Based on a read-across to OBSH, the long-term NOEC(Oryzias latipes, 45d) is derived at 0.09 mg/L

Description of key information

Based on a read-across to OBSH, the long-term NOEC(Oryzias latipes, 45d) is derived at 0.09 mg/L

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
0.09 mg/L

Additional information