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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in accorance to OECD Guideline No. 211 and in compliance with GLP
Reason / purpose:
reference to same study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
no data
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
Stock solution was prepared by diluting test chemical in dimethylformamide (200,000 mg/L). Test solutions were prepared by adding the corresponding amounts of stock solution into 1,000 mL of OECD medium. The concentration of solvent was 100 µL/L.
OECD M4 medium was applied.
Test concentrations were measured 3 times during 21 days before and after renewal of test solutions
Test organisms (species):
Daphnia magna
Details on test organisms:
Age: Juveniles within 24 hrs old
Supplier: Independent Administrative Institution National Institute of Environmental Studies, Japan
Daphnids were fed Chlorella vulgaris for 0.15 mg C /day/animal during the test periods.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
no
Hardness:
250 mg/L as CaCO3
Test temperature:
20 ± 1 °C
pH:
7.5 ~ 8.8
Dissolved oxygen:
7.3 ~ 8.6 mg/L (over 60 % of the air saturation value)
Nominal and measured concentrations:
Nominal
Con.
(mg/L) Measured Con. (mg/L) TWM** (mg/L) % of Nominal
0 day (new) 1 day (old) 7 day (new) 8 day (old) 14 day (new) 15 day (old)
mg/L (%*) mg/L (%*) mg/L (%*) mg/L (%*) mg/L (%*)
Control <0.002 (–) <0.002 (–) <0.002 (–) <0.002 (–) <0.002 (–) <0.002 (–) – –
Solvent Control <0.002 (–) <0.002 (–) <0.002 (–) <0.002 (–) <0.002 (–) <0.002 (–) – –
0.400 0.370 (93) 0.155 (39) 0.335 (84) 0.143 (36) 0.327 (82) 0.129 (32) 0.229 57
0.850 0.779 (92) 0.332 (39) 0.706 (83) 0.298 (35) 0.760 (89) 0.288 (34) 0.495 58
1.80 1.59 (88) 0.684 (38) 1.68 (93) 0.633 (35) 1.60 (89) 0.674 (37) 1.07 59
3.80 3.32 (87) 1.33 (35) 3.28 (86) 1.32 (35) 3.09 (81) 1.29 (34) 2.13 56
8.00 7.05 (88) 2.74 (34) 6.94 (87) 2.69 (34) 6.53 (82) 2.72 (34) 4.47 56
Details on test conditions:
Light: 800 Lux, Light periodicity: 16/8 (light/dark)
Reference substance (positive control):
not specified
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
2.48 mg/L
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
2.13 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
2.13 mg/L
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
4.47 mg/L
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
21day-EC50 (95 % confidence limits) of OBSH to Daphnia magna was 2.48 mg/L (2.31 ~ 3.63 mg/L). At the end of the test, the mortality of the parent daphnids was 0 % and 10 % in the control and solvent control, respectively. The mean number of live offspring produced per parent animal surviving at the end of the test was 92 animals and 107 animals in control and solvent control, respectively.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
The LC50 value and the 95 % confidence limits were calculated by Probit Analysis or Binominal or Moving average method. The EC50 value and the 95 % confidence limits were calculated by Logistic regression analysis method. The NOEC and the LOEC value were analysed by Bartlett test and 1-way ANOVA or Kruskal-Wallis test.

21day-EC50(95 % confidence limits) of OBSH to Daphnia magna was 2.48 mg/L (2.31~3.63mg/L). At the end of the test, the mortality of the parent daphnids was 0 % and 10 % in the control and solvent control, respectively. The mean number of live offspring produced per parent animal surviving at the end of the test was 92 animals and 107 animals in control and solvent control, respectively.

Validity criteria fulfilled:
not specified
Conclusions:
EC50 (21 d) = 2.48 mg/L
NOEC = 2.13 mg/L
Executive summary:

The chronich toxicity of OBSH towards Daphnia magna was assessed applying the OECD Guidline No. 211.

The following concentrations were tested: Control, Solvent control,0.400, 0.850, 1.80, 3.80 and 8.00 mg/L

Based on the results a 21day-EC50(95 % confidence limits) of OBSH to Daphnia magna was determined to be 2.48 mg/L (2.31~3.63 mg/L) the 21day NOEC was 2.13 mg/L. At the end of the test, the mortality of the parent daphnids was 0 % and 10 % in the control and solvent control, respectively. The mean number of live offspring produced per parent animal surviving at the end of the test was 92 animals and 107 animals in control and solvent control, respectively.

Endpoint:
long-term toxicity to aquatic invertebrates
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 daphnia 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:
21 d
Dose descriptor:
NOEC
Effect conc.:
2.13 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Conclusions:
Based on read-across to OBSH (80-51-3), the 21 -d NOEC(daphnia, 48hrs) is derived at 2.13 mg/L
Executive summary:

Based on read-across to OBSH (80-51-3), the 21 -d NOEC(daphnia, 48hrs) is derived at 2.13 mg/L

Description of key information

 Based on read-across to OBSH (80-51-3), the 21 -d NOEC(daphnia, 48hrs) is derived at 2.13 mg/L. A 21 -d reproduction study on Dapnhia magna for OBSH showed an NOEC of 2.13 mg/L (GOECD 211). Therefore, the 21-d NOEC(Daphnia) for target substance is derived at 2.13 mg/L

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
2.13 mg/L

Additional information

Based on read-across to OBSH (80-51-3), the 21 -d NOEC(daphnia, 48hrs) is derived at 2.13 mg/L. A 21 -d reproduction study on Dapnhia magna for OBSH showed an NOEC of 2.13 mg/L (GOECD 211). Therefore, the 21-d NOEC(Daphnia) for target substance is derived at 2.13 mg/L