Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary literature
Qualifier:
according to
Guideline:
other: OECD Test Guideline 202
Principles of method if other than guideline:
Study was conducted to investigate the effects of test chemical on the mortality and reproductive rate of aquatic invertebrate daphnia magna by providing the exposure period of 21 days.
GLP compliance:
not specified
Specific details on test material used for the study:
Details on test material- Name of test material (as cited in study report): 2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-, calcium salt- Molecular formula (if other than submission substance): C18H14N2O6S.Ca- Molecular weight (if other than submission substance): 424.445 g/mole- Smiles notation (if other than submission substance): c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- InChl (if other than submission substance): 1S/C18H14N2O6S.Ca/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3, (H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Substance type: Organic - Physical state: Solid - Analytical purity: 87 %- Impurities (identity and concentrations): 13 %
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): DMSO and HCO-40 were used- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 9:1 (100 mg/kg)
Test organisms (species):
Daphnia magna
Details on test organisms:
Details on test organismsTEST ORGANISM- Common name: Water flea
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
21 d
Post exposure observation period:
24, 48, 96 hrs, 7 days, 14 days and 21 days
Nominal and measured concentrations:
5 nominal concentrations ranges from 3-300 mg/l
Details on test conditions:
Details on test conditionsTEST SYSTEM- Type (delete if not applicable): open - No. of organisms per vessel: 10 organisms per replicate were used- No. of vessels per concentration (replicates): 4- No. of vessels per control (replicates): 4- No. of vessels per vehicle control (replicates): 4
Reference substance (positive control):
not specified
Key result
Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
9.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95 % CI was 7.7-12 mg/l
Key result
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
9.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Other details not known

Fig: LC50 of test chemical on daphnia magna

Duration of exposure

LC50 / EC50 (In mg/l)

95 % CI interval (In mg/l)

Basis of effect

24 hrs

210

160-300

Mortality

48 hrs

43

31-58

Mortality

96 hrs

18

14-24

Mortality

7 days

13

10-17

Mortality

14 days

10

7.8-13

Mortality

21 days

9.7

7.7-12

Mortality

14 days

4.4

3.1-5.8

Reproduction

21 days

9.1

-

Reproduction

NOEC

3

-

Reproduction

LOEC

9.4

-

Reproduction

 -: Not specified

NOEC = 3.0 mg/l (p < 0.05)

LOEC = 9.4 mg/l (p < 0.05) Based on the reproductive effects

Validity criteria fulfilled:
not specified
Conclusions:
Based on the mortality rate of daphnia magna by the test chemical for 21 days, the LC50 was determine to be 9.7 mg/l and on the basis of reproductive rate EC50 was determine to be 9.1 mg/l.
Executive summary:

Study was conducted to investigate the effects of test chemical on the growth of aquatic invertebrates by providing the exposure period of 21 days. Study was conducted according to the OECD Test Guideline 202 in a semi-static system. SolventDMSO and HCO-40 in the ratio of 9:1 were used.5 nominal concentrations ranges from 3-300 mg/l prepared and 4 replicates were used in which 10 organisms per replicate added. After the exposure of 21 days effect on the mortality and reproduction of daphnia magna were recorded. Based on the mortality rate of daphnia magna by the test chemical for 21 days, the LC50 was determine to be 9.7 mg/l and on the basis of reproductive rate EC50 was determine to be 9.1 mg/l. Based on the long term toxicity effect, the chemical was consider as nontoxic and not classified as per the CLP classification criteria.

Description of key information

Study was conducted to investigate the effects of test chemical on the growth of aquatic invertebrates by providing the exposure period of 21 days. Study was conducted according to the OECD Test Guideline 202 in a semi-static system. SolventDMSO and HCO-40 in the ratio of 9:1 were used.5 nominal concentrations ranges from 3-300 mg/l prepared and 4 replicates were used in which 10 organisms per replicate added. After the exposure of 21 days effect on the mortality and reproduction of daphnia magna were recorded. Based on the mortality rate of daphnia magna by the test chemical for 21 days, the LC50 was determine to be 9.7 mg/l and on the basis of reproductive rate EC50 was determine to be 9.1 mg/l. Based on the long term toxicity effect, the chemical was consider as nontoxic and not classified as per the CLP classification criteria.

Key value for chemical safety assessment

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

Additional information

The Key study from secondary sources 2017 was conducted to investigate the effects of test chemical on the growth of aquatic invertebrates by providing the exposure period of 21 days. Study was conducted according to the OECD Test Guideline 202 in a semi-static system. SolventDMSO and HCO-40 in the ratio of 9:1 were used.5 nominal concentrations ranges from 3-300 mg/l prepared and 4 replicates were used in which 10 organisms per replicate added. After the exposure of 21 days effect on the mortality and reproduction of daphnia magna were recorded. Based on the mortality rate of daphnia magna by the test chemical for 21 days, the LC50 was determine to be 9.7 mg/l and on the basis of reproductive rate EC50 was determine to be 9.1 mg/l. Based on the long term toxicity effect, the chemical was consider as nontoxic and not classified as per the CLP classification criteria.