Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Long-term toxicity to aquatic invertebrates

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

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

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

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.