Sodium 2-biphenylate

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

Only three test substance concentrations were tested. According to OECD Guideline 211, normally there should be at least five test concentrations arranged in a geometric series with a separation factor preferably not exceeding 3.2.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0.01, 0.03, 0.1 mg a.i./L at day 0, 7, and 16 in new media; at day 2, 9, 19 in old media

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution was prepared to give the desired series of test concentrations. 10 mg of the test susbstance were added to 1 L of dilution water and treated for 1 h with and ultrasonic bath and afterwards stirred for 24 h. Finally undissolved particles of the test substance were removed by filtration.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Bundesgesundheitsamt, Berlin, Germany; maintained since more than 15 years in the test facility
- Age of parental stock: ≤ 24 h
- Food type: Scenedesmus subspicatus
- Amount and frequency: day 1-7: 0.1 mg C/Daphnia/day; day 8-21: 0.2 mg C/Daphnia/day

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

257 - 280.2 mg/L as CaCO3

Test temperature:

25 ± 1 °C

pH:

8.0 ± 0.2

Dissolved oxygen:

Control: 8.5 - 9.2 mg/L
Highest test concentration: 8.4 - 9.2 mg/L

Nominal and measured concentrations:

Nominal test cocnentrations: control, 0.01, 0.03, 0.1 mg a.i./L
Mean measured concentrations: -, 0.009, 0.022, 0.07 mg a.i./L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, nominal volume, fill volume: glass beakers, 150 ml, 100 ml
- Aeration: none
- Renewal rate of test solution (frequency): three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstitued water (M4-medium)
- Intervals of water quality measurement: Dissolved oxygen concentration, water temperature and pH-value were measured once a week in old and fresh media, in one replicate of the control and highest test substance concentration.

OTHER TEST CONDITIONS
- Photoperiod: 16:8 h light-darkness cycle
- Light intensity: not exceeding 800 lux

EFFECT PARAMETERS MEASURED: Number of living offspring per parent animal and behaviour/mortality rate of parent Daphnia three times a week

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

0.022 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.009 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.006 other: mg a.i./L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Details on results:

- Mortality of parent animals: none
- Time to first brood release: 5 days
- Mean reproduction rates: 88.4%, 84.3% and 81.5% for the 0.01, 0.03 and 0.1 mg/L concentrations, respectively

For the assessment the NOEC was recalculated based on the geometric mean of the measured concentrations. The geometric mean measured concentrations were: 0.006, 0.011 and 0.0024 mg a.i./L.

Reference 2

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:

Please refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

0.022 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.009 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.006 other: mg a.i./L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Description of key information

NOEC (21 d): 0.006 mg a.i./L (measured, geom. mean); read across

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.006 mg/L

Additional information

Data on the chronic toxicity of sodium 2-biphenylate (CAS 132-27-4) to aquatic invertebrates are not available. The assessment was therefore based on a study conducted with the analogue substance 2-phenylphenol (CAS 90-43-7) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Further justification is given within the overall summary chapter 6.1 and within the analogue justification in IUCLID section 13.

The chronic toxicity of substance 2-phenylphenol (CAS 90-43-7) was investigated in a guideline study performed according to OEC 211 and in GLP compliance (Bruns, 2001).Daphnia magna was exposed to the substance for 21 days under semi-static exposure conditions. The tested nominal concentrations were 0.01, 0.03, and 0.1 mg a.i./L. Analytical dose verification was performed with fresh and for aged medium respectively. The fresh medium was sampled on day 0, 7, and 16, whereas the old medium was sampled at day 2, 9, and 19. Based on the arithmetic mean the analytically verified concentrations were 0.009, 0.022, 0.07 mg a.i./L. For the assessment the NOEC was recalculated based on the geometric mean of the measured concentrations. The geometric mean measured concentrations were: 0.006, 0.011 and 0.0024 mg a.i./L. Based geometric mean measured concentrations the NOEC_reproduction(21 d)was 0.006 mg a.i./L.