Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

see read across justification in section 13

Reason / purpose for cross-reference:

read-across source

GLP compliance:

not specified

Lipid content:

4.7 %

Type:

BCF

Value:

< 11

Remarks on result:

other: calculation based on detection limit

Remarks:

Conc.in environment / dose:0.2 mg/L

Type:

BCF

Value:

< 1.1

Remarks on result:

other: calculation based on detection limit

Remarks:

Conc.in environment / dose:2 mg/L

Details on kinetic parameters:

no data

Metabolites:

no data

Results with reference substance (positive control):

no data

Details on results:

- Mortality of test organisms: no deaths
- Behavioural abnormalities: no
- Observations on body length and weight: NAD
- Other biological observations: none
- Organ specific bioaccumulation: -
- Bound residues forming a plateau: -
- Mortality and/or behavioural abnormalities of control: -
- Loss of test substance during test period: -
- Results with vehicle control: NA

Reported statistics:

NA

Validity criteria fulfilled:

yes

Conclusions:

The test substance does not bioaccumulate in aquatic test species

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 10, 1982 - March 12, 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented publication

Qualifier:

according to guideline

Guideline:

other: Kanpogyo No. 5, Yakuhatsu No. 615, 49 Kikyoku No. 392: Bioaccumulation test of the chemical substances in fish and shellfish

GLP compliance:

not specified

Radiolabelling:

no

Details on sampling:

- Sampling intervals: Weeks 2, 3, 4, 6
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
- For fish analysis
100 mL of 1 % Capriquart/benzene was added to 100 ppm methanol solution of the test substance. After drying, benzene was added to prepare the standard solution at the determined concentration.
- For water analysis
100 mL of 100 ppm Capriquart/benzene was added to 100 ppm methanol solution of the test substance. After drying, methanol was added to prepare the standard solution at the determined concentration.

Vehicle:

no

Details on preparation of test solutions, spiked fish food or sediment:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Desalted water was added to 10 g of the test substance to make the total volume of 1 L, to give a final concentration of 10,000 ppm (w/v). No correction of the purity was conducted. Tis solution was diluted to the stock solution.
- Stock solution: water for dilution = 4 mL/minute : 400 mL/minute
stock solution for the first concentration area: 200 ppm (w/v) --> 2 ppm
stock solution for the second concentration area: 20 ppm (w/v) --> 0.2 ppm
- Controls: dilution water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Reasons for establishing the concentration:
The concentration at which quantitative analysis can be conducted with high accuracy is 7.5 ppb. The recovery rate was 95.4% at 50-fold accumulation in the pretreatment procedures in the water analysis and from the result obtained by 5-day preliminary breeding reduction of the concentration in the aquarium was estimated to be 10%. Therefore the concentration in the aquarium of the second concentration area was established to be 0.2 ppm. The concentration in the first concentration area was determined to be 10-fold of those in the second concentration area.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp (Cyprinus carpio)
- Length at study initiation (mean): 10.6 cm
- Weight at study initiation (mean): 31.5 g
- Lipid content (mean): 4.7%
- Description of housing/holding area: 100 L glass aquarium
- Flow rate: 582 L/day


ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: 25°C
- External disinfection: 24-hour bathing in a 10 ppm chlortetracycline hydrochloride aqueous solution was conducted under the static water system.

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

6 wk

Hardness:

no data

Test temperature:

24°C to 26°C

pH:

no data

Dissolved oxygen:

2 ppm: 6.8 - 7.1 ppm
0.2 ppm: 6.5 - 6.8 ppm

TOC:

no data

Salinity:

NA

Details on test conditions:

Test conditions
- Apparatus for controlling the aqueous system environment: Flow through system
Test aquarium: Glass-made
Volume 100 L
Flow rate 582 L/day

Nominal and measured concentrations:

Nominal: 2.0 mg/L (ppm) -- Measured: 1.89 to 1.92 ppm
Nominal: 0.2 mg/L (ppm) -- Measured: 0.188 to 0.191 ppm

Reference substance (positive control):

not specified

Details on estimation of bioconcentration:

BASIS INFORMATION
- Measured/calculated logPow: -4.3
- Results from toxicokinetic study: 30% oral bioavailability in rats
- Results from residue study: -
- Monitoring data: -

BASIS FOR CALCULATION OF BCF
- Estimation software: EPIWEB 4.0
- Result based on measured log Pow of: -4.34
Log BCF (regression-based estimate): 0.50 (BCF = 3.16 L/kg wet-wt)
Biotransformation Half-Life (days) : 1.51e-005 (normalized to 10 g fish)
Log BAF (Arnot-Gobas upper trophic): -0.05 (BAF = 0.893 L/kg wet-wt)
- Result based on calculated log Pow of: -4.13
Log BCF (regression-based estimate): 0.50 (BCF = 3.16 L/kg wet-wt)
Biotransformation Half-Life (days) : 3.19e-006 (normalized to 10 g fish)
Log BAF (Arnot-Gobas upper trophic): -0.05 (BAF = 0.893 L/kg wet-wt)

Lipid content:

4.7 %

Type:

BCF

Value:

< 11

Remarks on result:

other: calculation based on detection limit

Remarks:

Conc.in environment / dose:0.2 mg/L

Type:

BCF

Value:

< 1.1

Remarks on result:

other: calculation based on detection limit

Remarks:

Conc.in environment / dose:2 mg/L

Details on kinetic parameters:

no data

Metabolites:

no data

Results with reference substance (positive control):

no data

Details on results:

- Mortality of test organisms: no deaths
- Behavioural abnormalities: no
- Observations on body length and weight: NAD
- Other biological observations: none
- Organ specific bioaccumulation: -
- Bound residues forming a plateau: -
- Mortality and/or behavioural abnormalities of control: -
- Loss of test substance during test period: -
- Results with vehicle control: NA

Reported statistics:

NA

Validity criteria fulfilled:

yes

Conclusions:

The test substance does not bioaccumulate in aquatic test species

Description of key information

The substance is not bioaccumulative

Key value for chemical safety assessment

BCF (aquatic species):

11 dimensionless

Additional information

Conc. in environment / dose	Type	Value	Basis	Time of plateau	Calculation basis	Remarks
0.2 mg/L	BCF	< 11				calculation based on detection limit
2 mg/L	BCF	< 1.1				calculation based on detection limit