4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species: fish

Data waiving:

other justification

Justification for data waiving:

other:

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

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

Adequacy of study:

supporting study

Study period:

1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment; however most probably relevant results due to high standards for testing applied by MITI, Japan.

Justification for type of information:

see Rationale and Justification for the Analogue Read-Across Approach used for the Registration of Pigment Orange 13, 34 and Pigment Red 38 (Chapter 13)

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)

Version / remarks:

12 May 1981

GLP compliance:

no

Radiolabelling:

no

Vehicle:

yes

Test organisms (species):

Cyprinus carpio

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

6 wk

Nominal and measured concentrations:

0.15 mg/L and 0.015 mg/L nominal concentration;
Concentrations were measured twice a week, however measured concentrations not reported.

Details on estimation of bioconcentration:

Calculation of BCF was performed as outlined in the guidance:
BCFn = (Concentration in exposed fish body after n weeks of exposure minus arithmetic mean concentration in control fish body at the start and after n weeks of exposure) divided by the arithmetic mean concentration in water.

Type:

BCF

Value:

> 0.75 - <= 5.6 dimensionless

Basis:

whole body w.w.

Calculation basis:

steady state

Remarks on result:

other: steady state probably reached

Remarks:

Conc.in environment / dose:0.15 mg/L

Type:

BCF

Value:

< 2.8 dimensionless

Basis:

whole body w.w.

Calculation basis:

steady state

Remarks on result:

other: steady state probably reached

Remarks:

Conc.in environment / dose:0.015

Details on results:

Applied experimental conditions are very well documented in the publication by MITI, Japan, and according to OECD 305C (1981), however apart from the final results for BCF no measured values for experimental parameters such as measured concentrations in water and fish are given (reliability category 4). According to the kinetic model developed by Arnot & Gobas (2006) together with the equation given by OECD 305 (1996, equation 5 of Annex 4) the time to reach 80 percent of steady-state (T80) can be approximated using input parameters log Kow (1.17, see section 4), test temperature (25 deg C), lipid concentration in test fish (6%) and weight of test organism (30 g). With an assumed metabolic transformation rate of zero (no transformation, worst case) T80 can be approximated to be below 1 hour. As such, 6 weeks duration for uptake phase as of the experiment is most probably sufficient to reach steady state, an important prerequisite for the method to yield reliable results.

Arnot, J.A.; Gobas, F.A.P.C. (2006) A review of bioconcentration factor (BCF) and bioaccumulation factor (BAF) assessments for organic chemicals in aquatic organisms Environmental Reviews, 14, 257-297

Validity criteria fulfilled:

not specified

Conclusions:

In a 6 weeks bioconcentration test in Carp (Cyprinus carpio) applying flow through conditions according to OECD 305C at the two exposure concentrations the following values for the bioconcentration factor were determined (steady state method):
Exposure concentration 0.15 mg/L: BCF 5.6 (w.w.)
Exposure concentration 0.015 mg/L: BCF <2.8 (w.w.)

Executive summary:

In a 6 weeks bioconcentration test in Carp (Cyprinus carpio) applying flow through conditions according to OECD 305C at the two exposure concentrations the following values for the bioconcentration factor were determined (steady state method):

Exposure concentration 0.15 mg/L: BCF 5.6 (w.w.)

Exposure concentration 0.015 mg/L: BCF <2.8 (w.w.)

Applied experimental conditions are very well documented in the publication by MITI, Japan, and according to OECD 305C (1981), however apart from the final results for BCF no measured values for experimental parameters such as measured concentrations in water and fish are given (reliability category 4). According to the kinetic model developed by Arnot & Gobas (2006) together with the equation given by OECD 305 (1996, equation 5 of Annex 4) the time to reach 80 percent of steady-state (T80) can be approximated using input parameters log Kow (1.17, see section 4), test temperature (25 deg C), lipid concentration in test fish (6%) and weight of test organism (30 g). With an assumed metabolic transformation rate of zero (no transformation, worst case) T80 can be approximated to be below 1 hour. As such, 6 weeks duration for uptake phase as of the experiment is most probably sufficient to reach steady state, an important prerequisite for the method to yield reliable results.

Arnot, J.A.; Gobas, F.A.P.C. (2006) A review of bioconcentration factor (BCF) and bioaccumulation factor (BAF) assessments for organic chemicals in aquatic organisms Environmental Reviews, 14, 257-297

Description of key information

The registration substance is practically insoluble and has a negligible vapour pressure. Due to an n-octanol/water partitioning coefficient below the trigger value of 4.5, a low biodegradation potential can be expected. As an insoluble solid the potential to cross biological membranes is negligible.

This is supported by a 6 weeks bioconcentration test in Carp (Cyprinus carpio) performed with Pigment Orange 13 according to OECD 305C. At the two exposure concentrations the following values for the bioconcentration factor were determined (steady state method):
Exposure concentration 0.15 mg/L: BCF 5.6 (w.w.)
Exposure concentration 0.015 mg/L: BCF <2.8 (w.w.)