4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Chemical Substances Control Law (Japanese Law No.117, 1973).

Deviations:

no

GLP compliance:

yes

Radiolabelling:

no

Details on sampling:

Concentrations of the test substance in water and in whole fish body were measured periodically.

Vehicle:

yes

Remarks:

2-Methoxyethanol solution of HC0-30 (disperse medium)

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

PREPARATION OF TEST SOLUTIONS

1) Exposure Level:
Four hundred milligrams of the test substance were dissolved and diluted to 20 mL with the 2-Methoxyethanol solution of HC0-30 (disperse medium) (test substance conc.: 20 mg/mL, HC0-30 conc.: 400 mg/mL). Two point five, five, and ten milliliters of this solution were dropped with stirring in dechlorinated water (Yokohama municipal tap water was treated with activated charcoal and then aerated) and diluted to 2 L to make test concentrations of
25, 50, 100/Lg/mL. The concentration of HC0-30 ranged from 500 to 2000 µg/mL.

2) Control Level:
The 2-Methoxyethanol solution of HC0-30 (HC0-30 conc.: 400 mg/mL), 10 mL, was diluted to 2 L with dechlorinated water. The final concentration of HC0-30 was 2000 µg/mL.

Test organisms (species):

Oryzias latipes

Details on test organisms:

1) Test fish
- Species: Orange killifish (Oryzias latipes)
- Source: Niikura Fishing (1217 Simotani, Isehara, Kanagawa)
- Date of purchase: July 22, 1996
- Lot No.: 96-H-0722
- Body length: approx. 2 cm
- Body weight: approx. 0.2 g

2) Acclimation:
- Water temperature: 25±2°C
- Period: over 1 week
- Feeding: Feed (Tetramin, Tetra Werke, Germany) of approx. 2% of the body weight was given to fish once a day except holidays and for 48 hours before testing

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

10 wk

Hardness:

not indicated

Test temperature:

23.8 - 24.6°C (measured value)

pH:

not measured

Dissolved oxygen:

6.6- 7.1 ppm (measured value)

TOC:

no data

Salinity:

freshwater used

Details on test conditions:

- Test vessel: 85 l glass aquarium with 80 l water
- Type: open
- Aeration: continuous
- Type of flow-through (e.g. peristaltic or proportional diluter): Continuous flow-through diluter system (800 L/day); the turnover rate for each aquaria was 10 times per day.
- Renewal rate of test water: none
- No. of organisms per vessel: 18 fish each for low and high exposure level / 12 fish for control
- Flow rate of dilution water 800 L/day
- Flow rate of feed solution 20 mL/day

Nominal and measured concentrations:

Nominal concentrations of the test substance in water :
- High exposure level 0.2 µg/mL (HC0-30 conc. 4 µg/mL)
- Low exposure level 0.02 µg/mL (HC0-30 conc. 0.4 µg/mL)
- Control 0 µg/mL (HC0-30 conc. 4 µg/mL)

Reference substance (positive control):

no

Key result

Conc. / dose:

ca. 0.19 µg/L

Temp.:

ca. 24 °C

Type:

BCF

Value:

1 668 - 6 370 dimensionless

Basis:

not specified

Time of plateau:

6 wk

Calculation basis:

kinetic

Key result

Conc. / dose:

ca. 0.019 µg/L

Temp.:

ca. 24 °C

Type:

BCF

Value:

2 989 - 14 908 dimensionless

Basis:

not specified

Time of plateau:

10 wk

Calculation basis:

kinetic

Remarks on result:

other: equilibrium not reached after 10 weeks

Metabolites:

not measured

Results with reference substance (positive control):

no positive control tested

Details on results:

At high exposure level, the bioeoncentration factor of the test substance was determined to be 1668 - 6370 and reached to equilibrium after 6 weeks. Atlow exposure level, it was determind to be 2989 - 14908 and was not reached to
equilibrium in 10 weeks. As bioconcentration factor of the test substance at low exposure level resulted about 15000 and not reached to equilibrium, the study was stopped.

Validity criteria fulfilled:

no

Conclusions:

At high exposure level, the bioeoncentration factor of the test substance was determined to be 1668 - 6370 and reached to equilibrium after 6 weeks. Atlow exposure level, it was determind to be 2989 - 14908 and was not reached to
equilibrium in 10 weeks. As bioconcentration factor of the test substance at low exposure level resulted about 15000 and not reached to equilibrium, the study was stopped.

Executive summary:

This study was conducted to evaluate the bioconcentration potential of the test substance for notification under the Chemical Substances Control Law, Japan, following the Japanese testing methods and OECD 305C: Orange killifish was the species used. At high exposure level (0.19 µg/mL), the bioconcentration factor of the test substance was determined to be 1668 - 6370 and reached to equilibrium after 6 weeks. At low exposure level (0.019 µg/mL), BCF was determined to be 2989 - 14908 and was not reached to equilibrium in 10 weeks. Therefore, the study was stopped. A complete test at low exposure level was technically not possible.

Description of key information

Bioaccumulation in fish (stopped):

This study was conducted to evaluate the bioconcentration potential of the test substance for notification under the Chemical Substances Control Law, Japan, following the Japanese testing methods and OECD 305C: Orange killifish was the species used. At high exposure level (0.19 µg/mL), the bioconcentration factor of the test substance was determined to be 1668 - 6370 and reached to equilibrium after 6 weeks. At low exposure level (0.019 µg/mL), BCF was determined to be 2989 - 14908 and was not reached to equilibrium in 10 weeks. Therefore, the study was stopped. A complete test at low exposure levels was technically not possible.

However, based on the intended uses of the test item, direct and indirect exposure of the aquatic compartment is very unlikely.

Additional information

Source: GLP-report & expert assessment