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Environmental fate & pathways

Bioaccumulation: aquatic / sediment

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Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to a guideline study. Test procedure in accordance with generally accepted scientific standards and described in sufficient detail, apart from the temperature and some pages missing from the report as presently available.
Principles of method if other than guideline:
Method: other
GLP compliance:
no
Radiolabelling:
yes
Vehicle:
no
Details on preparation of test solutions, spiked fish food or sediment:
Test Medium: Water drawn from a 125 m bedrock well

STOCK AND TEST SOLUTION AND THEIR PREPARATION:  Stock solutions were prepared by diluting known amounts of labelled and unlabelled test substance with distilled water. Diluter stock solutions were prepared by further dilution with distilled water. Test solutions were prepared using an intermittent-flow proprtional diluter.

TEST CONCENTRATIONS: 0.06 and 0.6 mg/l nominal (0.058 ± 0.01; 0.55 ± 0.16 mg/l measured)
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISMS: Size: 19 ± 2 cm Weight: 39 ± 3 g Pretreatment: acclimated for 30 days before testing. Cumulative mortality less than 2% during holding period Feeding: Dry pelleted ration twice daily ad libitum
Route of exposure:
aqueous
Total exposure / uptake duration:
49 d
Total depuration duration:
14 d
Hardness:
Hardness: 35 mg/l as CaCO3
Test temperature:
Temperature: 18 ± 1.0 °C
pH:
pH: 7.1
Dissolved oxygen:
Dissolved Oxygen Concentration: > 6.0 mg/l (60% saturation)
Details on estimation of bioconcentration:
ENDPOINTS: Bioaccumulation, elimination rate over a 14 day depuration period, and distribution between edible and non-edible tissues.
Conc. / dose:
0.06 mg/L
Type:
BCF
Value:
71 dimensionless
Basis:
non-edible fraction
Remarks on result:
other: Conc.in environment
Conc. / dose:
0.06 mg/L
Type:
BCF
Value:
< 7 dimensionless
Basis:
whole body d.w.
Remarks on result:
other: Conc.in environment
Conc. / dose:
0.6 mg/L
Type:
BCF
Value:
31 dimensionless
Basis:
non-edible fraction
Remarks on result:
other: Conc.in environment
Conc. / dose:
0.6 mg/L
Type:
BCF
Value:
< 2 dimensionless
Basis:
whole body d.w.
Remarks on result:
other: Conc.in environment
Elimination:
yes
Parameter:
other: After 14 days depuration, carp that had been exposed to 0.058 and 0.55 mg/l test substance had eliminated all measurable 14-C residues.
Depuration time (DT):
14 d
Details on results:
BIOACCUMULATION AT 0.06 mg/l NOMINAL TEST CONCENTRATION: A mean fish concentration of 4.1 mg/kg, equivalent to BCF = 71,  was determined for non-edible tissues, although no meaningful trends in bioaccumulation were observed at 7 sampling points over the exposure period. 

Analysis of the gut, faeces and visceral tissues at Day 42 showed that 94% of residues were present in faecal matter, 1% in the gut and 5% in the remaining visceral tissues, indicating that the substance was ingested and eliminated with very little accumulation.  

Expressed on a whole-body basis, the mean fish concentration was < 0.41 mg/kg, equivalent to BCF < 7.

BIOACCUMULATION AT 0.6 mg/l NOMINAL TEST CONCENTRATION: A similar pattern to the lower test concentration was observed. 
The mean fish concentration determined for non-edible tissues, equivalent to BCF = 31.  Analysis on Day 42 showed 83% in faecal matter, 2% in the gut and 15% in the remaining visceral tissues.  

Expressed on a whole-body basis, the mean fish concentration was < 1.0 mg/kg, equivalent to BCF < 2.

Measured values close to limits of detection, especially for whole body.
Conclusions:
The test substance did not bioaccumulate in the edible tissues of carp. Some accumulation of the test substance was
observed in the visceral tissues, although analysis revealed that most of this was associated with ingesta and faecal
material, indicating that the the substance was ingested and eliminated with very little accumulation.
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:
Please refer to Annex 3 of the CSR and IUCLID Section 13 for justification of read-across between members of the HEDP category.
Reason / purpose for cross-reference:
read-across source
Conc. / dose:
0.06 mg/L
Type:
BCF
Value:
71 dimensionless
Basis:
non-edible fraction
Remarks on result:
other: concentration in environment
Conc. / dose:
0.06 mg/L
Type:
BCF
Value:
< 7 dimensionless
Basis:
whole body d.w.
Remarks on result:
other: concentration in environment
Conc. / dose:
0.6 mg/L
Type:
BCF
Value:
31 dimensionless
Basis:
non-edible fraction
Remarks on result:
other: concentration in environment
Conc. / dose:
0.6 mg/L
Type:
BCF
Value:
< 2 dimensionless
Basis:
whole body w.w.
Remarks on result:
other: concentration in environment
Elimination:
yes
Parameter:
other: After 14 days depuration, carp that had been exposed to 0.058 and 0.55 mg/l test substance had eliminated all measurable 14-C residues.
Depuration time (DT):
14 d

Description of key information

A reliable study of bioaccumulation of HEDP-H in Cyprinus carpio indicates a bioconcentration factor of 71 for non-edible tissues (concentration level 0.06 mg/L, nominal). When expressed in terms of a whole body basis, the BCF is equivalent to <7. At a concentration level of 0.6 mg/L, a BCF value of 31 was determined for non-edible tissues, which is equivalent to <2 when expressed in terms of a whole body basis.

Key value for chemical safety assessment

BCF (aquatic species):
71 dimensionless

Additional information

A reliable aquatic bioaccumulation study has been read-across from HEDP-H (EG&G, 1976). In this study, BCF values of 71 and 31 for the concentration levels of 0.06 mg/L and 0.6 mg/L were determined for non-edible tissues. These values are equivalent to <7 and <2 when expressed in terms of a whole body basis. The study was conducted according to generally accepted scientific principles and was assigned a reliability rating of 2.

A supporting study with HEDP (2-3Na) reported extensive elimination of the test substance after 2 weeks in Danio rerio, reporting a BCF <1 (Steber and Wierich, 1986). In the same study, a steady state BCF was calculated on the basis of the uptake and clearance rate constants, which was BCF = 17.9. However, based on a lack of documentation, the study was assigned a reliability rating of 4.

The acid, sodium and potassium salts in the HEDP category are freely soluble in water and, therefore, the HEDP anion is fully dissociated from its sodium or potassium cations when in solution. Under any given conditions, the degree of ionisation of the HEDP species is determined by the pH of the solution. At a specific pH, the degree of ionisation is the same regardless of whether the starting material was HEDP-H, HEDP (1-2Na), HEDP (2-3Na), HEDP-4Na, HEDP-xK or another salt of HEDP.

 

Therefore, when a salt of HEDP is introduced into test media or the environment, the following is present (separately):

  1. HEDP is present as HEDP-H or one of its ionised forms. The degree of ionisation depends upon the pH of the system and not whether HEDP (1-2Na), HEDP (2-3Na), HEDP-4Na, HEDP-xK salts, HEDP-H or another salt was added.
  2. Disassociated sodium/potassium cations. The amount of sodium/potassium present depends on which salt was added.
  3. Divalent and trivalent cations have much higher stability constants for binding with HEDP than the sodium or potassium ions, so would preferentially replace them. These ions include calcium (Ca2+), magnesium (Mg2+) and iron (Fe3+). Therefore, the presence of these in the environment or in biological fluids or from dietary sources would result in the formation of HEDP-dication (e.g. HEDP-Ca, HEDP-Mg) and HEDP-trication (e.g. HEDP-Fe) complexes in solution, irrespective of the starting substance/test material.

In this context, for the purpose of this assessment, read-across of data within the HEDP Category is considered to be valid.