Piperazine

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:

From November 8, 1978 to March 30, 1979

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Original data are translated from Japanese.

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)

Version / remarks:

Bioaccumulation test of chemical substances in fish and sellfish" described in "Kanpogyou, No.5", "Yakuhatsu, No.615" and "49 Kikyoku, No.392

GLP compliance:

yes

Radiolabelling:

no

Details on sampling:

- Sampling intervals/frequency for test organisms: twice weekly during the exposure period for both high and low concentrations

Vehicle:

no

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

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:1 g Test substance was dissolved in 1000 mL ion-exchanged water to prepare 1000 ppm (w/v) stock solution.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Length at study initiation (length definition, mean, range and SD): 10 cm
- Weight at study initiation (mean and range, SD): 27 g
- Lipid content at test initiation (mean and range, SD): 2-6 %
- Health status: health
- Description of housing/holding area: The fish were bathed for 24 hours in a static, medicated bath comprising 10 ppm aqueous chlortetracycline hydrochloride solution.
- Feeding during test An amount of corresponding to about 2% of the test fish bodyweight was fed twice daily in halves. Feeding was stopped on the day before sampling

ACCLIMATION
- Acclimation period: 21 days
- Acclimation conditions (same as test or not): same

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

6 wk

Test temperature:

25 +- 2 °C

Dissolved oxygen:

6-8 mg/L (in accordance with the test guideline)

Details on test conditions:

TEST SYSTEM
- Test vessel: water tank
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass tank of 100 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 579L/day (stock solution : dilution water = 4 mL/minute : 400 mL/minute)
- No. of organisms per vessel: 20
- Biomass loading rate: 0.013 g/L

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: 1000 mg/L
- Results used to determine the conditions for the definitive study: 48 EC50 >= 1000 mg/L

TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: twice a week

Nominal and measured concentrations:

Nominal: 0.1 and 1 mg/L
Measured: 0.09 and 1.02 mg/L

Key result

Conc. / dose:

0.1 mg/L

Temp.:

25 °C

Type:

BCF

Value:

<= 0.3 L/kg

Basis:

whole body w.w.

Calculation basis:

steady state

Key result

Conc. / dose:

0.01 mg/L

Temp.:

25 °C

Type:

BCF

Value:

<= 3.9 L/kg

Basis:

whole body w.w.

Calculation basis:

steady state

Table 1. Accumulation factor of test substance

	2 W	3 W	4 W	6 W
First concentration group / Replicate 1	≤0.3	≤0.3	≤0.3	≤0.3
Replicate 2	≤0.3	(0.9)	≤0.3	(0.6)
Second concentration group / Replicate 1	≤3.9	≤3.9	≤3.9	≤3.9
Replivate 2	≤3.9	≤3.9	≤3.9	≤3.9

Not reliable value, lower than LOD: displayed in brackets ( )

Validity criteria fulfilled:

yes

Description of key information

Significant accumulation of CAS 110-85-0 in organisms is not to be expected. 

Additional information

QSAR-disclaimer:

In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.

Furthermore, according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.

According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.

For the assessment of the substance (Q)SAR results were used for aquatic bioaccumulation. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.

Therefore, and for reasons of animal welfare, further experimental studies on aquatic bioaccumulation are not provided.

 

Assessment:

In order to assess the bioaccumulation potential of the test substance, the experimental bioaccumulation study, performed by Ministry of the Environment (MOE), Japan or National Institute of Technology and Evaluation (NITE) is available. This GLP study was conducted under flow-through conditions.  According to this data the experimental BCF value of <= 3.9 L/kg was determined (NITE, 1979). This experimental result was supported with the estimation model: QSAR BCF baseline v4.11 (OASIS CATALOGIC v5.14.1.5).  The model estimated a BCF of 9.3 L/kg without considering mitigation factors. But, metabolism, water solubility and, for a minor part, molecular size reduce the  BCF to 3.02 L/kg as estimated by the model. The test substance is to 100% within the applicability domain of the model (BASF SE, 2020).

Based on the available experimental data along with the supported calculated BCF data it can be concluded that significant accumulation of CAS 110-85-0 in organisms is not to be expected.