bis(hydrogenated tallow C16-18-alkyl)hydroxylamine

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-06-18 to 1999-09-03

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study. No depuration phase.

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

no depuration phase

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
48hr-LC50 to Orange killifish : > 10 mg/L

Radiolabelling:

yes

Details on sampling:

- Sampling intervals/frequency for test organisms:
After the start of the exposure test, 3 fish each were sampled from Concentration Level 1 and 2 in Weeks 2, 4, 6 and 8 and the concentration of the test substance in a fish body was measured using 2 fish of them. In Week 8, the measurement of Concentration Level 2 was also performed in the third fish because the preliminary measurement result to decide continuation of the test varied between 2 fish.

- Sampling intervals/frequency for test medium samples:
Concentrations of the test substance in water were measured periodically twice weekly.

Vehicle:

yes

Remarks:

HCO-20 and tetrahydrofuran

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

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 14C-radiolabeled compound was synthesized and used as tracer for the test, because it was difficult to analyze the test substance in water and fish by ordinary method.

The stock feed solution supplied to the dilution tank using a metering pump, mixed with the dilution water [dechlorinated water: dechlorinated water of Yokohama municipal tap water with activated charcoal (conformed to the water standard for fisheries)] supplied from the metering pump for the supply of the dilution water to adjust to the designated concentration of the test solution, and supplied to the breeding water tank.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Carp
- Fat content measured : 4.1 % (n=4, 3.5-4.6 %)

Test fish: Carp (Cyprinus carpio)
Source of supply: Sankyo Suisan Co., Ltd. (1-1 Ichigaya-tamachi, Shinjuku-ku, Tokyo)
Supply date: December 8, 1998
Lot: 98-K-1208

Body length: 9.4 – 12.2 cm
Body weight: 23.09 – 40.00 g

Water temperature: 25 ± 2 ºC (measured value for 1 week prior to the test)
Period: For at least 1 week
Food: Minipet, Kyorin Co., Ltd.
Feeding: 2% of fish body weight (every day except for holidays)
Ratio of dead fish in the week before the test: 0%

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

8 wk

Hardness:

not indicated

Test temperature:

not indicated

pH:

not indicated

Dissolved oxygen:

at least 4 mg/L

TOC:

not indicated

Salinity:

n/a

Details on test conditions:

TEST SYSTEM
Type of flow-through: Continuous flow-through diluter system
Volume of dilution water supplied: 300 L/day (about 7 exchanges/day; 45 L aquarium)
Volume of the stock feed solution supplied: Level 1: 12 mL/day, Level 2: 12 mL/day
Designated temperature: 25 ± 2 ºC
Dissolved oxygen concentration: At least 4 mg/L
Aeration: Aerated all the time.
Food type: Minipet, Kyorin Co., Ltd.
Feeding: 2% of fish body weight (every day except for holidays)

Breeding density (at the start of test):
Level 1: 22 fish/45 L breeding water
Level 2: 22 fish/45 L breeding water
Control level: 12 fish/45 L breeding water

Breeding period: 8 weeks (exposure)

Nominal and measured concentrations:

Nominal:
High exposure level: 0.01 mg/L
Low exposure level: 0.001 mg/L
Control: 0 µg/mL

Measured:
High exposure level: 0.0099 to 0.0101 µg/mL
Low exposure level: 0.00103 to 0.00109 µg/mL

Reference substance (positive control):

no

Details on estimation of bioconcentration:

No depuration phase.

Conc. / dose:

0.01 mg/L

Type:

BCF

Value:

>= 27 - <= 153 dimensionless

Basis:

not specified

Calculation basis:

steady state

Remarks on result:

other:

Conc. / dose:

0.001 mg/L

Type:

BCF

Value:

>= 27 - <= 87 dimensionless

Basis:

not specified

Calculation basis:

steady state

Remarks on result:

other:

Results with reference substance (positive control):

no reference substance

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

1. SOFTWARE
OASIS Catalogic v5.12.1

2. MODEL (incl. version number)
BCF base-line model v02.09 - July 2017

3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.

4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.

5. APPLICABILITY DOMAIN
See attached QPRF.

6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the Bioconcentration factor (BCF) as required information point according to Regulation (EC) No 1907/2006 [REACH], Annex IX, 9.3.2 Bioaccumulation in aquatic species (preferably fish);
further related predictions: Apparent effect of mitigating factors / Maximum bioconcentration factor (BCFmax) / Maximum diameter of energetically stable conformers / Whole body primary biotransformation half-life / Metabolic biotransformation rate constant Km / Metabolites and their quantitative distribution
- See attached QPRF for reliability assessment.

Principles of method if other than guideline:

Calculation using Catalogic v.5.12.1, BCF base-line model v.02.09

GLP compliance:

no

Details on estimation of bioconcentration:

BASIS FOR CALCULATION OF BCF
- Estimation software: OASIS Catalogic v5.12.1 [BCF base line model - v.02.09]

Key result

Type:

BCF

Value:

7.4 L/kg

Remarks on result:

other: considering all mitigating factors; the substance is not completely within the applicability domain of the model.

Type:

BCF

Value:

9.4 L/kg

Remarks on result:

other: BCF max: without considering any mitigating factors; the substance is not completely within the applicability domain of the model.

Reference 3

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

1. SOFTWARE
OASIS Catalogic v5.12.1

2. MODEL (incl. version number)
BCF base-line model v02.09 - July 2017

3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.

4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.

5. APPLICABILITY DOMAIN
See attached QPRF.

6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the Bioconcentration factor (BCF) as required information point according to Regulation (EC) No 1907/2006 [REACH], Annex IX, 9.3.2 Bioaccumulation in aquatic species (preferably fish);
further related predictions: Apparent effect of mitigating factors / Maximum bioconcentration factor (BCFmax) / Maximum diameter of energetically stable conformers / Whole body primary biotransformation half-life / Metabolic biotransformation rate constant Km / Metabolites and their quantitative distribution
- See attached QPRF for reliability assessment.

Principles of method if other than guideline:

Calculation using Catalogic v.5.12.1, BCF base-line model v.02.09

GLP compliance:

no

Details on estimation of bioconcentration:

BASIS FOR CALCULATION OF BCF
- Estimation software: OASIS Catalogic v5.12.1 [BCF base line model - v.02.09]

Key result

Type:

BCF

Value:

7.4 L/kg

Remarks on result:

other: considering all mitigating factors; the substance is within the applicability domain of the model.

Type:

BCF

Value:

9.3 L/kg

Remarks on result:

other: BCF max: without considering any mitigating factors; the substance is within the applicability domain of the model.

Reference 4

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

1. SOFTWARE
OASIS Catalogic v5.12.1

2. MODEL (incl. version number)
BCF base-line model v02.09 - July 2017

3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See section 'Test Material'.

4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF.

5. APPLICABILITY DOMAIN
See attached QPRF.

6. ADEQUACY OF THE RESULT
- The model is scientifically valid (see attached QMRF).
- The model estimates the Bioconcentration factor (BCF) as required information point according to Regulation (EC) No 1907/2006 [REACH], Annex IX, 9.3.2 Bioaccumulation in aquatic species (preferably fish);
further related predictions: Apparent effect of mitigating factors / Maximum bioconcentration factor (BCFmax) / Maximum diameter of energetically stable conformers / Whole body primary biotransformation half-life / Metabolic biotransformation rate constant Km / Metabolites and their quantitative distribution
- See attached QPRF for reliability assessment.

Principles of method if other than guideline:

Calculation using Catalogic v.5.12.1, BCF base-line model v.02.09

GLP compliance:

no

Details on estimation of bioconcentration:

BASIS FOR CALCULATION OF BCF
- Estimation software: OASIS Catalogic v5.12.1 [BCF base line model - v.02.09]

Key result

Type:

BCF

Value:

7.4 L/kg

Remarks on result:

other: considering all mitigating factors; the substance is not completely within the applicability domain of the model.

Type:

BCF

Value:

12.2 L/kg

Remarks on result:

other: BCF max: without considering any mitigating factors; the substance is not completely within the applicability domain of the model.

Description of key information

Does not accumulate in organisms.

Additional information

To assess the bioaccumulation potential of the test substance, a GLP study following the procedures of the OECD guideline 305 C is available. In this flow-through test using Cyprinus carpio as test species a BCF < 153 for the whole test material was determined (Mitsubishi Chemical Safety Institute LTD 8B772G, 1999).

Additionally, QSAR calculations with the main component and two relevant by-products have been conducted with Catalogic v5.12.1, BCF base-line model v.02.09. Taking all mitigating factors into account, the BCF was < 10 for all three compounds. Even the BCF max. was well below 20. The average maximum diameter was >> 1.7 nm which is further proof that uptake through biological membranes is negligible (ECHA Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT/vPvB assessment).

Therefore, none of the components of the substance is expected to be bioaccumulative. The BCF is << 500.