Piperidine

Toxicity to terrestrial plants

Administrative data

Endpoint:

toxicity to terrestrial plants: short-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
[Specific explanation in addition to field 'Justification for data waiving']
According to Regulation (EC) 1907/2006, Annex IX, Section 9.4.1 to 9.4.3, Column 2, studies on the toxicity to terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
For the substance only industrial and professional uses with adequate risk mitigating measures are foreseen. Environmental exposure through widespread uses by consumers is excluded. Widespread uses by professionals will mostly take place indoors. In case of outdoor scenarios, risk mitigating measures are implemented to reduce unintended exposure to insignificant amounts. The substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. In addition, adsorption to sewage sludge is not expected based on the low adsorption potential (see IUCLID Ch. 5.4.1); therefore, further reducing the risk of indirect transfer of the substance via sewage sludge.
In Annex XI, Section 3, it is laid down that testing in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI, Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are well below 1 for all compartments (see Chemical Safety Report Ch. 10).
Consequently, no tests on soil organisms are performed. The equilibrium partitioning method has been used for assessing the hazard to soil organisms in accordance with Annex IX, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))

GLP compliance:

not specified

Oxygen conditions:

aerobic

Inoculum or test system:

mixture of sewage, soil and natural water

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): mixture from different sources (sewage works, soil, rivers, lakes, sediments)
- Concentration of sludge: 30 mg/L

Duration of test (contact time):

14 d

Initial conc.:

100 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Parameter followed for biodegradation estimation:

test mat. analysis

Remarks:

(GC)

Parameter followed for biodegradation estimation:

TOC removal

Key result

Parameter:

% degradation (O2 consumption)

Value:

66.9

Sampling time:

14 d

Parameter:

% degradation (TOC removal)

Value:

96.9

Sampling time:

14 d

Parameter:

% degradation (test mat. analysis)

Value:

100

Sampling time:

14 d

Interpretation of results:

readily biodegradable

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

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 v5.14.1.5

2. MODEL (incl. version number)
CATALOGIC 301C v11.16

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 biodegradability of a substance Screening information on the ready biodegradability is required for substances manufactured or imported in quantities of 1 t/y or more. Depending on the results, further information may be required for substances manufactured or imported in quantities of 100 t/y or more (simulation testing on ultimate degradation in surface water/soil/sediment). Column 2 of REACH Annex VII provides exemptions for conducting the study. It does not need to be conducted if the substance is inorganic. According to column 2 of REACH Annex IX, testing is not required if the substance is highly insoluble in water, or the substance is readily biodegradable.
- See attached QPRF for reliability assessment.

Principles of method if other than guideline:

Estimation of ready biodegradation in water using CATALOGIC v5.14.1.5 BOD 28 days MITI (OECD 301C) v11.16

GLP compliance:

no

Oxygen conditions:

aerobic

Inoculum or test system:

other: model calculation

Duration of test (contact time):

28 d

Key result

Parameter:

% degradation (O2 consumption)

Value:

72

St. dev.:

0.047

Sampling time:

28 d

Concomitant predictions :
Ready degradable
Primary Half Life = 9.88 days
Ultimate Half Life = 15.18 days

 

Predicted value (model result): O2 -consumption (BOD) = 0.72 ± 0.0469

Interpretation of results:

readily biodegradable

Remarks:

according to OECD criteria

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

adsorption / desorption, other

Remarks:

adsorption

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable calculation method

Principles of method if other than guideline:

Calculation method determining the Koc for charged molecules according to Franco & Trapp (2008, 2009, 2010)

GLP compliance:

no

Type of method:

other: calculation of log Koc for ionized molecule

Media:

soil

Test temperature:

25 °C

Type:

Koc

Value:

219 L/kg

Temp.:

25 °C

Remarks on result:

other: pH 5 - 8

Type:

log Koc

Value:

2.34 dimensionless

Temp.:

25 °C

Remarks on result:

other: pH 5 - 8

The data refer to the charged molecule.