3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]

Adsorption / desorption

Administrative data

Endpoint:

adsorption / desorption: screening

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
see attached justification

Cross-reference

Cross-reference 1

Reason / purpose:

data waiving: supporting information

Remarks:

dispersion stability

Reference

see endpoint study record in chapter 5.6

Cross-reference 2

Reason / purpose:

data waiving: supporting information

Remarks:

dispersion stability

Reference

The study of Pigment Yellow 128 according to the mentioned guideline was not possible due to its insufficient wetting with water.

→ Details refer to the endpoint 5.7

The OECD TG 318 on Dispersion Stability of Nanomaterials in Simulated Environmental Media is the first nano-specific test guideline, published 2017. Here we applied it to an organic pigment in order to map the ranges of stability in different media of surface water.

→ The study record maintained at the endpoint 5.7

Cross-reference 3

Reason / purpose:

data waiving: supporting information

Remarks:

dispersion stability

Reference

Endpoint:

additional information on environmental fate and behaviour

Remarks:

Dispersion stability in simulated environmental media

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to

Guideline:

other: OECD 318

GLP compliance:

no

The preparation of a stock solution was not successful. The resulting suspension is heterogeneous with most of the pigment accumulated in a foam-like upper phase. It is an indication that the pigment is too hydrophobic and thus it is not sufficiently wetted by water. This makes it impossible to perform all other steps in accordance to the guideline TG-318. Thus the evaluation of the stability of Pigment Yellow 128 in simulated environmental media is not possible.

Executive summary:

The study is technically not feasible.

Cross-reference 4

Reason / purpose:

data waiving: supporting information

Remarks:

logKow

Reference

Estimated based on solubility ratio:

log Pow= <0 at 23°C

The Log Pow was determined following the ETAD guideline ETAD-299 based on the water solubility method OECD 105.

The test substance is almost insoluble in water as well as in n-Octanol therefore it is not possible to determine the log Pow experimentally by the shake flask method nor by HPLC method.

Cross-reference 5

Reason / purpose:

data waiving: supporting information

Remarks:

logKow

Reference

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

according to

Guideline:

other: based on the ETAD guideline ETAD-229, which in turn is based in part on the water solubility method (shaken flask) OECD 105.

Principles of method if other than guideline:

calculation based on solubility ratio

GLP compliance:

no

Type of method:

estimation method (solubility ratio)

Partition coefficient type:

octanol-water

Analytical method:

high-performance liquid chromatography

Key result

Type:

log Pow

Partition coefficient:

< 0

Temp.:

23 °C

Remarks on result:

other: no data on pH

Details on results:

The solubilities of the pigment at 23°C are recorded below:
Solubility in water: <25 µg/L
Solubility in n-octanol: <25 µg/L

The solubility is lower the detection limit of 25 µg/L.

Estimation based on individual solubilities:

Pow= C(n-octanol) / C(water)= <25 µg/L / <25 µg/L = <1

log Pow= <0

Conclusions:

The partition coefficient of test substance was estimated to be log Pow= <0 at 23°C