N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide

Hydrolysis

Administrative data

Endpoint:

hydrolysis

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is highly insoluble in water

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Waiving according to "column 2" in Annex VIII of REGULATION (EC) No 1907/2006 (substance is highly insoluble in water).
According to Appendix R7-1 for nanomaterials applicable to Chapter R7b (Endpoint specific guidance) Version 2.0 - May 2017, 'The chemical structure of the nanomaterial and whether it contains functional groups which could be subject to hydrolysis dictate whether a hydrolysis test is necessary or appropriate. If the nanoparticle is coated or functionalised, then abiotic degradation, e.g. hydrolysis of the substance, must be considered.' However, the nanoform is not functionalised and has no surface treatment. Thus, the study is not deemed necessary.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Test procedure according to method of Analytical Expert Group ETAD (Ecological and Toxicological Association of Dyes and Organic Pigment Manufacturers).

Principles of method if other than guideline:

Determination of water solubility.
The analytical method for the determination is in agreement with the method that was agreed upon at the Analytical Experts Meeting of ETAD (Basel) on January 12, 2005.

Type of method:

flask method

Key result

Water solubility:

10 µg/L

Temp.:

21 °C

pH:

ca. 6

Remarks on result:

other: The determination of water solubility was conducted at ambient temperature (21-22 °C)

Details on results:

The value above represents the mean from 2 determinations (sigma=1). See below for indidividual results.

Individual results:

	Absorption (d = 10 cm)	µg/L	pH
a1	0.0079	11	6.1
a2	0.0064	9	5.9

Conclusions:

Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The test substance has a water solubility of 10 µg/L.

Executive summary:

The water solubility was determined by UV-Vis analysis of the dissolved test substance amount in 30 mL water according to the method that was agreed upon at the Analytical Experts Meeting of ETAD (Basel) on January 12, 2005.

The test substance has a water solubility of 10 µg/L (21 -22 °C).