Concrete of Rosa Damascena (Rosaceae) obtained from fresh flowers by extraction with an apolar solvent

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is marketed or used in a non solid or granular form

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING:
In accordance with column 2 of REACh Annex VII, the study does not need to be conducted if the substance is marketed or used in a non-solid or granular form. As presented under Section 4.1, the substance is an orange-red wax, not mobile. Therefore the study is scientifically not necessary.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19-25 October 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Data come from the description of the test substance in the GLP report on other physico-chemical properties. No guideline is required according to REACh TGD. The substance is considered to be adequately characterised. Therefore full validation applies.

Qualifier:

no guideline required

Principles of method if other than guideline:

Visual observation

GLP compliance:

yes (incl. QA statement)

Remarks:

GLP certificate (inspected on 13 and 14 October 2014 / signed on 8 April 2015)

Physical state at 20°C and 1013 hPa:

liquid

Remarks:

wax, not mobile but considered as liquid due to the results of the study related to the determination of the freezing point of the substance

Key result

Form:

other: wax, not mobile

Colour:

orange-red

Substance type:

organic

Conclusions:

The substance is an orange-red wax, not mobile at ambient temperature and atmospheric pressure.

Executive summary:

The data come from the description of the test substance reported in the GLP study reports on physico-chemical properties.