Non-volatile extract of Ginger, obtained from the roots of Zingiber officinalis (Zingiberaceae) by supercritical CO2 extraction

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Remarks:

Classification based on calculation rules for mixtures of the CLP Regulation

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Data source

Reference

Reference Type:

other: Guidance

Title:

Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures

Author:

ECHA

Year:

2017

Bibliographic source:

ECHA-17-G-21-EN

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Test material information

Constituent 1

Reference substance name:

Non-volatile extract of Ginger, obtained from the roots of Zingiber officinalis (Zingiberaceae) by supercritical CO2 extraction

IUPAC Name:

Non-volatile extract of Ginger, obtained from the roots of Zingiber officinalis (Zingiberaceae) by supercritical CO2 extraction

Test material form:

liquid

Details on test material:

Batch number: 861213

Results and discussion

In vitro / in chemico

Results

Key result

Parameter:

other: classification

Remarks on result:

other: Skin sensitizer category 1B

Applicant's summary and conclusion

Interpretation of results:

other: Skin sensitiser Category 1B

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

Ginger Hot Flavor CO2-TO extract contains a constituent that is classified as suspected skin sensitiser and is present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance needs to be classified as a skin sensitiser Cat. 1B.

Executive summary:

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the skin sensitising potential of Ginger Hot Flavor CO2-TO extract.

Ginger Hot Flavor CO2-TO extract has not been tested itself in vitro/in chemico or in vivo, but some individual constituents of Ginger Hot Flavor CO2-TO extract are suspected or have been classified as skin sensitizers Cat 1 B (see table) and are all present or potentially present above the generic concentration limit of 1 %. Therefore Ginger Hot Flavor CO2-TO Extract shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 127212008.

Source: ECHA disseminated dossiers

NAME	CAS	Ginger CO2-SE Extract		C&L inventory
6-gingerol	23513-14-6	25%	30%	Suspected skin sensitiser: CAESAR skin sensitisation model in VEGA (Q)SAR platform predicts that the chemical is Sensitizer (moderate reliability)