Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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

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)