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Toxicological information

Skin sensitisation

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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:
Ginger, ext.
EC Number:
283-634-2
EC Name:
Ginger, ext.
Cas Number:
84696-15-1
Test material form:
liquid
Details on test material:
Batch 10300009
Typical 46% Gingerols(6-,8-,10-) and Shogaols (6-8-) similar to Ginger Hot Flavor CO2-TO

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 1
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
Ginger CO2-Total Extract contains constituents that are classified as skin sensitisers Cat.1 and are all potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1
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 oil CO2-Total Extract. The substance not been tested itself in vitro/in chemico or in vivo, but some individual constituents are suspected or have been classified as skin sensitizers (see table) and are all present or potentially present above the generic concentration limit of 1 %. Therefore Ginger oil CO2-Total 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 -Total Extract

C&L inventory

alpha zingiberene

495-60-3

5.00%

21.00%

Has been notified as H317 in the C&L inventory, and indicated as a suspected skin sensitiser in the Annex III inventory: CAESAR skin sensitisation model in VEGA (Q)SAR platform predicts that the chemical is Sensitizer (good reliability)

Citral

5392·40-5

0.50%

3.00%

Has been notified as H317 in the C&L inventory, and subject to harmonised classification H317 as Skin Sens. 1A, H317

6-gingerol

23513-14-6

11%

22%

Suspected skin sensitiser: CAESAR skin sensitisation model in VEGA (Q)SAR platform predicts that the chemical is Sensitizer (moderate

reliability)

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