Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

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-SE 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 CO2-SE Extract.

Ginger CO2-SE Extract has not been tested itself in vitro/in chemico or in vivo, but some individual constituents of Ginger CO2-SE Extract 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 CO2-SE 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

alpha zingiberene

495-60-3

23.00%

42.00%

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

2.00%

4.00%

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

0.50%

2.00%

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

reliability)