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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin irritation / corrosion, 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:
1 (reliable without restriction)
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:
Cardamom, ext.
EC Number:
288-922-1
EC Name:
Cardamom, ext.
Cas Number:
85940-32-5
Molecular formula:
Not applicable, UVCB
IUPAC Name:
1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 2-(4-methylcyclohex-3-en-1-yl)propan-2-yl acetate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Cardamom oil

Results and discussion

In vivo

Results
Irritation parameter:
other: classification
Remarks on result:
other: skin irritant category 2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The registered substance has more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Executive summary:

The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation.


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 irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.


 


 







































































ConstituentCASClassificationSource
Linalyl acetate115-95-7H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14484
Limonene138-86-3H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/24067
Linalool78-70-6H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14501/1
Beta-myrcene 123-35-3H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14795
Terpineol multiconstituent8000-41-7H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/16031/2/1
Geranyl acetate 105-87-3H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/5962
Terpineol-4 562-74-3H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/21354
Alpha pinene 80-56-8H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14724
Geraniol 106-24-1H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/14184
Geranial 141-27-5H315ECHA C&L inventory - self classification: https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/17552

 


Source: ECHA disseminated dossiers or self classification