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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:
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

1
Reference substance name:
Rosemary, ext.
EC Number:
283-291-9
EC Name:
Rosemary, ext.
Cas Number:
84604-14-8
Molecular formula:
Not applicable for UVCB substance
IUPAC Name:
Essential oil of Rosmarinus officinalis L. (Lamiaceae) obtained from leaves, flowers and twigs by steam distillation
Test material form:
liquid

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:
other: Skin irrit. 2, H315
Remarks:
in accordance with EU CLP (EC 1272/2008 and its updates)
Conclusions:
The substance has more than 10% of constituents classified as Skin irritant Category 2 and should be classified as a skin irritant.
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 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.