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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
genetic toxicity in vitro, 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:
Concrete of Rosa Damascena (Rosaceae) obtained from fresh flowers by extraction with an apolar solvent
EC Number:
946-638-1
IUPAC Name:
Concrete of Rosa Damascena (Rosaceae) obtained from fresh flowers by extraction with an apolar solvent

Results and discussion

Test results
Key result
Species / strain:
other: not relevant
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: not relevant

Applicant's summary and conclusion

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 mutagenic potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as mutagenic Cat. 2 (methyl eugenol) and strictly present below the CLP generic concentration limit of 1% that triggers classification of the mixture. As none of the other constituents of the registered substance are classified for mutagenicity, the registered substance is not classified for mutagenicity, without further testing according to the Regulation (EC) No 1272/2008.