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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

In vitro tests are considered incompatible. A paper on 'Scientific Justification about incompatibility of in vitro Skin sensitization studies' was joined on the endpoint summary report 'Calculations rules' to improve understanding of the strategy adopted.

According to ECHA Guidance on the Application of the CLP Criteria (2017), the substance can be classified as skin sensitizer based on its composition (eugenol and eugenyl acetate) classified as skin sensitizer Cat1, up to the generic concentration limit of 1%).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Parameter:
other: Classification
Remarks on result:
other: Skin sensitizer category 1
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The registered substance is classified as a skin sensitiser Cat. 1 without further testing according to the 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 sensitising potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro tests, because it is scientifically not justified to perform these tests as the results are not adequate to cover the endpoint skin sensitisation for REACH registration. In vitro tests are considered incompatible. A paper on 'Scientific Justification about incompatibility of in vitro Skin sensitization studies' was joined at this endpoint summary report to improve understanding of the strategy adopted.

Since some of its constituents are classified as skin sensitiser Cat.1B (eugenol, eugenyl acetate) and are present up to 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 without further testing according to the Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

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 the registered substance.

The registered substance has not been tested itself in appropriate in vitro tests, because it is scientifically not justified to perform these tests as the results are not adequate to cover the endpoint skin sensitisation for REACH registration. In vitro tests are considered incompatible. A paper on 'Scientific Justification about incompatibility of in vitro Skin sensitization studies' was joined at this endpoint summary report to improve understanding of the strategy adopted. Since, some of its constituents are classified as skin sensitiser 1B (eugenol and eugenyl acetate) and are present up to the CLP generic concentration limit of 1% that triggers classification of the mixture.

Therefore, the registered substance is classified as a skin sensitiser 1 without further testing according to the Regulation (EC) No 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the typical composition provided by the Lead Registrant, the registered substance is classified as skin sensitiser: Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.