Concrete of Salvia sclarea L. (Lamiaceae) obtained from leaves, flowers and twigs by apolar hydrocarbon solvent extraction with or without purification by molecular distillation

Endpoint summary

Description of key information

According to ECHA Guidance on the Application of the CLP Criteria (2017), Clary sage concrete can be classified as skin sensitizer based on its composition as skin sensitizer Cat1,

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

accepted calculation method

Qualifier:

no guideline required

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

Key result

Parameter:

other: Classification

Remarks on result:

other: Skin sensitizer category 1

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

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 or in vivo tests but some of its constituents are classified as skin sensitiser Cat.1B (Lynalil acetate, linalool, geranyl acetate, beta-caryophyllene and neryl acetate) and are 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 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 or in vivo tests but some of its constituents are classified as skin sensitisers 1B and are all 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 1 without further testing according to the Regulation (EC) No 1272/2008.

Constituent	CAS	Source
Linalyl acetate	115 -95 -7	ECHA C&L inventory and registration dossier –self classification
Linalool	78-70-6	ECHA C&L inventory and registration dossier–self classification
geranyl acetate	105 -87 -3	ECHA C&L inventory and registration dossier–self classification
beta-caryophyllene	87 -44 -5	ECHA C&L inventory and registration dossier–self classification
Neryl acetate	141 -12 -8	ECHA C&L inventory and registration dossier–self classification

Source: ECHA disseminated dossiers and self classification

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.