Rosemary, ext.

Endpoint summary

Description of key information

Skin sensitisation (Exisiting data on the sensitising properties of the constituents): Skin sensitiser 1B

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

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 1B

Interpretation of results:

other: Skin sensitiser Category 1B

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

Rosemary oil contains constituents that are classified as skin sensitisers Cat.1B and are all potentially 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. 1B.

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 sensitisers Cat.1B and are all potentially 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. 1B 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 Rosemary oil.

Rosemary oil has not been tested itself in an appropriate in vitro/in chemico or animal test, but in a human case-report (Dharmagunawardena, 2002), one patient presented with suspected allergic contact dermatitis showed a positive reaction (oedematous/vesicular reaction) with Rosemary oil. α-pinene, terpineol, linalool and carophylene were identified as the key allergens present in the sample of Rosemary oil tested. Moreover, some constituents of Rosemary oil have been classified as Skin Sensitiser Cat. 1 or Cat 1B (see table) and are all present or potentially present above the generic concentration limit of 1%. Therefore Rosemary oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 .

 

Source: ECHA disseminated dossiers

Name	CAS	Rosemary oil min-max range of both qualities (Spanish and North African together)		C&L inventory
1,8-cineole	470-82-6	16%	56%	Skin Sens. 1B
alpha pinene	80-56-8	7%	26%	Skin Sens. 1
limonene	138-86-3	0.50%	7%	Skin Sens. 1
beta pinene	127-91-3	1%	12%	Skin Sens. 1B
caryophyllene-beta	87-44-5	0%	9.50%	Skin Sens. 1B
linalool	78-70-6	0%	4%	Skin Sens. 1B

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

The substance is not a respiratory sensitiser in absence of human data indicating such effects. In addition, the respiratory sensitisation is assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-2, 2014).

1)     The substance is a skin sensitiser;

2)     The substance does not belong to the di-isocyanates;

3)     the substance has no structural alerts or is structurally related to chemicals causing respiratory sensitisation as presented in Table R.7.3-1 in the ECHA guidance of 2008 or those provided in the following document: http://ec.europa.eu/health/scientific_committees/docs/annex6_respiratory.pdf

Therefore the substance is not considered to be a respiratory sensitiser.

Justification for classification or non-classification

Based on the available information, the substance should be classified as sensitising to the skin (Skin Sens. 1B / H317) in accordance with the criteria outlined in the EU CLP Regulation (1272/2008/EC and its amendments). In absence human data indicating respiratory sensitisation and using the ITS in the ECHA guidance (R.7a, 2014) the substance is not considered to be a respiratory sensitiser in accordance with the criteria outlined in the EU CLP (EC 1272/2008 and its amendments)