Matricaria recutita, ext.

Endpoint summary

Description of key information

- Human patch tests: potential skin sensitiser (Section 7.10.4: WOE with 3 studies, rel.2, Rudzki et al. 1976, 1977 and 1986)

- QSAR: Skin sensitiser Cat. 1B (WOE, QSAR Toolbox, rel.2)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation, other

Remarks:

QSAR approach

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Study period:

09-03-218

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Remarks:

No QPRF report was provided as model output.

Justification for type of information:

1. SOFTWARE
OECD QSAR Toolbox

Qualifier:

no guideline followed

Principles of method if other than guideline:

Following Skin Sensitisation relevant profilers were applied using OECD QSAR Toolbox v4.1 to identify if any structural alerts for protein binding were triggered for the query chemical.
• Protein binding by OASIS
• Protein binding by OECD
• Protein binding potency
• Protein binding potency Cys (DPRA 13%)
• Protein binding potency Lys (DPRA 13%)
• Keratinocyte gene expression
• Protein binding alerts for skin sensitisation by according to GHS
• Protein binding alerts for skin sensitisation by OASIS
• Protein binding potency h-CLAT

GLP compliance:

no

Key result

Parameter:

other: Classification

Remarks on result:

positive indication of skin sensitisation

Remarks:

Skin sensib 1B

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

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 (Bisabolone Oxide A, CAS N° 22567-38-0) and is 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.

Executive summary:

(E)-beta Farnesene (and Farnesene) is not considered in this assessment as it has been shown to be negative for Skin sensitization ( IFRA/IOFI Labeling Manual 2015).

Regarding the profile of all the major constituants (superior to 1%), we conclude that only one constituant is classified as Skin Sensib 1B: Bisabolone Oxide A.

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 (Bisabolone Oxide A, CAS N° 22567-38-0) and is 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.

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Reason / purpose for cross-reference:

reference to other study

Reason / purpose for cross-reference:

reference to other study

Reason / purpose for cross-reference:

reference to other study

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Weight-of evidence approach:

- Patients with dermatitis were treated in different studies (See Section 7.10.4) with a fragrance mixture, essential oils, and individual substances, at 2% in yellow paraffin, to identify the potential skin sensitisers comprised in cosmetics.

German chamomile has shown a skin sensitising potential in all of the three studies.

- A constituants approach was made using the OECD QSAR Toolbox which confirms the skin sensitising potential of the registered substance. Indeed, some of its constituents are classified as skin sensitisers Cat.1B (Bisabolone Oxide A, CAS N° 22567-38-0) and is potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture.

Conclusion: Skin sensitiser 1B

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Harmonised classification:

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

Self-classificaiton:

Based on the available data, the substance is classified as Skin Sens. 1B (H317: May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No data was available regarding respiratory sensitisation.