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EC number: 282-006-5 | CAS number: 84082-60-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Matricaria recutita, Compositae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
- 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
Referenceopen allclose all
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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