Registration Dossier
Registration Dossier
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EC number: 285-397-0 | CAS number: 85085-75-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thymus zygis, Labiatae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- classification based on calculation rules for mixtures of the CLP Regulation
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Classification based on calculation rules for mixtures of the CLP Regulation
Constituants data come from an online compilation using secondary data sources.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
- Reference Type:
- other: Harmonized classification
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- This method provides information on health hazard likely to arise from exposure to liquid or solid test substance by dermal application
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Thymol
- EC Number:
- 201-944-8
- EC Name:
- Thymol
- Cas Number:
- 89-83-8
- Molecular formula:
- C10H14O
- IUPAC Name:
- 5-(2-propenyl)-1,3-benzodioxole
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- 6 adult albino rabbits (3.0 to 3.4 kg)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 1, 24, 48 and 72 hours
- Observation period:
- 7 days and 14 days
- Number of animals:
- 6 adult of both sexes
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- "The primary skin irritancy of thymol (99.5% pure) was tested in 6 adult albino rabbits (3.0 to 3.4 kg) of both sexes in accordance with OECD guideline No. 404. They underwent a single semi-occlusive 4-hour exposure to 500mg of the test substance, made into a paste with water and applied to themechanically depilated flank skin. The findings were scored 1, 24, 48 and 72 hours as well as 7 and 14 days after the end of exposure. Thymol proved corrosive in all of the animals. The necrotic changes were irreversible in all of the animals up to the end of the observation period (Bayer, 1986 b)."
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- After the end of exposure, thymol proved corrosive in all of the animals. The necrotic were irreversible in all of the animals up to the end of the observation period.
Moreover, thymol is listed is annex 6 of European Regulation 1272/2008 and the hazard class is Skin corr. 1B and is classified H314.
The classification of thymol is category 1B according to CLP and GHS criteria.
No study was conducted on the thyme oil iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and thymol represents about 51% of this UVCB substance.
Literature above provided data for this major compound. - Executive summary:
The NCS is composed of several identified constituents, so 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 (2015) was used to determine the skin irritation / corrosion potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests.
But one of its constituents is classified as skin corrosive (thymol at 51%).
The single constituent is present above the CLP generic concentration limit of 5% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin corrosive substance without further testing according to the Regulation (EC) No 1272/2008
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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