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.
Eye irritation
Administrative data
- Endpoint:
- eye irritation, 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 405 (Acute Eye Irritation / Corrosion)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- 3 adult female albino rabbits (3.1 to 3.7 kg)
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100µl
- Observation period (in vivo):
- 7, 14 and 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- "The eye irritancy of thymol (99.5% pure) was tested in 3 adult female albino rabbits (3.1 to 3.7 kg) in accordance with OECD guideline No. 405. Each animal had 100 µl (bulk weight approx. 60 mg) instilled into the conjunctival sac of one eye, which was rinsed out with physiological saline solution after 24 hours. The findings were scored in accordance with the Draize method 1hour after rinsing out the eyes and again after 24, 48 and 72 hours as well as 7, 14 and 21 days. The irritation scores were 2 to 2.3 for the conjunctivae,1.0 for the iris and 1.3 to 2.7 for the cornea. Up to day 21 of the observation period all of the animals had positive fluorescein test results, and as of day 14 of the observation period, two rabbits developed pannus while the third
showed swelling in the lower part of the eyeball. On the basis of these irreversible findings, thymol was evaluated as a strong irritant (Bayer, 1986 b)."
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 2.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 2.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 2.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1.3 - <= 2.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1.3 - <= 2.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1.3 - <= 2.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- <= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- <= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- <= 4
- Max. score:
- 4
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Up to day 21 of the observation perid all of the animals had positive fluorescein test results, and as of day 14 of the observation period, two rabbits developed pannus while the third showed swelling in the lower part of the eyeball. Thymol was evaluted as a strong irritant.
Moreover, thymol is listed is annex 6 of European Regulation 1272/2008 and the hazard class is Skin corr. 1B and is classified H314 so equally classified H318 by default.
The classification of thymol is category 1 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 (see above data). - 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 eye 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 eye corrosive (thymol at 51%).
The single constituent is present above the CLP generic concentration limit of 3% that triggers classification of the mixture. Therefore, the registered substance is classified as a eye 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
