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EC number: 201-944-8 | CAS number: 89-83-8
- 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
The endpoint 'Skin sensitisation' is waived based on the classification as Skin Corr. 1B (H314). As supporting information several studies are available. The key results of these studies are as follows:
Guinea pig, Open Epicutaneous Test (OET), Draize Test (DT), Maximisation Test (MT), Freund's Complete Adjuvant Test (FCAT): negative (Klecak 1977, Ishihara 1986)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Principles of method if other than guideline:
- In a Freund's complete adjuvant test (Fdoses of 0.05 ml of the undiluted compound mixed with the same volume of FCA (Freund's complete adjuvant) were injected intradermally into the neck on days 0, 2, 4, 7, and 9 (total dose 250 mg). All the animals were tested epicutaneously on days 21 and 35.
- GLP compliance:
- no
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- The study was published in the year 1977. At this time-point no valid guideline for an LLNA was available.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: 0.05 ml undiluted compound mixed with the same volume of FCA
- Concentration / amount:
- induction: 0.05 ml on day 0,2,4,7,and 9 (total dose 250 mg)
challenge: subirritant concentration - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.05 ml undiluted compound mixed with the same volume of FCA
- Concentration / amount:
- induction: 0.05 ml on day 0,2,4,7,and 9 (total dose 250 mg)
challenge: subirritant concentration - No. of animals per dose:
- 6
- Details on study design:
- Doses of 0.05 ml of the undiluted compound mixed with the same volume of FCA (Freund's complete adjuvant) were injected intradermally into the neck on days 0, 2, 4, 7, and 9 (total dose 250 mg). The control animals were similarly treated with 5 x 0.05 ml of FCA alone. All the animals were tested epicutaneously on days 21 and 35 at a subirritant concentration in petrolatum .
- Group:
- test chemical
- Remarks on result:
- other: Thymol was not sensitizing at 10%. Higher concentrations were not used because of systemic toxicity.
- Group:
- positive control
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- Benzyl alcohol, Benzyl cinnamate, carvacrol, cinnamic aldehyde, citral, citronellal, cuminic aldehyde, geraniol, iso-eugenol, limonene, methyl cinnamate, methyl heptane carbonate, phenylacetaldehyde, phenyl-ethyl salicylate, 3-phenyl-propionaldehyde, 10-undecanal, benzaldehyde, cinnamic alcohol, vanilin.
- Group:
- negative control
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- Solvents, like water, ethanol and acetone, even when applied repeatedly, yielded no macroscopically detectable alteration on the treated skin. When other bases were applied, like Vaseline, diethyl phthalate or polyethylene glycol, additional controls for the vehicles were set in.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a Freund's complete adjuvant test doses of 0.05 ml of the undiluted compound mixed with the same volume of FCA (Freund's complete adjuvant) were injected intradermally into the neck on days 0, 2, 4, 7, and 9 (total dose 250 mg). The control animals were similarly treated with 5 x 0.05 ml of FCA alone. All the animals were tested epicutaneously on days 21 and 35 at a subirritant concentration in petrolatum. Thymol was netative in this test.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no guideline study,
- Principles of method if other than guideline:
- The minimum skin irritation concentration of the test substance was determined in an open epicutaneous test;
induction: 6-8 guinea pigs/dose group, undiluted or 30, 10, 3, 1, 0.3, 0.1, 0.03, 0 % solution, 21 d;
challenge: d 21 and d 35 - GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The study was published in the year 1977. At this time-point no valid guideline for an LLNA was available.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone, ethanol, diethyl phthalate, etc.
- Concentration / amount:
- undiluted, 30, 10, 3, 1, 0.3, 0.1, or 0.03%
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone, ethanol, diethyl phthalate, etc.
- Concentration / amount:
- undiluted, 30, 10, 3, 1, 0.3, 0.1, or 0.03%
- No. of animals per dose:
- 6
- Group:
- test chemical
- Remarks on result:
- other: Thymol was not sensitizing at 10%. Higher concentrations were not used because of systemic toxicity.
- Group:
- negative control
- Remarks on result:
- other: see 'Remark'
- Remarks:
- Solvents, like water, ethanol and acetone, even when applied repeatedly, yielded no macroscopically detectable alteration on the treated skin. When other bases were applied, like Vaseline, diethyl phthalate or polyethylene glycol, additional controls for the vehicles were set in.
- Group:
- positive control
- Remarks on result:
- other: A total of 32 compounds described in the literature as allergenic for man were tested by the OET. Of the compounds tested, all those with well-established allergenicity for man were detected by the OET.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Thymol was tested undiluted as well as dissolved in acetone, ethanol, diethylphthalate, etc., at concentrations of 30, 10, 3, 1, 0.3, 0.1, and 0.03 per cent in order to establish a dose-response curve making it possible to determine the minimal irritating and the maximal tolerated concentrations on an 'all or none' basis. Induction period: On day 0, 0.1 ml of undiluted thymol and of its progressively diluted solutions was applied to an area of measuring 8 cm² on the clipped flank skin of 6 to 8 guinea pigs per concentration group, using 4 to 6 groups for each compound. The applications were repeated daily for 21 days, always using the same skin site. The application site was left uncovered and the reactions were read 24 h after each application. The maximum nonirritant and the minimal irritating concentrations were determined. Challenge procedure: to determine wheather or not allergic contact dermatitis was induced, all groups of guinea pigs previously treated for 21 days as described above as well as 6 to 8 untreated controls for each compound, were tested on days 21 and 35 on the contralateral flank with the same compound at the minimal irritating concentration and at some lower nonirritant concentrations.Thymol was negative in this test
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: according to: Magnusson B, Kligman AM (1969), The identification of contact allergens by animal assay. The guinea pig maximization-test, J. Invest. Dermatol., 52, p. 269-276
- Principles of method if other than guideline:
- according to: Kligman, J. Invest. Dermatol. 52, 268-276 (1969)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was published in the year 1977. At this time-point no valid guideline for an LLNA was available.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- induction: 0.1 ml of a 5 % solution (intradermally) and in addition , 250 mg of a 25% solution in petrolatum (epicutan)
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- challenge: subirritant concentration (epicutan)
- No. of animals per dose:
- 6
- Group:
- test chemical
- Remarks on result:
- other: Thymol was not sensitizing at 10%. Higher concentrations were not used because of systemic toxicity.
- Group:
- positive control
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- Benzyl cinnamate, carvacrol, cinnamic aldehyde, citral, citronellal, cuminic aldehyde, geraniol, heliotropin, iso-eugenol, limonene, methyl cinnamate, methyl heptane carbonate, phenylacetaldehyde, phenyl-ethyl salicylate, benzaldehyde, cinnamic alcohol, vanilin
- Group:
- negative control
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- Solvents, like water, ethanol and acetone, even when applied repeatedly, yielded no macroscopically detectable alteration on the treated skin. When other bases were applied, like Vaseline, diethyl phthalate or polyethylene glycol, additional controls for the vehicles were set in.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A maximisation test according Magnusson and Kligman was conducted. On day 0 the animals were injected intradermally with 0.1 ml of a 5 per cent solution of the compound tested, with 0.1 ml of a 5 per cent emulsion of the same compound in Freund's Complete Adjuvant (FCA) and with 0.1 ml of FCA alone, each injection being given twice. In addition, 250 mg of the compound dissolved in petrolatum at a concentration of 25 per cent, which always causes mild to moderate skin irritation under occlusion, was applied on day 8 to a clipped skin area of the neck and was kept under occlusive bandage for 2 days (total dose 20 mg intradermally plus 250 mg epicutaneously). On day 21 an occlusive patch test with the compound at a subirritant concentration in petrolatum was applied to the flank for 24 hours. The reactions were read 24 and 48 h after removing the patch.Thymol was negative in the test.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only summary - original paper in Japanese
- Principles of method if other than guideline:
- thymol was tested in the GPMT
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was published in the year 1977. At this time-point no valid guideline for an LLNA was available.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- induction: 10 %
- Route:
- other: epicutaneous
- Vehicle:
- not specified
- Concentration / amount:
- 10%
- No. of animals per dose:
- no data
- Group:
- test chemical
- Remarks on result:
- other: induction: 10 %; challenge: 10 %; rate: II; score: 0.1%
- Group:
- negative control
- Remarks on result:
- other: no data
- Group:
- positive control
- Remarks on result:
- other: no data
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
Thymol was tested in the GPMT. In this test thymol was negative
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Method according to Draize JH (1959), Appraisal of the safety of chemicals in foods, drugs and cosmetics. Dermal toxicity, The assoc. of food and drug officials of the United States. Texas State Dept. of Health, Austin, p.46-59
- Principles of method if other than guideline:
- A dose of 0.05 ml of a 0.1 per cent solution of the compound tested in isotonic saline was injected intradermally on day 0 and further doses of 0.1 ml each were injected on 9 alternate days (total dose = 0.95 mg). The treated animals and untreated controls were challenged intradermally with 0.05 ml of a 0.1 per cent solution on days 35 and 49. The evaluation criterion was the mean diameter of the papular reactions.
according to Draize, Appraisal of the safety of chemicals in foods, drugs and cosmetics; dermal toxicity; The Assoc. of Food Drug Officials of the U.S., Texas State Dep. of Health, Austin, 1959, pp 46-59 - GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- The study was published in the year 1977. At this time-point no valid guideline for an LLNA was available.
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: isotonic saline
- Concentration / amount:
- induction: 0.1%
- Route:
- intradermal
- Vehicle:
- other: isotonic saline
- Concentration / amount:
- challenge: 0.1%
- No. of animals per dose:
- 6
- Group:
- test chemical
- Remarks on result:
- other: Thymol was not sensitizing at 10%. Higher concentrations were not used because of systemic toxicity.
- Group:
- positive control
- Remarks on result:
- other: Benzyl cinnamate, cinnamic aldehyde, cuminic aldehyde, iso-eugenol, methyl cinnamate, phenylacetaldehyde, benzaldehyde
- Group:
- negative control
- Remarks on result:
- other: see 'Remarks'
- Remarks:
- Solvents, like water, ethanol and acetone, even when applied repeatedly, yielded no macroscopically detectable alteration on the treated skin. When other bases were applied, like Vaseline, diethyl phthalate or polyethylene glycol, additional controls for the vehicles were set in.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A dose of 0.05 ml of a 0.1 per cent solution of the compound tested in isotonic saline was injected intradermally on day 0 and further doses of 0.1 ml each were injected on 9 alternate days (total dose = 0.95 mg). The treated animals and untreated controls were challenged intradermally with 0.05 ml of a 0.1 per cent solution on days 35 and 49. The evaluation criterion was the mean diameter of the papular reactions. Thymol was negative in this test
Referenceopen allclose all
Thymol was negative in the Freund's complete adjuvant test (individual scores not mentioned).
Thymol was tested undiluted as well as dissolved in acetone, ethanol,diethylphthalate, etc., at concentrations of 30, 10, 3, 1, 0.3, 0.1, and 0.03 per cent in order to establish a dose-response curve making itpossible to determine the minimal irritating and the maximal tolerated concentrations on an 'all or none' basis. Induction period: On day 0, 0.1 ml of each undiluted compound and of itsprogressively diluted solutions was applied to an area of measuring 8 cm² on the clipped flank skin of 6 to 8 guinea pigs per concentration group, using 4 to 6 groups for each compound. The applications were repeated daily for 21 days, always using the same skin site. The application site was left uncovered and the reactions were read 24 h after each application. Challenge procedure: to determine wheather or not allergic contact dermatitis was induced, all groups of guinea pigs previously treated for 21 days as described above as well as 6 to 8 untreated controls for each compound, were tested on days 21 and 35 on the contralateral flank with the same compound. Thymol was was negatve in the OET (individual scores not mentioned).
thymol was negative in the maximisation test (individual scores not mentioned).
Sensitization to thymol:
guinea pig maximization test
induction: 10 %
challenge: 10 %
rate: II
score: 0.1%
thymol was negative in the Draize test (DT) (individual scores not mentioned)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The endpoint 'Skin sensitisation' is waived based on the classification as Skin Corr. 1B (H314). As supporting information several studies are available. In these studies thymol was negative in the Open Epicutaneous Test (OET), the Draize Test (DT), the Maximisation Test (MT) and the Freund's Complete Adjuvant Test (FCAT) (Klecak 1977, Ishihara 1986). Also, from several patch tests in humans conducted in dermatological institutions (please refer to section 7.10.3), it can be concluded that the sensitising potential of thymol is very low.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the outcome of the skin sensitisation tests in animals and humans showing low sensitising potential of thymol, it is concluded that the substance does not need to be classified according to Regulation (EC) No 1272/2008 with regard to sensitisation.
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