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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
Key, rat, 19 weeks, feeding study, NOAEL (systemic) = 10000 ppm thymol in the diet (= ca. 667 mg/kg bw/day) (Hagan, 1967)
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 5 male and 5 female rats per group were fed 1000, 10000 ppm thymol in the diet (= ca. 67, 667 mg/kg bw/day) for 19 weeks.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- Commercially-available materials, rather than pure chemicals, were used since the purpose of these studies was to evaluate the toxicity of these materials in relation to their use as food additives.
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: weanling
- Housing: individually in wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 19 weeks
- Frequency of treatment:
- daily via food
- Dose / conc.:
- 1 000 ppm
- Remarks:
- 1000 ppm nominal in diet (= ca. 67 mg/kg bw/day)
- Dose / conc.:
- 10 000 ppm
- Remarks:
- 10000 ppm nominal in diet (= 667 mg/kg bw/day)
- No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- yes, plain diet
- Details on study design:
- Rationale for animal assignment (if not random):
litter mates were used for the study
Post-exposure period: no - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: weekly
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 3, 6, 12 and 22 months
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- Parameters checked examined: red cell counts, white cell counts, haemoglobins, haematocrits
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Details on results:
- 10000 ppm (667 mg/kg bw/d): no effect on growth or haematology, and no macroscopic or microscopic change in the tissues
1000 ppm ( 67 mg/kg bw/d): no macroscopic effect, thus histopathology not performed - Dose descriptor:
- NOAEL
- Effect level:
- > 667 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- haematology
- histopathology: neoplastic
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- no
- Conclusions:
- The NOAEL was 10000 ppm (ca. 667 mg/kg bw/d); there was no effect on growth orhaematology, and no macroscopic or microscopic change in the tissues.
- Executive summary:
5 male and 5 female rats per group were fed 1000, 10000 ppm thymol in the diet (= ca. 67, 667 mg/kg bw/day) for 19 weeks. The rat's weight, food intake and general condition were recorded every week. Haematological examinations were made after 3, 6, 12 and 22 months. At the termination of the experiments the rats were sacrificed and exsanguinated. The tissues of all rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart and testes were weighed. These organs, the remaining abdominal and thoraic viscera, and one hind leg (for the examination of bone, bone marrow and muscle), were preserved in 10% buffered formalin-saline solution for histopathological examination. The NOAEL was 10000 ppm (ca. 667 mg/kg bw/d); there was no effect on growth or haematology, and no macroscopic or microscopic change in the tissues.
Reference
At the dose of 10000 ppm (667 mg/kg bw/d) there was no effect on growth or haematology, and no macroscopic or microscopic change in the tissues.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 667 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the repeated dose feeding study for 19 weeks no effects (indicates that there was no effect on growth or hematology, and no macroscopic or microscopic change is the tissue) at the highest applied dose (10000 ppm = 667 mg/kg bw/d) were seen (Hagan, 1967).
The gavage study (combined Repeat dose and Reproductive/Developmental toxicity screening test) (MHW Japan, 1996) revealed local effects with 40 mg/kg bw/d on the forestomach due to the corrosive properties of thymol, which were not seen in the 19 weeks oral feed study, where the test substance is incorporated in the feed matrix. Therefore for systemic effects the oral feed study was used and for local effects the gavage study, respectively.
Justification for classification or non-classification
Based on the available studies on repeated dose toxicity, it is concluded that the substance does not need to be classified according to Regulation (EC) No 1272/2008 for this hazard.
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