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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
Skin irritation
Key, OECD 404, rabbit, semiocclusive, skin corrosive
Eye irritation
Key, OECD 405, rabbit, eye
damage
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- MAR - AUG 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 MAY 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 19 SEP 1984
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd.
- Weight at study initiation: 3 - 3.4 kg
- Housing: single caged (type III cage)
- Diet (e.g. ad libitum): ad libitum (ssniff K 4, Versuchstierdiäten GmbH, Soest/Westfalen)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (+/- 2)
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened with water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): moistened patch - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 6 (4 males + 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: patch 'Hypoallergen' (Beiersdorf No. 2342), wrap 'Fixomull-Strech Klebevlies' (Beiersdorf No. 2039)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): exposed areas were washed with water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
24 h , 48 h, 72 h, 7 d, 14 d
SCORING SYSTEM:
- Method of calculation: Draize score - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- F85
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- F85
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- F85
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- G88
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- G88
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- G88
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- E91
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- E91
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- E91
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- E91
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- E91
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- E91
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- J3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- J3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- J4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- J4
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- J4
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- J4
- Time point:
- 24/48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- J4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- J5
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- J5
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- J5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- In rabbit E91 the application site was necrotic from the 1st day of observation and in rabbits F85 and G88 from the 2nd day of observation. In rabbit J3 there was a necrotic application site at the 1 h assessment time point; in rabbits J4 and J5 the application site was hardened at the 1 h assessment time point. In rabbits F85, G88, E91, J3, J4 and J5, these skin changes persisted until the end of the observation period.
Based on these results the test item is assessed as 'skin corrossive'. - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- EU GHS
- Conclusions:
- Based on the results of this study the test item is assessed as 'skin corrossive'.
- Executive summary:
The test item was tested ina study according to OECD TG 404. 500 mg of the test substance were applied for 4 h on the skin of six rabbits. The post observation time was 14 days. Erythrema and edema were observed in all animals. The findings were not reversible within 14 days. As a result, the test item was classified as corrosive.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- MAR - AUG 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 12 MAY 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 19 SEP 1984
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd.
- Weight at study initiation: 3.1 - 3.7 kg
- Housing: single caged (type III cage)
- Diet (e.g. ad libitum): ad libitum (ssniff K 4, Versuchstierdiäten GmbH, Soest/Westfalen)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (+/- 2)
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with physiological NaCl solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein, UV light - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- F84
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- F84
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- F84
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- F84
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- D87
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- D87
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- D87
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- D87
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- D86
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- D86
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- D86
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- D86
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritant / corrosive response data:
- A positive fluorescein test was shown up to the 21st day of follow-up. Rabbits D87 and D86 showed a pannus effect from the 14th day of follow-up. In rabbit D86 there was swelling in the lower area of the globe from the 14th day of observation.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- EU GHS
- Conclusions:
- Based on the results of this study the test item is assessed as 'irreversible effects on the eye', as the effects were irreversible in one out of three animals.
- Executive summary:
The test item was tested for eye irritation in a study according to OECD TG 405. Three rabbits received a dose of 100 µL/animal in the conjunctival sac of the eye. After 24 h the eye was washed. The eyes were examined for a postexposure period of 21 days. As a result, the test item induced eye damage, as the effects were irreversible in one out of three animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
An in vivo study in rabbits according to OECD TG 404 was performed (Ruf 1986). The following results were obtained:
-mean value of edema score (24, 48, 72 h) = 2.1
-mean value of erythema (24, 48, 72 h) = 2.1
-The findings were not reversible within 14 days
-> As a result, thymol is corrosive to the skin.
Eye irritation
An in vivo study in rabbits according to OECD TG 405 was performed (Ruf 1986). The following results were obtained:
-mean value of conjunctiva score (24, 48, 72 h) = 2.3 (mean value animal 1 -3)
-mean value of the cornea score (24, 48, 72 h) = 2 (mean value animal 1 -3)
-mean value of the iris score (24, 48, 72 h) = 1 (mean value animal 1 -3)
-mean value of the chemosis score (24, 48, 72 h) = 2.1 (mean value animal 1 -3)
-The findings were not reversible within 21 days in one animal
-> As a result, thymol induces eye damage.
Justification for classification or non-classification
Based on the result of the skin irritation/corrosion study a classification as Skin Corr. 1B (H314) according to Regulation (EC) No 1272/2008 is justified. Classification as Eye Dam. 1 (H318) is also triggered by the classification as Skin Corr. 1B.
This outcome also correlates with the harmonised CLP classification of thymol for irritation/corrosion (H314).
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