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EC number: 242-361-9 | CAS number: 18479-57-7
- 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
Acute oral toxicity (OECDTG401): >5000 mg/kg bw
Acute dermal toxicity (OECDTG402): >5000 mg/kg bw
Acute inhalation toxicity using route to route extrapolation from the oral route: > 13000 mg/m3
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limit test with 10 males
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals (received on August 3, 1982)
- Weight at study initiation: 224-297 g
- Fasting period before study: 16-20 hours prior to dosing
- Housing: 5 animals per cage in suspended wire mesh cages.
- Diet (e.g. ad libitum): fresh Purina rat chow (Diet #5012) ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.81 mL
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed 3-4 hours post dosing and once daily after for 14 days for mortality, toxicity and pharmocological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: All animals suffered from flaccid muscle tone and lethargy, other signs observed in the animals were ataxia (9 animals), chromorhinorrhea (4), chromodacryorrhea (1), ptosis (1), brown staining of the anogenital area (3).
- Gross pathology:
- No abnormalities were found.
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria (1272/2008/EC and its updates)
- Conclusions:
- Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
- Executive summary:
An acute oral toxicity study was performed according to a method similar to OECD TG 401. In this study, 10 rats were administered Tetrahydromyrcenol at dose levels 5000 mg/kg bw. The mortality rate of the rats was 0/10. Clinical signs observed were flaccid muscle tone and lethargy, ataxia, chromorhinorrhea, chromodacryorrhea, ptosis and brown staining of the anogenital area. Gross necropsy was performed at end of term, but no abnormalities were found. Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- limit test with 9 females, 1 male
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals (received on July 27 and August 24, 1982)
- Weight at study initiation: 1.9-2.5 kg
- Housing: 2 animals per cage in suspended wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: abdomen
- % coverage: 10% of the body surface
- Type of wrap if used: gauze patch, wrapped wtih plastic, secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the site was wiped
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): between 11.6-14.0 ml
- Concentration (if solution): 0.82 g/ml
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 9 females, 1 male
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 hours post dose and on days 7 and 14 for mortality, toxicity and pharmacological effect.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: Dermal reactions (erythema and edema) were slight to moderate observed on day 1, severe on day 7, and minimal on dag 14. Physical signs observed were: Alopecia, diarrhea, few feces, yellow nasal discharge, ptosis.
- Gross pathology:
- No abnormalities were found on the internal organs on superficial examination for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted.
- Interpretation of results:
- other: not classified
- Remarks:
- according to EU CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
- Executive summary:
An acute dermal toxicity study was performed according to a method similar to OECD TG 402. In this study, 10 healthy albino rabbits were dosed dermally with Tetrahydromyrcenol at 5000 mg/kg bw of body weight. The test article was kept in contact with the skin for 24 hours. All rabbits survived the 5000 mg/kg bw dermal dose. Physical signs noted in 3 or more rabbits included yellow nasal discharge, diarrhea, alopecia and few feces. Dermal responses, slight to moderate on Day 1, were severe on Day 7 and minimal on Day 14. Body weight changes were normal for 7/10 rabbits. Three rabbits, exhibited diarrhea and/or few feces, lost weight. The internal organs on superficial examination appeared normal for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted. Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- comparable to guideline study with acceptable restrictions
Additional information
Acute oral toxicity
An acute oral toxicity study was performed according to a method similar to OECD TG 401. In this study, 10 rats were administered Tetrahydromyrcenol at dose levels 5000 mg/kg bw. The mortality rate of the rats was 0/10. Clinical signs observed were flaccid muscle tone and lethargy, ataxia, chromorhinorrhea, chromodacryorrhea, ptosis and brown staining of the anogenital area. Gross necropsy was performed at end of term, but no abnormalities were found. Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
Acute dermal toxicity
An acute dermal toxicity study was performed according to a method similar to OECD TG 402. In this study, 10 healthy albino rabbits were dosed dermally with Tetrahydromyrcenol at 5000 mg/kg bw of body weight. The test article was kept in contact with the skin for 24 hours. All rabbits survived the 5000 mg/kg bw dermal dose. Physical signs noted in 3 or more rabbits included yellow nasal discharge, diarrhea, alopecia and few feces. Dermal responses, slight to moderate on Day 1, were severe on Day 7 and minimal on Day 14. Body weight changes were normal for 7/10 rabbits. Three rabbits, exhibited diarrhea and/or few feces, lost weight. The internal organs on superficial examination appeared normal for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted. Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.
Acute inhalation toxicity: Acute inhalation is predicted based on the acute oral toxicity in accordance with the ECHA CLP guidance document (2015, 3.1.3.3.4: 1 mg/kg bw = 0.0052 mg/l (5.2 mg/m3). The acute inhalation is predicted to be > 13000 mg/m3 (using 100% inhalation and 50% oral absorption and an LD50 oral of > 5000 mg/kg bw). The calculated saturated vapour pressure is 604 mg/m3 (MW in mg*VP in Pa/ 8.3 (gas constant*293oK). This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation toxicity is anticipated.
Justification for classification or non-classification
Based on the available data, the substance does not need to be classified for acute oral, dermal and inhalation toxicity in accordance to EU CLP (1272/2008 and its amendments).
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