Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-578-0 | CAS number: 586-62-9
- 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
An oral diet repeated dose toxicity study (combined with a reproduction/developmental toxicity screening test) was conducted with terpinolene monoconstituent according to OECD Guideline No 422 and in compliance with GLP.
The NOAEL (No Observed Adverse Effect Level) for systemic toxicity was determined to be 2500 ppm for females (equivalent to 161.5 mg/kg bw/day) and 5000 ppm for males (equivalent to 294.6 mg/kg bw/day). A combined NOAEL for males and females was determined as 154.6 mg/kg bw/day and was used for risk assessment.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 154.6 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Recent GLP study conducted according to OECD Guideline No 422 without any deviation (Klimisch score = 1).
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 a combined repeated dose toxicity study with a reproduction / developmental toxicity screening test conducted according to OECD 422 Guideline and in compliance with GLP, terpinolene monoconstituent was administered by dietary admixture (initially mixed with 2 % corn oil to avoid evaporation) to three groups of Sprague-Dawley rats, for 42 consecutive days, at dietary concentrations of 0, 800, 2500 and 5000 ppm (equivalent to a mean achieved dosage of 0, 54.1, 154.6 and 300.8 mg/kg bw/day, respectively). Animals allocated to the recovery phase assay were treated for 42 days and then given untreated diet (with 2% corn oil) for a further 14 days.
No unscheduled deaths or treatment-related clinical signs were noted. No treatment-related effects were noted on behavioural, sensory reactivity and functional performance parameters.
Reduced overall body weight gain was evident in animals of either sex treated with 5000 ppm (-24% in males, -50% in females). Males treated with 2500 ppm and females treated with 800 ppm showed a reduction in body weight gain during the first week of treatment (-22% and -28% respectively). No such effects were detected in males treated with 800 ppm.
Food consumption was adversely affected at 5000 ppm in animals of either sex and in toxicity and recovery phase females during the first week of treatment. It was considered to reflect a reluctance to eat the diet admixture due to its low palatability. Toxicity and recovery phase females also showed a reduction in dietary intake during the treatment period.
Water consumption was considered to have been unaffected by treatment.
Main phase males treated with 5000 ppm showed an increase in liver weight both absolute and relative to terminal body weight when compared to controls. Recovery 5000 ppm males continued to show an increase in absolute and relative liver weight following fourteen days without treatment. In liver, minimal to slight centrilobular hepatocellular hypertrophy was evident in main phase males treated with 2500 and 5000 ppm. The hepatocellular hypertrophy was partly reversible in severity following fourteen days without treatment however it was still at a minimal severity in all recovery males treated with 5000 ppm. Hepatocyte enlargement is commonly observed in the rodent liver following the administration of xenobiotics and in the absence of associated inflammatory or degenerative changes, is generally considered to be adaptive in nature and does not represent an adverse health effect.
Microscopic examination also revealed effects in the kidneys of males from all treatment groups. Minimal to marked multifocal tubular degeneration/regeneration was present in males from all treated groups. These tubular findings were also accompanied by the presence of slight to marked hyaline droplets in the proximal convoluted tubules and minimal to moderate granular casts in the tubules of the inner cortex. Recovery 5000 ppm males showed minimal to slight multifocal tubular degeneration/regeneration in the renal cortical tubules and minimal to slight hyaline droplets were present in the proximal convoluted tubules. Minimal to moderate granular casts were also present in the tubules of the inner cortex. This finding is commonly observed in male rats following treatment with some xenobiotics and is not predictive of any adverse effect in humans.
No toxicologically significant effects were detected in any treated toxicity phase female or in main phase males treated with 800 or 2500 ppm.
No treatment-related significant changes were detected after haematology and blood chemistry investigations.
No toxicologically significant macroscopic abnormalities were detected in animals of either sex treated with 5000, 2500 or 800 ppm.
Under the test conditions, the No-Observed-Adverse-Effect-Level (NOAEL) of terpinolene monoconstituent for systemic toxicity for females and males was 2500 and 5000 ppm, respectively (equivalent to 161.5 mg/kg bw/day and 294.6 mg/kg bw/day respectively).
As no specific target organ toxicity relevant to humans was identified, it is not deemed necessary to perform a 90-day toxicity study.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available
Justification for classification or non-classification
No toxic effects were observed in the repeated dose toxicity study below 300.8 mg/kg bw/day (dose level >300 mg/kg bw/day). The major toxic effect observed at this dose level was a reduction in bodyweight gain, no target organ was identified. Therefore terpinolene monoconstituent is not classified for repeated dose toxicity according to Directive 67/548/EEC and CLP 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.