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EC number: 948-032-2 | CAS number: -
- 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
Several reliable studies and assessment reports from competent authorities are available for acute oral toxicity of the starting materials alpha-pinen, beta-pinene and limonene.
Terpene dimers is primarily a mixture of terpene dimer with no more than trace quantities of unreacted monomer. The raw materials alpha-pinene, beta-pinene and limonene react by cationic polymerisation.
The raw materials are:
(R)-p-mentha-1,8-diene (D-limonene): EC: 227-813-5; ratio: 1 ~ 50
Pin-2(3)-ene (racemic mixture) (alpha-pinene); EC: 201-291-9; ratio: 15 ~ 45
(-)-pin-2(10)-ene (beta-pinene); EC: 242-060-2; ratio: 1 ~ 50
The reaction products terpene dimers are dimeric species of reactants covalently coupled twice. In other words, these species are structurally similar, i.e. they contain the same repeating reactant.
Overall, it can be assumed that the change in physical properties from the starting monomeric materials to dimeric reaction products, results in a substance with significantly reduced hazardous properties caused by increasing molecular weight and hence reduced bio-availability.
Therefore read-across from the starting materials to terpene dimers is fully justified.
Alpha- and beta-pinene and limonene as starting materials are of low acute oral toxicity. Therefore it can be concluded that the read-across target substance terpene dimers also exhibit low acute oral toxicity.
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:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reliable safety assessment of the European Food and Safety Authority (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF))
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not stated
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 700 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of alpha-pinene was estimated in male and female rats. Since the LD50 was found to be 3700 mg/kg body weight it can be assumed that alpha-pinene is of low acute oral toxicity.
- Executive summary:
The acute oral LD50 of alpha-pinene was estimated in male and female rats. Since the LD50 was found to be 3700 mg/kg body weight it can be assumed that alpha-pinene is of low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Summary from the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA).
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not speciefeied
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 700 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value for alpha-pinene has been reported as 3700 mg/kg body weight.This value indicates that alpha-pinene exhibits low acute oral toxicity.
- Executive summary:
The oral LD50 value for alpha-pinene has been reported as 3700 mg/kg body weight.This value indicates that alpha-pinene exhibits low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reliable safety assessment of the European Food and Safety Authority (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF))
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not stated
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of beta-pinene was estimated in rats. Since the LD50 was found to be > 5000 mg/kg body weight it can be assumed that beta-pinene is of low acute oral toxicity.
- Executive summary:
The acute oral LD50 of beta-pinene was estimated in rats. Since the LD50 was found to be > 5000 mg/kg body weight it can be assumed that beta-pinene is of low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Summary from the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA).
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not speciefeied
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value for beta-pinene has been reported as > 5000 mg/kg body weight.This value indicates that beta-pinene exhibits low acute oral toxicity.
- Executive summary:
The oral LD50 value for beta-pinene has been reported as >5000 mg/kg body weight.This value indicates that beta-pinene exhibits low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment report from a highly reputed government agency. Collection of data.
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not stated
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An oral median lethal dose (LD50) value of > 5000 mg/kg Body weight is reported for beta-pinene.
- Executive summary:
An oral median lethal dose (LD50) value of > 5000 mg/kg Body weight is reported for beta-pinene
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reliable safety assessment of the European Food and Safety Authority (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF))
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not stated
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 700 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of limonene was estimated in male and female rats. Since the LD50 was found to be 3700 mg/kg body weight it can be assumed that limonene is of low acute oral toxicity.
- Executive summary:
The acute oral LD50 of limonene was estimated in male and female rats. Since the LD50 was found to be 3700 mg/kg body weight it can be assumed that limonene is of low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Summary from the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA).
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not speciefeied
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value for beta-pinene has been reported as > 5000 mg/kg body weight.This value indicates that beta-pinene exhibits low acute oral toxicity.
- Executive summary:
The oral LD50 value for limonene has been reported as >5000 mg/kg body weight.This value indicates that limonene exhibits low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Reliable Safety assessment of the MAK-Commission.
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 400 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 200 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of limonene was estimated in male and female rats. Since the LD50 was found to be 4400 mg/kg body weight in males and 5200 mg/kg body weight in females respectively it can be assumed that limonene is of low acute oral toxicity.
- Executive summary:
The acute oral LD50 of limonene was estimated in male and female rats. Since the LD50 was found to be 4400 mg/kg body weight in males and 5200 mg/kg body weight in females respectively it can be assumed that limonene is of low acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment report from a highly reputed government agency. Collection of data.
- GLP compliance:
- not specified
- Remarks:
- publication
- Test type:
- other: not stated
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An oral median lethal dose (LD50) value of > 5000 mg/kg body weight is reported for d-limonene.
- Executive summary:
An oral median lethal dose (LD50) value of > 5000 mg/kg body weight is reported for d-limonene.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Reliable data are available for the starting materials for terpenen dimers.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) classification and labelling is not required for acute oral toxicity of terpene dimers, based on reliable data from the read across source substances alpha-pinene, beta-pinene and limonene.
Alpha- and beta-pinene and limonene as starting materials are of low acute oral toxicity. Therefore it can be concluded that the read-across target substance terpene dimers is also exhibit low acute oral toxicity.
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.