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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Referenceopen allclose all

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.

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.