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EC number: 944-483-4 | 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
TERPINOLENE MONOCONSTITUENT, one of the main constituent of the registered substance, is classifed as skin senitiser 1B. Therefore, according to the rules of classification criteria of Regulation (EC) No 1272/2008 (CLP), REACTION MASS OF 2,2,6-TRIMETHYL-1-OXASPIRO[2.5]OCT-5-ENE AND 4-ISOPROPYLIDENE-1-METHYLCYCLOHEXENE is classified as skin sensitiser 1B.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- TERPINOLENE MONOCONSTITUENT (source substance) is one of the main constituents of the registered substance (target substance).
- Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- The threshold positive value of 3 for the SI was reached in the positive control group (SI = 8.94). The experiment was therefore considered valid.
- Parameter:
- SI
- Remarks on result:
- other: see table 7.4.1/1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table 7.4.1/1
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A dose-related increase in the SI was recorded at concentrations ≥ 2.5%, and the threshold positive value of 3 was exceeded at the concentration of 10%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity.
Therefore, terpinolene monoconstituent is classified as sensitising "R43: May cause sensitisation by skin contact" according to Directive 67/548/EEC and skin sensitiser Category 1B according to CLP Regulation (EC) No 1272/2008. - Executive summary:
In a local lymph node assay performed according to OECD guideline No 429 and in compliance with GLP, terpinolene monoconstituent in Acetone/Olive oil (4/1, v/v) was administered to CBA/J 9 weeks old mice.
In a preliminary study, dryness of the skin and/or eryhema was observed on days 3 and/or 6 in ears of 2 animals treated at 50% or 100%. A notable increase in ear thickness was recorded at the concentration of 100%, showing the irritant potential of the test item at this concentration, therefore the highest concentration retained for the main test was 50%.
In a main study, five treated groups of four animals received applications of 25 μL of terpinolene monoconstituent to the external surface of both ears at the concentrations of 2.5, 5, 10, 25, and 50% for 3 consecutive days.
The positive control used was α-hexylcinnamaldehyde which presented a stimulation index of 8.94. Therefore, the positive control gave acceptable positive results and the study can be considered as valid.
No clinical signs and no mortality were observed during the main test. No local reactions and no notable increase in ear thickness were observed at any of the concentrations. Stimulation index for 2.5, 5, 10, 25, and 50 % were 1.24, 2.14, 3.43, 14.44 and 20.51, respectively. The calculated effective concentration inducing a SI of 3 (EC3) was 8%.
A dose-related increase in the SI was recorded at concentrations ≥ 2.5%, and the threshold positive value of 3 was exceeded at the concentration of 10%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity.
Therefore, terpinolene monoconstituent is classified as sensitising "R43: May cause sensitisation by skin contact" according to Directive 67/548/EEC and skin sensitiser Category 1B according to CLP Regulation (EC) No 1272/2008.
Reference
Table 7.4.1/1: Results of skin sensitization
Treatment and concentrations |
No. of nodes per group |
dpm per group |
dpm per node |
Stimulation index (SI) |
Increase in ear thickness (% between Day 1 and Day 6) |
Irritation level |
EC3 value |
Vehicle |
8 |
2706 |
338.25 |
- |
-1.03 |
- |
- |
2.5 % |
8 |
3347 |
418.38 |
1.24 |
-1.00 |
I |
8 % |
5 % |
8 |
5781 |
722.63 |
2.14 |
5.15 |
I |
|
10 % |
8 |
9290 |
1161.25 |
3.43 |
2.04 |
I |
|
25 % |
8 |
39074 |
4884.25 |
14.44 |
1.01 |
I |
|
50 % |
8 |
55509 |
6938.63 |
20.51 |
10.00 |
II |
|
α-hexylcinnamaldehyde |
8 |
24195 |
3024.38 |
8.94 |
- |
- |
- |
dpm = disintegrations per minute
I = non-irritant (increase in ear thickness < 10 %)
II = slightly irritant (increase in ear thickness = 10 to 25 %)
EC3 value = theoretical concentration resulting in a SI value of 3
stimulation index = dpm of treated group / dpm of control group
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Data were available from scientific litterature about the sensitisation of TERPINOLENE MONOCONSTITUENT, one of the main contituents of the registered substance.
In a LLNA performed according to OECD 429 Guideline and in compliance with GLP, groups of CBA/J mice (4 females/dose) were exposed to 25 µL
of terpinolene monoconstituent in Acetone/Olive oil (4/1, v/v) at concentrations of 0 (vehicle control), 2.5, 5, 10, 25 and 50 % (v/v) to the dorsal surface of both ears for three consecutive days.
No clinical signs and no mortality were observed during the main test. No local reactions and no notable increase in ear thickness were observed at any of the tested concentrations. Stimulation Index for 2.5, 5, 10, 25, and 50 % were 1.24, 2.14, 3.43, 14.44 and 20.51, respectively. The calculated effective concentration inducing a SI of 3 (EC3) was 8 %. A dose-related increase in the SI was recorded at concentrations higher than 2.5%, and the threshold positive value of 3 was exceeded at the concentration of 10%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity. Therefore, terpinolene monoconstituent was considered as skin sensitising.
REACTION MASS OF 2,2,6-TRIMETHYL-1-OXASPIRO[2.5]OCT-5-ENE AND 4-ISOPROPYLIDENE-1-METHYLCYCLOHEXENE is classified as skin sensitiser 1B.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Data were available from scientific litterature about the sensitisation of TERPINOLENE MONOCONSTITUENT, one of the main contituents of the registered substance.
TERPINOLENE MONOCONSTITUENT one of the main constituent of the registered substance, is classifed as skin senitiser 1B because
positive response was indiced in a LLNA with an EC3 = 8%.
Therefore, according to the rules of classification criteria of Regulation (EC) No 1272/2008 (CLP), REACTION MASS OF 2,2,6-TRIMETHYL-1-OXASPIRO[2.5]OCT-5-ENE AND 4-ISOPROPYLIDENE-1-METHYLCYCLOHEXENE is classified as skin sensitiser 1B.
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