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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 -14 November 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline No 405 with deviations: no data on purity; no certificate of analysis of the test substance; non-ocular local and systemic adverse effects were not followed.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on purity; no certificate of analysis of the test substance; non-ocular local and systemic adverse effects were not followed
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-mentha-1,4(8)-diene
- EC Number:
- 209-578-0
- EC Name:
- p-mentha-1,4(8)-diene
- Cas Number:
- 586-62-9
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexene
- Details on test material:
- Name of the test item (as cited in the study report): HR 00/660425
Chemical name: 1-methyl-4-(1-methylethyliden)-1-cyclohexen
Batch No.: 290600015
Colour: colourless to yellowish
Storage Conditions: in a cool and dry place
Expiry Date: 31 January 2000
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits of the stock New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Source: Charles River, Deutschland GmbH, Kißlegg, GERMANY
Weight: 2.0-2.1 kg
Housing: Housed individually in PPO cages with perforated floor
Diet: Pelleted complete rabbit diet "Altromin 2123" (Altromin, Lage, Germany), ad libitum
Water: Domestic quality drinking water (acidified with hydrochloric acid to pH 2.5), ad libitum
Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
Temperature: 20 ± 3 °C
Humidity: 55 ± 15 %
Air changes: 10/h
Photoperiod: 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.1 mL
Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Washing: after the first 24 h reading fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage.
SCORING SYSTEM: According to OECD Guideline 405
TOOL USED TO ASSESS SCORE: Eyes of the animals were examined with a hand held inspection lamp fitted with white and UV -light and magnifying glass with 2 X magnifications. The examination was performed before and after instillation of fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- At 1 h after application, all animals showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible and an obvious swelling with partial eversion of lids.
At 24 h after application, one animal showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible and a swelling above normal. Two animals showed some conjunctival vessels definitely injected and a swelling above normal. One animal showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, some conjunctival vessels definitely injected and a swelling above normal.
At 48 h after application, two animals showed some conjunctival vessels definitely injected and a swelling above normal. In one animal the conjunctiva was swollen above normal and the remaining animal was free of any signs of eye irritation.
At 72 h after application, two animals showed some conjunctival vessels definitely injected and a swelling above normal. The remaining two animals were free of any signs of eye irritation.
All the signs were resolved within 7 days after treatment. - Other effects:
- no data
Any other information on results incl. tables
Table 7.3.2/1: Scores for ocular lesions
Rabbit No. /weight (kg) |
Region of eye
|
Scores |
|||||
1 h |
24 h |
48 h |
72 h |
Day 7 |
Mean# |
||
1970 / 2.1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0.00 |
Iris |
1 |
0 |
0 |
0 |
0 |
0.00 |
|
Conjunctiva: redness |
2 |
2 |
1 |
1 |
0 |
1.33 |
|
Conjunctiva: chemosis |
2 |
1 |
1 |
1 |
0 |
1.00 |
|
1983 / 2.1 |
Cornea |
0 |
0 |
0 |
0 |
- |
0.00 |
Iris |
1 |
0 |
0 |
0 |
- |
0.00 |
|
Conjunctiva: redness |
2 |
1 |
0 |
0 |
- |
0.33 |
|
Conjunctiva: chemosis |
2 |
1 |
0 |
0 |
- |
0.33 |
|
1986 / 2.0 |
Cornea |
0 |
0 |
0 |
0 |
- |
0.00 |
Iris |
1 |
1 |
0 |
0 |
- |
0.33 |
|
Conjunctiva: redness |
2 |
1 |
0 |
0 |
- |
0.33 |
|
Conjunctiva: chemosis |
2 |
1 |
1 |
0 |
- |
0.67 |
|
1977 / 2.0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0.00 |
Iris |
1 |
0 |
0 |
0 |
0 |
0.00 |
|
Conjunctiva: redness |
2 |
1 |
1 |
1 |
0 |
1.00 |
|
Conjunctiva: chemosis |
2 |
1 |
1 |
1 |
0 |
1.00 |
#: Mean scores of 24, 48 and 72 h
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean scores obtained with terpinolene monoconstituent at 24, 48 and 72 h were 0.0 for cornea, 0.1 for iris, 0.7 for conjunctivae and 0.8 for chemosis, therefore terpinolene monoconstituent is not classified as irritating to the eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
- Executive summary:
In an eye irritation study conducted according to OECD Guideline No 405 and in compliance with GLP, 4 female SPF albino rabbits of the stock New Zealand White were exposed to 0.1 mL of undiluted terpinolene monocontituent in one eye, while other eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. At 24 h after treatment, fluorescein solution was instilled into the eyes, washed with 0.9 % sodium chloride solution and then eyes were examined using UV-light to detect possible corneal damage. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and 7 days after treatment and graded according to the method of OECD Guideline No 405.
At 1 h after instillation, all animals showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible and an obvious swelling with partial eversion of lids. At 24 h after application, one animal showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible and a swelling above normal. Two animals showed some conjunctival vessels definitely injected and a swelling above normal. One animal showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, some conjunctival vessels definitely injected and a swelling above normal. At 48 h after application, two animals showed some conjunctival vessels definitely injected and a swelling above normal. In one animal the conjunctiva was swollen above normal and the remaining animal was free of any signs of eye irritation. At 72 h after application, two animals showed some conjunctival vessels definitely injected and a swelling above normal. The remaining two animals were free of any signs of eye irritation. All the signs were resolved within 7 days after treatment. The calculated mean scores for each individual lesions for all animals within three scoring times (24, 48 and 72 h) were as follows: 0.0 for cornea score; 0.1 for iris score; 0.7 for conjunctivae score and 0.8 for chemosis score.
Therefore, terpinolene monoconstituent is not classified as irritating to the eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
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