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EC number: 946-570-2 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- yes
- Remarks:
- minor deviations considered to have no impact on the conclusion of the study for more information see Details on study design
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 23 October 2015
Test material
- Reference substance name:
- Pin-2(3)-ene
- EC Number:
- 201-291-9
- EC Name:
- Pin-2(3)-ene
- Cas Number:
- 80-56-8
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Reference substance name:
- 2,2,6-trimethylcyclohexan-1-one
- EC Number:
- 219-309-9
- EC Name:
- 2,2,6-trimethylcyclohexan-1-one
- Cas Number:
- 2408-37-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 2,2,6-trimethylcyclohexanone
- Reference substance name:
- (1α,3α,5α)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- EC Number:
- 216-813-0
- EC Name:
- (1α,3α,5α)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- Cas Number:
- 1674-08-4
- Molecular formula:
- C10H16O
- IUPAC Name:
- 6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
- Reference substance name:
- Endo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- EC Number:
- 200-964-4
- EC Name:
- Endo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Cas Number:
- 76-49-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Reference substance name:
- [1aR-(1aα,7α,7aβ,7bα)]-1a,2,3,5,6,7,7a,7b-octahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulene
- EC Number:
- 244-565-3
- EC Name:
- [1aR-(1aα,7α,7aβ,7bα)]-1a,2,3,5,6,7,7a,7b-octahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulene
- Cas Number:
- 21747-46-6
- Molecular formula:
- C15H24
- IUPAC Name:
- (1aR,7R,7aS,7bR)-1,1,4,7-tetramethyl-1a,2,3,5,6,7,7a,7b-octahydro-1H-cyclopropa[e]azulene
- Reference substance name:
- 1aR,4R,4aS,7R,7aS,7bS)-1,1,4,7-tetramethyl-2,3,4a,5,6,7,7a,7b-octahydro-1aH-cyclopropa[e]azulen-4-ol
- Cas Number:
- 577-27-5
- Molecular formula:
- C15H26O
- IUPAC Name:
- 1aR,4R,4aS,7R,7aS,7bS)-1,1,4,7-tetramethyl-2,3,4a,5,6,7,7a,7b-octahydro-1aH-cyclopropa[e]azulen-4-ol
- Reference substance name:
- [1aR-(1aα,4β,4aβ,7α,7aβ,7bα)]-decahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulen-4-ol
- EC Number:
- 209-003-3
- EC Name:
- [1aR-(1aα,4β,4aβ,7α,7aβ,7bα)]-decahydro-1,1,4,7-tetramethyl-1H-cycloprop[e]azulen-4-ol
- Cas Number:
- 552-02-3
- Molecular formula:
- C15H26O
- IUPAC Name:
- (1aR,4S,4aS,7R,7aS,7bS)-1,1,4,7-tetramethyl-2,3,4a,5,6,7,7a,7b-octahydro-1aH-cyclopropa[e]azulen-4-ol
- Test material form:
- liquid
- Details on test material:
- Name Cistus Organic Oil
Batch no. 1215/2
CAS No. 89997-74-0
EINECS-No. 289-711-7
Purity 100%wt (UVCB substance)
Appearance: orange-yellow mobile liquid
Production date 23. Dec. 2015
Expiry date 22. Dec. 2017
Storage: Room Temperature (20 ± 5°C)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Test animals / tissue source
- Species:
- human
- Strain:
- other: reconstructed human Cornea-like Epithelium
- Details on test animals or tissues and environmental conditions:
- EpiOcular TM tissue Model OCL-212 supplied by MatTek
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test item was applied as supplied at the dose of 50 µl
- Duration of treatment / exposure:
- 29 minutes
- Duration of post- treatment incubation (in vitro):
- A 12 -minute post exposure immersion period at room temperature and 2 hours and 5 minutes post exposure incubation at standard culture conditions.
- Number of animals or in vitro replicates:
- 4 replicates.
- Details on study design:
- Deviations from the study plan:
- Incubator temperature: The temperature in the incubator reached 38.4°C which is +0.4°C higher than the 37+/-1°C as initially scheduled ==> Considering the results obtained, this deviation is considered to have no impact on the conclusion of the study
- Test system: RhCE tissue used was OCL-212 instead of OCL-200 ==> This reference corresponds to a 12-tissue kit whereas OCL-200 refers to individual tissues or 24-tissue kit. ==> This deviation is considered to have no impact on the conclusion of the study
- Treatment of the results: the true viability % of the tissues treated with the test item was calculated by subtracting the mean viability percents of the test item and the NSC living control instead of their ODs as scheduled in the study plan ==> This deviation is considered to have no impact on the conclusion of the study.
- In the first run, the mean tissue viability of the tissues treated with the positive control substance was slightly > 50% (50.58%), instead of <50% as initially scheduled in the study plan. ==> Considering the results obtained, this deviation is considered as without impact on the conclusion of the study.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: mean percent tissue viability
- Run / experiment:
- first run
- Value:
- 63.14
- Negative controls validity:
- valid
- Positive controls validity:
- not valid
- Remarks:
- percent tissue viability = 50.58%
- Irritation parameter:
- other: mean percent tissue viability
- Run / experiment:
- Second run
- Value:
- 48.72
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- mean percent tissue viability : 40.30%
In vivo
- Irritant / corrosive response data:
- Cistus oil is potentially irritating or corrosive to the eye.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- other: other experiment to class in category 1 or 2 need to be performed
- Conclusions:
- Cistus oil is potentially irritating or corrosive to the eye. It has to be identified as potentially requiring classification and labelling according to UN GHS category 2 or category 1.
- Executive summary:
In a GLP study according to OECD 492 guideline the irritant and corrosive potential of Cistus oil was evaluated. The method is based on viability of Reconstructed Human Cornea-like Epithelium-(RhCE) when exposed to the test substance. In a first run, the mean tissue viability of the tissues treated with the positive control substance was slightly > 50% (50.58%), instead of < 50%. The positive control was not validated therefore a second run was performed. The mean percent tissue viability of the RhCE replicates treated with the test item was 48.72% versus 40.30% in the positive control (Methyl acetate). In conclusion, under experimental conditions adopted and in accordance with the Regulation EC N° 1272/2008 the test item has to be identified as potentially requiring classification and labelling according to UN GHS category 2 or category 1.
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