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EC number: 933-779-9 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 may 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- yes
- Remarks:
- The deviations were considered not to adversely affect the results or integrity of the study
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin™ SOP, Version 1.8
- Deviations:
- yes
- Remarks:
- The deviations were considered not to adversely affect the results or integrity of the study
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin™(SM) SOP, INVITTOX Protocol No. 118
- Deviations:
- yes
- Remarks:
- The deviations were considered not to adversely affect the results or integrity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- The deviations were considered not to adversely affect the results or integrity of the study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (Z)-3,7-dimethylocta-1,3,6,-triene
- EC Number:
- 222-081-3
- EC Name:
- (Z)-3,7-dimethylocta-1,3,6,-triene
- Cas Number:
- 3338-55-4
- Molecular formula:
- C10H16
- IUPAC Name:
- 3,7-dimethylocta-1,3,6-triene
- Reference substance name:
- Dipentene
- EC Number:
- 205-341-0
- EC Name:
- Dipentene
- Cas Number:
- 138-86-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-methyl-4-(prop-1-en-2-yl)cyclohexene
- Reference substance name:
- 2,6-dimethylocta-2,4,6-triene
- EC Number:
- 211-614-5
- EC Name:
- 2,6-dimethylocta-2,4,6-triene
- Cas Number:
- 673-84-7
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6-dimethylocta-2,4,6-triene
- Reference substance name:
- (E)-3,7-dimethylocta-1,3,6-triene
- EC Number:
- 223-241-5
- EC Name:
- (E)-3,7-dimethylocta-1,3,6-triene
- Cas Number:
- 3779-61-1
- Molecular formula:
- C10H16
- IUPAC Name:
- 3,7-dimethylocta-1,3,6-triene
- Test material form:
- liquid
- Details on test material:
- Name: [Reaction mass of dipentene and (Z)-3,7-dimethylocta-1,3,6,-triene]
Public name: Ocimene PQ
EC numbers: 933-779-9 (pre-registration 222-081-3)
CAS numbers: n/a (pre-registration 3338-55-4)
Batch/Lot number: A170524D
Description: Colourless liquid
Expiry date: 06 June 2019
Purity: Considered as 100%
Constituent 1
Constituent 2
impurity 1
impurity 2
- Specific details on test material used for the study:
- - Test Item: Reaction mass of dipentene and (Z)-3,7-dimethylocta-1,3,6,-triene
- Public name: Ocimene PQ
- EC number: 933-779-9 (pre-registration 222-081-3)
- CAS number: n/a (pre-registration 3338-55-4)
- Batch/Lot number: A170524D
- Appearance: Colorless liquid
- Purity**: Considered as 100%
- Expiry date: 06 June 2019
- Storage conditions: Room temperature (15-25 °C, ≤ 70% relative humidity (RH)), under inert gas, protected from humidity (tightly closed container)
- Safety precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.
- Identification and Receipt: The test item of a suitable chemical purity was supplied by the Sponsor.
- Preparation of the Test Item: The test item was applied as supplied.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKINTM(SM) (Manufacturer: SkinEthic, France) - Tree-dimensional human epidermis model.
- Details on animal used as source of test system:
- TEST SYSTEM: EPISKINTM(SM) (Manufacturer: SkinEthic, France) is a three-dimensional human epidermis model. Adult humanderived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
A highly differentiated and stratified epidermis model is obtained after 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. - Justification for test system used:
- The EPISKINTM(SM) model has been validated for corrosivity and irritation testing in an international validation study and its use is recommended by the relevant OECD guidelines for corrosivity and irritation testing (OECD No. 431 and OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:
EPISKIN TM (SM) (Manufacturer: SkinEthic, France, Batch No.: 18-EKIN-022, Expiry Date: 04 June 2018)
- Units: EPISKIN TM (SM) plate containing up to 12 reconstructed epidermis units (area: 0.38 cm*2) each reconstructed epidermis is attached to the base of a tissue culture vessel with an O-ring set and maintained on nutritive agar for transport.
- Plate: 12-well assay plates
- Punch: EPISKIN TM (SM) biopsy punch for easy sampling of epidermis
- A flask of sterile “Assay Medium” (Batch No.: 18 ESSC 024; Exp. Date: 06 June 2018)
- Storage: The kits were kept in their packaging at 37 °C, the Assay Medium and Maintenance Medium supplied with the kits were stored at 2-8 °C until the initiation of the test.
MTT SOLUTION
MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1] was diluted in phosphate buffered saline (PBS) at a final concentration of 3 mg/mL (MTT stock solution). The obtained stock solutions were stored in refrigerator (2-8 °C) protected from light. These were diluted with pre-warmed (37°C) Assay Medium to a final concentration of 0.3 mg/mL (MTT working solution) immediately before use.
ACIDIFIED ISOPROPANOL
Isopropanol was acidified with HCl acid to achieve a final concentration of 0.04N HCl (1.8 mL of 12N HCl acid was diluted in 500 mL isopropanol, or similar ratio was applied). The solution was prepared on the day of use.
CHEMICALS USED IN THE EXPERIMENT:
- MTT
- Isopropanol
- Hydrochloric acid
- Phosphate buffered saline (PBS)
PREDICTION MODEL / DECISION CRITERIA
General validity criteria
- The mean OD value of the two or three negative control tissues should be ≥ 0.6 and ≤ 1.5.
- The mean OD value of the blank samples (acidified isopropanol) should be < 0.1.
Specific criteria for corrosivity
- The difference of viability between the two tissue replicates should not exceed 30%.
- The acceptable mean percentage viability range for positive controls is ≤ 20%. - Control samples:
- other: Positive controls: Glacial acetic Negative controls: Physiological saline (0.9% (w/v) NaCl solution)
- Amount/concentration applied:
- TEST MATERIAL
The Maintenance Medium was pre-warmed to 37°C. The appropriate number of wells in an assay plate was filled with the pre-warmed medium (2 mL per well). The epidermis units were placed with the media below them, whereby each epidermis was in contact with the medium in the corresponding well underneath.
50 µL of test item was applied evenly to each of two test units and each additional control skin units.
NEGATIVE AND POSITIVE CONTROLS
50 µL of negative control (Physiological saline) or positive control (glacial acetic acid) were added to each skin unit - Duration of treatment / exposure:
- The plates with the treated epidermis units were incubated for the exposure time of 4 hours (± 10 min) at room temperature (23.0-24.2°C) in the corrosivity test.
- Number of replicates:
- TEST ITEM TEST AND CONTROLS:
- Two replicates per time point were used for test item
- Two negative controls and two positive controls
- Two additional test item-treated living tissues were used for the non-specific OD evaluation
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 77
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of skin corrosion
- Remarks:
- Mean experiments 1,2: 76.0%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 75
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of skin corrosion
- Remarks:
- Mean experiments 1,2: 76.0%
- Other effects / acceptance of results:
- VALIDITY OF THE TEST
General validity criteria:
- After receipt, the two indicators of the delivered kits were in proper conditions.
- The mean OD value of the two negative control tissues in the corrosivity and irritation test was in the recommended range (0.954 and 0.723).
- The mean OD value of the blank samples (acidified isopropanol) was 0.047 in both cases.
Specific criteria for corrosivity testing:
- The two positive control treated tissues showed 0.5% viability demonstrating the proper performance of the assay.
- The difference of viability between the two test item-treated tissue samples in the MTT assay was 2.7%.
- The difference of viability between the two negative control tissue samples in the MTT assay was 1.3%.
All these parameters were within acceptable limits and therefore the study was considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The resuts of this study indicated that test material Reaction mass of dipentene and (Z)-3,7-dimethylocta-1,3,6,-triene (Batch number: A170524D), is non-corrosive to the skin.
- Executive summary:
The aim of this study was to evaluate the corrosion to skin potential of the test material Ocimene P - Reaction mass of dipentene and (Z)-3,7-dimethylocta-1,3,6,-triene EC Number 933-779-9 using reconstructed the human epidermis model EPISKINTM(SM). The study was performed according to the OECD 431 Guideline and under GLP conditions.
Disks of EPISKINTM(SM) were treated with the test item and incubated 4 hours at room temperature.
Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS).
The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in an incubator with 5% CO2 protected from light, in a > 95% humidified atmosphere.
Physiological saline (0.9% (w/v) NaCl solution) treated epidermis were used as negative control and glacial acetic acid treated epidermis were used as positive control (two units/control)
The result of this study showed that, following exposure with Reaction mass of dipentene and (Z)-3,7-dimethylocta-1,3,6,triene (Ocimene PQ), the mean cell viability was 76.0% compared to the negative control.
This value is above the threshold of 35%, therefore the test item was considered non- corrosive to skin. The validity criteria were met and the study was considered to be valid.
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