Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 273-868-3 | CAS number: 69103-01-1
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-menth-1-en-8-yl acetate
- EC Number:
- 201-265-7
- EC Name:
- p-menth-1-en-8-yl acetate
- Cas Number:
- 80-26-2
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate
- Reference substance name:
- Myrcenyl acetate
- EC Number:
- 214-262-0
- EC Name:
- Myrcenyl acetate
- Cas Number:
- 1118-39-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,1-dimethyl-5-methylenehept-6-en-1-yl acetate
- Reference substance name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-183-1
- EC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-04-5
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-184-7
- EC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-05-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- EC Number:
- 233-564-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- Cas Number:
- 10235-63-9
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexyl acetate
- Reference substance name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- EC Number:
- 208-546-3
- EC Name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- Cas Number:
- 532-87-6
- Molecular formula:
- C20H32
- IUPAC Name:
- 4-(5-methyl-1-methylenehex-4-en-1-yl)-1-(4-methylpent-3-en-1-yl)cyclohexene
- Reference substance name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- EC Number:
- 244-028-3
- EC Name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- Cas Number:
- 20777-47-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexyl acetate
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H16O
- IUPAC Name:
- 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
- Reference substance name:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Cas Number:
- 150461-96-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Reference substance name:
- Tentative monoterpene diacetate
- IUPAC Name:
- Tentative monoterpene diacetate
- Reference substance name:
- Tentative oxygenated monoterpene acetate
- IUPAC Name:
- Tentative oxygenated monoterpene acetate
- Reference substance name:
- Tentative Diterpene hydrocarbon
- IUPAC Name:
- Tentative Diterpene hydrocarbon
- Reference substance name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- IUPAC Name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
- Specific details on test material used for the study:
- Identification: Neobergamate Forte
Appearance: Pale yellow liquid
Batch: SC00015234
Purity/Composition: See Certificate of Analysis
Test item storage: At room temperature protected from light
Stable under storage conditions until: 07 November 2016 (expiry date)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 16-EKIN-005).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
Source
SkinEthic Laboratories, Lyon, France. - Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Application/Treatment of the test item
In the first test the standard deviation of the replicates treated with the test item was above acceptance criteria (not reported), therefore a repeat test was performed. The test was performed on a total of 3 tissues per test item together with negative and positive controls. Twenty five μl of the undiluted test item was added into 12-well plates on top of the skin tissues. Three tissues were treated with 25 μl PBS (negative control) and 3 tissues with 25 μl 5% SDS (positive control) respectively. The positive control was re-spread after 7 minutes contact time. After the exposure period of 15 ± 0.5 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test item. After rinsing, the cell culture inserts were each dried carefully and moved to a new well on 2 ml pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 hours at 37°C.
Cell viability measurement
After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 ml MTT-solution (0.3 mg/ml in PBS). The tissues were incubated for 3 h at 37°C. After incubation the tissues were placed on blotting paper to dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 μl isopropanol (Merck, Darmstadt, Germany). Tubes were stored refrigerated and protected from light for approximately 70 hours. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test item was classified according to remaining cell viability following exposure of the test item. - Amount/concentration applied:
- The liquid test item was applied undiluted (25 μl) directly on top of the tissue.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- > 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Acceptability of the assay
The in vitro skin irritation test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability should be ≤18.
b) The mean relative tissue viability of the positive control should be ≤50% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18.
c) The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18.
Data evaluation and statistical procedures
A test item is considered irritant in the skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
A test item is considered non-irritant in the in vitro skin irritation test if:
The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls.
Data interpretation of test items
Relative mean viability of 3 individual tissues after 15 minutes of exposure and 42 hours of post incubation - Prediction to be considered
≤ 50% of the mean viability of the negative controls - Category 1 or Category 2 (additional information on corrosion needed)
> 50% of the mean viability of the negative controls - No category
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It is concluded that this test is valid and that Neobergamate Forte is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.