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EC number: 261-118-8 | CAS number: 58096-47-2
- 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 / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan - March 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
- EC Number:
- 261-118-8
- EC Name:
- Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
- Cas Number:
- 58096-47-2
- Molecular formula:
- C16H26O2
- IUPAC Name:
- decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: Adult human-derived epidermal keratinocytes
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Source strain:
- not specified
- Justification for test system used:
- EPISKIN Standard Model™ is a 0.38 cm2 reconstituted human epidermis model. Adult human-derived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Procedure for application of test item (3 minutes treatment)
• 50 µL of the test item was applied evenly to the epidermal surface.
• Added 50 µL NaCl for negative control
• After application, plate containing the treated epidermis was closed with lid and incubated for 3 minutes at 37 °C and 5% CO2.
Procedure for application of test item (60 minutes treatment)
• 50 µL of the test item was applied evenly to the epidermal surface.
• Added 50 µL NaCl for negative control
• After application, plate containing the treated epidermis was closed with lid and incubated for 60 minutes at 37 °C and 5% CO2.
Procedure for application of test item (240 minutes treatment)
• 50 µL of the test item was applied evenly to the epidermal surface
• .Added 50 µL NaCl for negative control; 50 µL glacial acetic acid for positive control
• After application, plate containing the treated epidermis was closed with lid and incubated for 240 minutes at 37 °C and 5% CO2.
Approximately 1 minute interval between each tissue application was followed for all the time points of application - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- 50 µL NaCl
- Duration of treatment / exposure:
- 3 minutes, 60 minutes and 240 minutes exposure
- Duration of post-treatment incubation (if applicable):
- Incubated for 3, 60 and 240 minutes at 37 °C and 5% CO2.
- Number of replicates:
- Two
Test animals
- Species:
- other: Reconstituted Human epidermis (RHE)
- Strain:
- not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3,60 and 240 minutes
- Value:
- > 35
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table: Percent tissue viability
% Viability |
|||||||
3 minutes application |
60 minutes application |
240 minutes application |
|||||
Replicate |
NC |
Test item |
NC |
Test item |
NC |
PC |
Test item |
Rep 1 |
96.082 |
90.231 |
106.941 |
99.510 |
110.003 |
2.131 |
98.522 |
Rep 2 |
103.918 |
83.821 |
93.059 |
85.397 |
89.997 |
8.250 |
98.041 |
Mean |
100.0 |
87.03 |
100.0 |
92.45 |
100.0 |
5.19 |
98.28 |
SD |
5.540 |
4.533 |
9.816 |
9.979 |
14.147 |
4.327 |
0.340 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, the % viability of the test item DECAHYDRO-1, 1, 7-TRIMETHYL-3A, 7-METHANO-3AH-CYCLOPENTACYCLOOCT-3-YL FORMATE was greater than 35% of the negative control. Hence under the conditions of the study the test item was found to be ‘Non-corrosive’ to skin in accordance with UN GHS as specified in the OECD Guideline for the Testing of Chemicals.
- Executive summary:
Test item, Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate was applied topically to the EPISKINTMepidermal model (two epidermis units were used per each test item and negative controls) for three exposure periods viz., 3 minutes, 60 minutes and 240 minutes, additionally two epidermis units were used for positive control for the exposure period of 240 minutes. Exposure to the test item was terminated by rinsing with Dulbecco’s phosphate buffered saline (DPBS). The viability was assessed by incubating the tissues for 3 hours with MTT solution in a 12 well plate (0.3 mg/ml in assay medium; 2 ml per well). The precipitated formazan was then extracted using acidified isopropanol (0.5 ml) for 4 hours at room temperature and quantified spectrophotometrically at 560 nm using 96 well plates (200 μl/well).
Glacial acetic acid and Sodium chloride (9.0 g/ L) treated epidermis were used as positive (PC) and negative controls (NC) respectively. For each treated tissue, the viability was expressed as the % of the negative control tissues (mean).
3 minutes application:
The negative controls mean OD was found to be 0.983, which is well within the acceptability range (0.6 to 1.5). The variation within the replicates of negative control and test item was found to be lesser than 30%. The % viability of the test item was 87.03% and it was greater than 35% of the negative control. Hence no corrosive reaction observed with test item at 3 minutes application period.
60 minutes application:
The negative controls mean OD was found to be 0.868, which is well within the acceptability range (0.6 to 1.5). The variation within the replicates of negative control and test item was found to be lesser than 30%. The % viability of the test item was 92.45 % and it was greater than 35% of the negative control. Hence no corrosive reaction observed with test item at 60 minutes application period
240 minutes application:
The negative controls mean OD was found to be 0.727, which is well within the acceptability range (0.6 to 1.5). The variation within the replicates of negative control and test item was found to be lesser than 30%. The % viability of the test item was 98.28% and it was greater than 35% of the negative control. Hence no corrosive reaction observed with test item at 240 minutes application period.
The % viability of the positive control was, 5.191 % at 240 minutes application time and it was lesser than 50% of the respective negative controls, which reflects the corrosive nature of positive control and the sensitivity of the tissues used in the study.
The % viability of test item at the application periods of 3 minutes, 60 minutes and 240 minutes showed greater than 35% mean tissue viability in terms of % negative control. Hence the test item is not categorized as corrosive 1A, 1B and 1C.
The % viability of test item at the application period of 240 minutes showed greater than 35% mean tissue viability in terms of % negative control. Hence the test item is categorized as‘Non-corrosive’
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