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EC number: 944-536-1 | 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 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS
- Version / remarks:
- 3rd revision
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(3aS*,4R*,5S*,7R*,7aS*)-4,7-methano-2,3,3a,4,5,6,7,7a-octahydro-1H-inden-5-yl]methyl acetate
- Molecular formula:
- C13H20O2
- IUPAC Name:
- [(3aS*,4R*,5S*,7R*,7aS*)-4,7-methano-2,3,3a,4,5,6,7,7a-octahydro-1H-inden-5-yl]methyl acetate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200 SIT Kit
- Tissue batch number(s): 23314
- Production date: Not reported
- Shipping date: Not reported
- Delivery date: 16 February 2016
- Date of initiation of testing: Pre-incubation phase started 16 February 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 ºC
- Temperature of post-treatment incubation (if applicable): 37 ± 1 ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 300 μL, one washing step
- Observable damage in the tissue due to washing: None reported
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Not applicable, microplate reader
- Wavelength: 570 ± 1 nm
- Filter: Not reported
- Filter bandwidth: 570 ± 1 nm
- Linear OD range of spectrophotometer: Not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Positive control; 4.77 %
- Barrier function: Not reported
- Morphology: Not reported
- Contamination: None reported
- Reproducibility: Relative standard deviation for mean viability; 14.79 % postive control. Relative standard deviation for mean absorption; 16.6 % postive control, 8.55 % negative control.
NUMBER OF REPLICATE TISSUES: 3 per control and test item treatment
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues Not applicable
- Procedure used to prepare the killed tissues (if applicable): Not applicable
- N. of replicates : Not applicable
- Method of calculation used: Not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 43.5 hours exposure is less than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL
- Concentration (if solution): Undiluted test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution): Not reported
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL
- Concentration (if solution): 5 % SLS in deioinsied water; concentration not reported - Duration of treatment / exposure:
- 43.5 hours
- Duration of post-treatment incubation (if applicable):
- 67.5 hours
- Number of replicates:
- 3 per test item, negative control or postive control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Tissue 1
- Value:
- 0.601
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Tissue 2
- Value:
- 0.592
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Tissue 3
- Value:
- 0.585
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Mean absorbance of three wells blank corrected
- Run / experiment:
- Mean
- Value:
- 0.593
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Tissue 1
- Value:
- 38.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Tissue 2
- Value:
- 37.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Tissue 3
- Value:
- 37.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: Relative absorbance (%) compared to blank
- Run / experiment:
- Mean
- Value:
- 37.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Standard deviation: 1.4 %
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: Did not show blue colour after 1 hour incubation
- Colour interference with MTT: No colour change
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, within the required range of OD ≥ 0.8 and ≤ 2.8
- Acceptance criteria met for positive control: Yes, induced a decrease in absorbance of 5.1 % compared to the negative control
Any other information on results incl. tables
Results of treatment with test item and the controls
Dose Group | Exposure Interval | Tissue No. | Absorbance 570 nm (Well 1) | Absorbance 570 nm (Well 2) | Absorbance 570 nm (Well 3) | Mean Absorbance of 3 Wells* | Mean Absorbance of three wells blank corrected | Mean Absorbance of three tissues after blank correction | Rel. Absorbance (%) 1, 2 + 3** | Relative Standard Deviation (%) | Mean. Rel. Absorbance (% of negative control)*** |
Blank | 0.037 | 0.038 | 0.038 | 0.038 | 0.000 | ||||||
Negative Control | 60 mins | 1 | 1.540 | 1.548 | 1.508 | 1.532 | 1.495 | 1.563 | 95.6 | 4.1 | 100.0 |
2 | 1.644 | 1.591 | 1.593 | 1.609 | 1.572 | 100.6 | |||||
3 | 1.717 | 1.631 | 1.630 | 1.659 | 1.622 | 103.8 | |||||
Positive Control | 60 mins | 1 | 0.117 | 0.120 | 0.118 | 0.118 | 0.081 | 0.080 | 5.2 | 4.4 | 5.1 |
2 | 0.118 | 0.107 | 0.116 | 0.113 | 0.076 | 4.8 | |||||
3 | 0.104 | 0.132 | 0.124 | 0.120 | 0.083 | 5.3 | |||||
Test item | 60 mins | 1 | 0.646 | 0.628 | 0.643 | 0.639 | 0.601 |
0.593 |
38.5 |
1.4 |
37.9 |
2 |
0.617 |
0.645 |
0.627 |
0.629 |
0.592 |
37.9 |
|||||
3 |
0.613 |
0.625 |
0.630 |
0.623 |
0.585 |
37.4 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue (rounded values): 100*(absorbancetissue)/ (mean absorbancenegative control)
***relative absorbance per treatment group (rounded values): 100*(mean absorbancetest item/positive control)/ (mean absorbancenegative control)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- and EU CLP criteria
- Conclusions:
- The test item is a category 2 irritant to skin according to UN GHS regulations based on a human skin model test conducted following OECD 439, EU B.46 and UN GHS guidelines and performed according to GLP.
- Executive summary:
The test item was assessed for skin irritation in a human skin model test conducted following OECD 439, EU B.46 and UN GHS guidelines in undiluted form alongside a postive and negative control. The results of the test indicate that the test item is a Category 2 irritant to skin according to the UN GHS regulations.
The study is a GLP compliant guideline experiment study available as an unpublished study report. The study has no restrictions and is fully adequate for assessment.
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.
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