Registration Dossier
Registration Dossier
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EC number: 948-406-5 | CAS number: -
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- April 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Jul 2016 version
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3a,4,7,7a-tetrahydro-1H-indene
- EC Number:
- 221-260-3
- EC Name:
- 3a,4,7,7a-tetrahydro-1H-indene
- Cas Number:
- 3048-65-5
- Molecular formula:
- C9H12
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-1H-indene
- Reference substance name:
- 4-vinylcyclohexene
- EC Number:
- 202-848-9
- EC Name:
- 4-vinylcyclohexene
- Cas Number:
- 100-40-3
- Molecular formula:
- C8H12
- IUPAC Name:
- 4-vinylcyclohexene
- Reference substance name:
- Cyclopentadiene
- EC Number:
- 208-835-4
- EC Name:
- Cyclopentadiene
- Cas Number:
- 542-92-7
- Molecular formula:
- C5H6
- IUPAC Name:
- cyclopenta-1,3-diene
- Reference substance name:
- cis-1,2-Divinylcyclobutane
- Cas Number:
- 2422-85-7
- Molecular formula:
- C8H12
- IUPAC Name:
- cis-1,2-Divinylcyclobutane
- Reference substance name:
- Ethylbenzene
- EC Number:
- 202-849-4
- EC Name:
- Ethylbenzene
- Cas Number:
- 100-41-4
- Molecular formula:
- C8H10
- IUPAC Name:
- ethylbenzene
- Reference substance name:
- 5-vinylnorborn-2-ene
- EC Number:
- 221-259-8
- EC Name:
- 5-vinylnorborn-2-ene
- Cas Number:
- 3048-64-4
- Molecular formula:
- C9H12
- IUPAC Name:
- 5-vinylbicyclo[2.2.1]hept-2-ene
- Reference substance name:
- Cycloocta-1,5-diene
- EC Number:
- 203-907-1
- EC Name:
- Cycloocta-1,5-diene
- Cas Number:
- 111-78-4
- Molecular formula:
- C8H12
- IUPAC Name:
- cycloocta-1,5-diene
- Reference substance name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- EC Number:
- 201-052-9
- EC Name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- Cas Number:
- 77-73-6
- Molecular formula:
- C10H12
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene,
- Reference substance name:
- 3a,4,7,7a-tetrahydro-4-methyl-1H-indene
- EC Number:
- 231-021-5
- EC Name:
- 3a,4,7,7a-tetrahydro-4-methyl-1H-indene
- Cas Number:
- 7413-02-7
- Molecular formula:
- C10H14
- IUPAC Name:
- 4-methyl-3a,4,7,7a-tetrahydro-1H-indene
- Reference substance name:
- Combination of: 6-(cyclohex-3-en-1-yl)bicyclo[2.2.1]hept-2-ene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4-methanonaphthalene 6-vinyl-1,4,4a,5,6,7,8,8a-octahydro-1,4-methanonaphthalene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene 2,2'-bi(bicyclo[2.2.1]heptane-5,5'-diene) 3a,4,4a,5,8,8a,9,9a-octahydro-1H-5,8-methanocyclopenta[b]naphthalene 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene
- Molecular formula:
- C13H18 to C14H18
- IUPAC Name:
- Combination of: 6-(cyclohex-3-en-1-yl)bicyclo[2.2.1]hept-2-ene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4-methanonaphthalene 6-vinyl-1,4,4a,5,6,7,8,8a-octahydro-1,4-methanonaphthalene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene 2,2'-bi(bicyclo[2.2.1]heptane-5,5'-diene) 3a,4,4a,5,8,8a,9,9a-octahydro-1H-5,8-methanocyclopenta[b]naphthalene 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene
- Reference substance name:
- 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene OR 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4:5,8-dimethanofluorene
- Molecular formula:
- C14H18 to C15H18
- IUPAC Name:
- 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene OR 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4:5,8-dimethanofluorene
- Reference substance name:
- 3a,4,4a,5,8,8a,9,9a-octahydro-4,9:5,8-dimethano-1H-benz[f]indene
- EC Number:
- 230-512-1
- EC Name:
- 3a,4,4a,5,8,8a,9,9a-octahydro-4,9:5,8-dimethano-1H-benz[f]indene
- Cas Number:
- 7158-25-0
- Molecular formula:
- C15H18
- IUPAC Name:
- 3a,4,4a,5,8,8a,9,9a-octahydro-1H-4,9:5,8-dimethanocyclopenta[b]naphthalene
- Reference substance name:
- Tetramers of cyclopentadiene and 1,3-butadiene
- Molecular formula:
- C16H24 to C20H24
- IUPAC Name:
- Tetramers of cyclopentadiene and 1,3-butadiene
- Test material form:
- liquid
- Details on test material:
- Light brown liquid.
Batch number 776809
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
impurity 1
Constituent 10
Constituent 11
Constituent 12
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epithelial
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epiderm
- Tissue batch number(s): 28691
- Assay medium lot number: 040419MSC
- Delivery date: 9/4/19
- Date of initiation of testing: 10/4/19
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Pre-incubation for 1hr at 37C (5% CO2)
- Temperature of post-treatment incubation (if applicable): 7C (5% CO2)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: each tissue well rinsed with continuous stream of Dulbecco's phosphate bufffered saline for 40 seconds.
- Modifications to validated SOP: none required
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 hr
- Spectrophotometer: Labtech LT-2500 microplate reader
- Wavelength: 580nm
- Filter bandwidth: 10nm
NUMBER OF REPLICATE TISSUES: duplicate
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues (if applicable): freezing
- N. of replicates : 2
- Method of calculation used: not required
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.] The corrosivity potential of the test item is predicted from the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL
VEHICLE
- None
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution): 8N - Duration of treatment / exposure:
- 3 mins and 60 mins
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- #1
- Value:
- ca. 92
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- #2
- Value:
- ca. 89.5
- 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:
- - OTHER EFFECTS:
- Visible damage on test system:
- Direct-MTT reduction:
- Colour interference with MTT:
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: viability 100%. Mean OD570 1.867 for 3 minute exposure and 1.933 for 60min exposure.
- Acceptance criteria met for positive control: 3min viability 3.7% and OD570 0.07 and 60min viabilty 3.5% and OD570 0.068.
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: no information available in study report.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a guideline and GLP in vitro skin corrosivity study using the reconstructed human epidermis (EPIDERM) technique, the substance THI-TM was found to be non-corrosive. Classification is therefore not required for this end point.
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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