Registration Dossier
Registration Dossier
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EC number: 948-406-5 | CAS number: -
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Jul 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- version Oct 2017
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- 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
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Adult cattle from local abattoir
- Number of animals: not specified
- Characteristics of donor animals (e.g. age, sex, weight): 12-60 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Eye transported same day in Hanks' balanced salt solution (HBBS) in ice packs
- Time interval prior to initiating testing: Corneas prepared immediately on arrival
- indication of any existing defects or lesions in ocular tissue samples: Examined macroscopically and only corneas free of damage used.
- Indication of any antibiotics used: HBBS augmented with penicillin and streptomycin.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75mL - Duration of treatment / exposure:
- 10 mins
- Duration of post- treatment incubation (in vitro):
- After rinsing, 120 mins at 32C.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used. The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders. The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : Yes, 0.9% saline
POSITIVE CONTROL USED : Yes, pure ethanol
APPLICATION DOSE AND EXPOSURE TIME 0.75mL for 10 mins
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
- POST-EXPOSURE INCUBATION: 120 mins at 32C.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: not specified
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader
- Other: corneas retained for histopathology but this was not performed.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: As per UN GHS (<=3 not classified, >55 category 1)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Average of 3 corneas
- Value:
- ca. 1.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- corrected score
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Average of 3 corneas
- Value:
- ca. 1.5
- 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: No
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a guideline and GLP ex-vivo bovine corneal opacity eye irritation study, the substance THI-TM produced minimal effects on the cattle corneas used. The results indicated that the substance does not need to be classified as an eye irritant
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