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EC number: 249-236-8 | CAS number: 28804-46-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers
- EC Number:
- 249-236-8
- EC Name:
- Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers
- Cas Number:
- 28804-46-8
- Molecular formula:
- C16H14Cl2
- IUPAC Name:
- Reaction product of tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene with chlorine
- Test material form:
- solid: granular
1
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- other: corn oil
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- One set of corneas were treated with 750 mg (pulverized) of test item (as such). One set of corneas were treated with 750 μL of the prepared test item [20% (w/v) concentration in corn oil]
- Duration of treatment / exposure:
- 4 h ± 5 minutes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- corneas treated with 750 mg DPX-C (Di-Cloro-Di-p-Xililene)
- Value:
- 0.42
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- corneas treated with 750 mg DPX-C (Di-Cloro-Di-p-Xililene) (suspension) at 20% (w/v)
- Value:
- 0.57
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: No Category
- Conclusions:
- Based on the results of this study, an indication of the classification for DPX-C (Di-Cloro-Di-p-Xililene) is as follows:
Classification (OECD 437): No Category. - Executive summary:
This study was conducted to evaluate theocular irritancy of a DPX-C (Di-Cloro-Di-p-Xililene)in compliance with the OECD test guideline forBCOP Test.
InBCOP test, five sets each consisting of three corneas were tested.First set served as vehicle control and was treated with 750 μL normal saline. The second set was treated with 750 mgDPX-C (Di-Cloro-Di-p-Xililene) (pulverized and was applied to the surface of cornea as such)while the third set served aspositive control and was treated with750 μL20% (w/v) imidazole innormal saline. In addition to this one set was treated with corn oil and one set was treated with 750 μLDPX-C (Di-Cloro-Di-p-Xililene) (suspension) at 20% (w/v) concentration in corn oil.Post application the corneas were incubated for approximately 4 h at32 ºC.At the end of the incubation period reading for opacity were taken.
Post opacity reading permeability was measured by applying1 mL of fluorescein sodium solution (5 mg/mL)on to the anterior surface of the cornea and was incubated forapproximately90 min at32 ºC. At the end of the incubation period OD was measured at 490 nm for the fluid collected from the posterior chamber.
The meanIn-VitroIrritatancy Score(IVIS) ofnormal saline (vehicle control), corn oiland750 μL20% (w/v) imidazole innormal saline(positive control)treated corneaswere found to be -0.95, 0.62 and 69.49,respectively,which confirmed the reliability of the test procedure. The IVIS score for the corneas treated with 750 mgDPX-C (Di-Cloro-Di-p-Xililene) and750 μLDPX-C (Di-Cloro-Di-p-Xililene) (suspension) at 20% (w/v) concentration in corn oil were found to be0.42 and 0.57, respectively.
Based on the results of this study, an indication of the classification forDPX-C (Di-Cloro-Di-p-Xililene)is as follows:
Classification (OECD 437): No Category.
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