Registration Dossier
Registration Dossier
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EC number: 701-160-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Eye irritation testing of nanomaterials using the EpiOcular™ eye irritation test and the bovine corneal opacity and permeability assay
- Author:
- Kolle SN, Sauer UG, Rey Moreno MC et al.
- Year:
- 2 016
- Bibliographic source:
- Particle and Fibre Toxicology, 13:18 [https://particleandfibretoxicology.biomedcentral.com/articles/10.1186/s12989-016-0128-6]
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)
- Version / remarks:
- 2013
- GLP compliance:
- not specified
Test material
- Reference substance name:
- GRAPHISTRENGTH C100
- IUPAC Name:
- GRAPHISTRENGTH C100
- Reference substance name:
- Tangled Multi-Walled Carbon Nanotubes
- EC Number:
- 701-160-0
- Cas Number:
- 7782-42-5
- Molecular formula:
- Hollow tubular carbon, 1-dimensional nano structures with hexagonal arrangement of carbon atoms
- IUPAC Name:
- Tangled Multi-Walled Carbon Nanotubes
- Test material form:
- solid: nanoform
Constituent 1
Constituent 2
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 20 % (w/w) dry suspension was prepared mixing 750 mg MWCNT NM-402 in highly de-ionized water shortly before application by stirring with a spatula.
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- none
- Number of animals or in vitro replicates:
- 3 corneas
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS: no data
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer (BASF-OP2.0, BASF SE, Germany)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
- Others: histopathological evaluation by light microscopy
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The In Vitro Irritancy Score (IVIS) was calculated per treated cornea and finally the mean IVIS per treatment group ± standard deviation (SD) was determined: IVIS = mean opacity value + (15 x mean permeability value). An IVIS >55 indicates a risk of serious damage to the eyes.
DECISION CRITERIA:
Acceptance criteria laid down in OECD TG 437
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- -3.9
- Vehicle controls validity:
- valid
- Remarks:
- 4.9 ± 5.7
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 123.0 ± 17.4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- -3.8
- Vehicle controls validity:
- valid
- Remarks:
- 4.7 ± 5.7
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 78.5 ± 16.4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- Mean
- Value:
- -0.01
- Vehicle controls validity:
- valid
- Remarks:
- 0.01 ± 0.02
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- 3.0 ± 0.8
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- histopathological observations
- Value:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The in vitro eye irritation potential of Graphistrength C100 (NM-402) was investigated in a BCOP test including histopathology of the bovine corneas. No corneal effects were observed.
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