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Toxicological information

Eye irritation

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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:
2016
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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
GRAPHISTRENGTH C100
IUPAC Name:
GRAPHISTRENGTH C100
Test material form:
solid: nanoform

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.