Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 October to 13 October 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): Tetracyclo[4.4.0.1(2,5).1(7,10)]dodeca-3-ene
- Substance type: Monomer for polycycloolefin production
- Physical state:Transparent liquid
- Analytical purity: 100%
- Lot/batch No.: M0904
- Expiration date of the lot/batch: 31 December 2013
- Storage condition of test material: Refrigerated (ca 4°C), in the dark, under N2

Test animals / tissue source

Species:
other: Bovine eyes

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 750 µl

Duration of treatment / exposure:
10 min ± 30 s
Observation period (in vivo):
n/a
Number of animals or in vitro replicates:
n/a
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 2 h 10 m

SCORING SYSTEM: opacitometer

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
1.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Throughout the assay the corneas were examined for opaque spots or other irregularities. Following treatment with test substance, TCD, the corneas were noted as clear. The corneas treated with the positive control, sodium hydroxide 10% (w/v), were very opaque and the corneas treated with the negative control, 0.9 % saline, were clear.

Any other information on results incl. tables

The test substance was diluted to 10 % w/v with 0.9 % saline to obtain an aqueous solution for pH measurement. The pH of the test sample, measured using universal pH sticks, was approximately 7.0.

The positive control, sodium hydroxide (10 %), elicited an In Vitro Irritancy Score of 277.1 ± 19.1. This value was within the historical range (mean ± 2 x SD, 256.5 - 314.9) for the assays performed to date.

The negative control, 0.9 % saline, opacity mean change value was 1.0 which was below the maximum acceptance value of 2.0. The permeability mean of the negative control was 0.018 which was below the maximum acceptance value of 0.1.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, TCD, elicited an In Vitro Irritancy Score of 1.5 ± 0.7 and was predicted to be a non-corrosive/ non-severe eye irritant.