Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 March 2013 - 19 April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to the OECD test Guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 7,8-benzotricyclo[4.3.0.1(2.5)]deca-3-ene (MTF)
- Substance type: Organic
- Physical state: transparent liquid
- Analytical purity: ca 100%
- Lot/batch No.: M1204
- Expiration date of the lot/batch: 31 December 2015
- Storage condition of test material: Room temperature (ca 20ºC)

Test animals / tissue source

Species:
other: Bovine eyes

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
10 mins (+/- 30 seconds) at 32°C 1°C
Observation period (in vivo):
two hour (+/- 10 minutes) incubation period
Number of animals or in vitro replicates:
n/a

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
Mean
Value:
ca. -1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean
Value:
ca. -1
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive/non-severe eye irritant
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance, MTF, elicited an In Vitro Irritancy Score of -1.0 ± 0.1 and was predicted to be a non-corrosive/non-severe eye irritant.