Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP.

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Molecular formula:
C11H22O
IUPAC Name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Test material form:
other: liquid
Details on test material:
Identification: Super Muguet
Batch Number: SC00011682
CAS Number: 26330-64-3
EC Number: 247-615-2 + 247-616-8
Molecular Formula: C11H22O
Molecular Weight: 170.30 g/mol
Expiration Date: 20 June 2016
Description: Clear, colourless liquid
Purity: 98.27 %
Storage Conditions: Sealed container, 15 - 30 °C, in the dark

Test animals / tissue source

Species:
other: bovine
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Corneas taken from bovine eyes obtained from a local abattoir. The eyes were removeed after slaughter, completely immersed in Hanks' Balanced Salkt Solution in a suitably sized container and transported on the same day to the testing facility. On arrival at the test facility the eyes were carefully examined for defects including increased opacity, scratches and neovascularisation. Only conreas free from such defects were used.
The corneas were then excised from the eyes and loaded onto the specifically designed holders. Both chambers of each holder were filled with pre-warmed Minimal Medium (MEM), with the posterior chamber filled first, ensuring that no bubbles were formed. The holders were incubated at 32 °C +/- 1 °C for 1 hours. After the incubation, the media was removed from both the anterior and posterior chambers. Fresh media was added to the posterior chamber first and then the anterior chamber (this media replacement order ensured the cornea retained its hatural curvature as much as possibleP. The opacity of each cornea was measured using an opacitometer.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The negative control substance was 0.9% sodium chloride solution and the positive control substance was dimethyl formamide
Amount / concentration applied:
A volume of 750 µL of the test material was applied to each of the three corneas
Duration of treatment / exposure:
The corneas were incubated for 10 minutes at 32 °C after the test material was applied. After this incubation, each cornea was washed with media containing phenol red until this indicator showed no pH effect occuring. The corneas were then washed once in media without phenol red and the opacities were measured.
Number of animals or in vitro replicates:
3 corneas
Details on study design:
Fresh corneas, mounted onto specifically designed holders were treated topically with the test material. Eye corrosion/severe irritation potential was based on the combined effect of the test article on the opacity of the cornea following the treatment and the cornea's ability to resist penetration of a fluorescent dye through the tissue.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: corrected opacity
Basis:
mean
Time point:
other: NA
Score:
21.7
Irritation parameter:
other: optical density
Basis:
mean
Time point:
other: NA
Score:
0.516
Irritation parameter:
other: IVIS
Time point:
other: NA
Score:
29.4
Remarks on result:
other: IVIS = mean opacity value + (15 x mean permeability value)

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test article, Super Muguet, produced an IVIS score of 29.40. The assay was considered valid as the assay acceptance criteria were met.