Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-01-18 - 2012-02-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 437 (dated Sept. 2009)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Physical state: solid (white powder)
- Expiration date of the lot/batch: December 2012
- Storage condition of test material: Room Temperature: (20 ± 5°C); Keep away from humidity

Test animals / tissue source

Species:
other: fresh bovine corneas
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Fresh bovine eyes were obtained from a slaughterhouse on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank's balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then the corneas were dissected and incubated in medium at 32 ± 1°C in an incubation chamber for 1 hour.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Negative Control: Sodium chloride solution (0.9% NaCI); Positive Control: Imidazole solution( 20% C3H4N2, dissolved in 0.9% NaCI)
Amount / concentration applied:
Tissue 1: 64.3 mg
Tissue 2: 96.1 mg
Tissue 3: 71.4 mg
Duration of treatment / exposure:
4h±5min
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
not applicable

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
three measurements
Value:
>= 0.338 - <= 0.505
Vehicle controls validity:
not examined
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: none reported

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (IVIS: 0.796 - 1.303)
- Acceptance criteria met for positive control: yes (IVIS: 82.056 - 100.612)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.417. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses no eye irritation potential (according to ICCVAM).