D-Glucitol, 1,3:2,4-bis-O-[(4-chlorophenyl)methylene]-

Eye irritation

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

Guideline:

other: OECD 437 (dated Sept. 2009)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

EC Number:

700-591-1

Cas Number:

82203-23-4

Molecular formula:

C20H20Cl2O6

IUPAC Name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

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).