9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18/08/2016 -

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 160 (Bovine Corneal opacity and permeability (BCOP) and isolated chicken eye (ICE) Test methods:collection of tissues for histological evaluation and collection of data on non-sever irritants)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Regulation EU N.1152/2010 amending Regulation No.440/2008 EU-Method B.47

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

EC Number:

213-563-4

EC Name:

9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

Cas Number:

981-34-0

Molecular formula:

C22H28O5

IUPAC Name:

17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione

Test material form:

solid: particulate/powder

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: bovine cornea collected from freshly slaughtered cattle
- Characteristics of donor animals (e.g. age, sex, weight): 12-60 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hank's balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicilin). Then, the corneas were dissected and incubated in medium at 32+/-1°C in an incubation chamber for 1 h.

Test system

Vehicle:

Hank's balanced salt solution

Duration of treatment / exposure:

Exposure time on the corneas was 3 hours and 55 minutes at 32+/- 1°C.

Duration of post- treatment incubation (in vitro):

The chambers were incubated for 85 min at 32 +/- 1°C.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

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:

GHS criteria not met

Conclusions:

Under the conditions of this test, the test item Beta-Methylepoxy showed no effects on the cornea of the bovine eye. the calculated IVIS (in vitro irritancy score) is 1.17.
According to OECD Guideline no.437 (Jul.2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serius eye damage.
The negative control (HBSS-solution) and the positive control (20% imidazole solution) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.