Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
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)
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

Constituent 1
Chemical structure
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.