2-[10-(acetyloxy)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

ANNEX - A Sequential Testing Strategy for Eye Irritation and Corrosion .

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Draft Updated ICCVAM Recommended HET-CAM Protocol.

Principles of method if other than guideline:

Results from in vitro or ex vivo tests: Substances that have demonstrated corrosive or severe irritant properties in an in vitro or ex vivo test that has been validated and accepted for the assessment specifically of eye or skin corrosivity/irritation, need not be tested in animals. It can be presumed that such substances will produce similar severe effects in vivo.
Even if HET-CAM assay have not achieved the OECD validation, it is accepted for the purpose of "TESTING AND EVALUATION STRATEGY FOR EYE IRRITATION/CORROSION" as reported in ANNEX of test method B.5.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Prednisolone

EC Number:

200-021-7

EC Name:

Prednisolone

Cas Number:

50-24-8

Molecular formula:

C21H28O5

IUPAC Name:

11,17,21-trihydroxypregna-1,4-diene-3,20-dione

Test material form:

solid: particulate/powder

Details on test material:

- Storage conditions of the test material: at room temperature, protected from light

Test system

Vehicle:

physiological saline

Remarks:

B. Braun Melsungen, lot n. 017A122, expiry date: 03/2013.

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Prednisolone 100 % applied to an area of 25 % of the chorioallantoic membrane.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 mL of standard solution (0.9 % NaCl)
- Lot/batch no. 017A122

Duration of treatment / exposure:

The reaction on the CAM were observed over a period of 5 minuted monitoring the appearance of:
Haemorrhage (bleeding);
Vascular lysis (blood vessel disintegration);
Coagulation (protein denaturation intra- and extravascular).

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: Prednisolone was left in contact with the egg membrane for 5 minutes.

SCORING SYSTEM: the time for each reaction to occur was recorded and an irritation score (IS) was calculated:
IS = [(301-sec H)/300] x 5 x S+ [(301-sec L)/300] x 7 x S + [(301-sec C)/300] x 9 x S

sec = second of first occurence of reaction
H = Haemorrhage
L = Vascular Lysis
C = Coagulation
S = 0.1 if H, C, L is grade 1 (weak reaction)
S = 0.5 if H, C, L is grade 2 (moderate reaction)
S = 1 if H, C, L is grade 3 (strong reaction)
The mean score was calculated from irritation scores for each egg for each test group.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The eye irritancy potential of the test item was investigated in the chorioallantoic membrane assay.
The test item was tested as provided by the sponsor in order to find any irritancy potential.
The calculated mean irritation score was 0.
The test item was classified as non-irritant.
The positive and negative controls were within the historical control data range demonstrating the validity and sensitivity of the test.

Categories Display