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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Referenceopen allclose all

Reference Type:
other: Protocol Draft
Title:
Draft Updated ICCVAM Recommended HET-CAM Protocol
Author:
ICCVAM
Year:
2010
Bibliographic source:
ICCVAM Test Method Evaluation Report: Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products - NIH Publication No. 10-7513
Report Date:
2010
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
ANNEX - A Sequential Testing Strategy for Eye Irritation and Corrosion .
Qualifier:
according to
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 heve 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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Prednisolone
- Physical state: chrystalline white powder
- Analytical purity: 99.8 %
- Lot/batch No.: 1153320/MP36894
- Expiration date of the lot/batch: 21/10/2012
- Storage condition of test material: at room temperature, protected fron light

Test system

Vehicle:
physiological saline
Remarks:
B. Braun Melsungen, lot n. 017A122, expiry date: 03/2013.
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 vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not relevant
Score:
0
Max. score:
21
Remarks on result:
other: Prednisolone was classified as non-irritant.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Read-across approach
Conclusions:
On the basis of the read-across results, interpreted according to ICCVAM Recommended HET-CAM Protocol, because the test product "PREDNISOLONE" is considered NOT IRRITANT for the eye, also the structurally related compound 6ß-chloro-17α-hydroxypregna-4-ene-3,20-dione, 17-acetate should be considered as NOT IRRITANT.