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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
start 23 June 1997
termination 27 June 1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
The OECD guideline for Testing of Chemicals No. 405, adopted February 24th, 1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Ichthyolic acid, sodium salt
EC Number:
215-671-7
EC Name:
Ichthyolic acid, sodium salt
Cas Number:
1340-06-3
IUPAC Name:
Identification of the UVCB substance by "Chemcial Abstracts Index Name", among others: Ichthyolic Acid, Sodium Salt. No IUPAC name known.
Test material form:
liquid
Specific details on test material used for the study:
ICHTHYOL PALE from regular production at the registrant's manufacturing site (batch 960045) in a 5% buffered aqueous solution.

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
Species/strain/stock/breeder
rabbit/Himalayan/CHR. FRED LEUSCHNER & CO., D-24601 Löhndorf/Post Wankendorf

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml test substance (Ichthyol Pale)/animal
- Concentration (if solution): 5%

Duration of treatment / exposure:
single instillation into the conjunctival sac
Observation period (in vivo):
Examination of eyes prior to the administration and 1, 24, 48 and 72 hours after the administration.
Animals that did not reveal any lesions anymore for 24 hours following the first 72 hours of observation were sacrificed.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of test substance by washing or other measures

SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3/4 defined but not relevant for this study

IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)

CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily descernible
3 diffuse beefy red

Chemosis: lids and/or nictitating membrane
0 no swelling
1 any swelling above normal (including nictitating membranes)
2 obvious swelling with partial eversion of lids
3/4 defined but not relevant for study results

Any further lesions are listed.


TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein (after 24 hours)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Measurements of the cornea opacity score were conducted after one hour already. Also after one hour the score was 0.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Remarks:
Measurement of iris score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Measurement of conjunctival redness score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Measurement of chemosis score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Measurement of opacity score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Measurement of opacity score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Remarks:
Measurement of iris score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Remarks:
Measurement of iris score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Measurement of conjunctival redness score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Measurement of conjunctival redness score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Measurement of chemosis score was conducted after 1 h already. Score after 1 h: 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
Measurement of chemosis score was conducted after 1 h already. Score after 1 h: 0
Irritant / corrosive response data:
Information given in the "results" section
Other effects:
24 hrs fluorescein test: no pathological findings

No systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Ichthyolic Acid, Sodium Salt (ICHTHYOL PALE) was tested on its eye irritation potential according to OECD guideline 405. Under the test conditions a single application of 0.1 ml 5% Ichthyol Pale per animal into the conjunctival sac of the right eye of three rabbits did no cause any changes. The cornea, iris and conjunctivae were not affected by instillation of the test compound. There were no systemic intolerance reactions.