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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study before GLP, but reporting the relevant details

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals employed
Qualifier:
according to guideline
Guideline:
other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no
Remarks:
pre-dates GLP-regulation

Test material

Constituent 1
Reference substance name:
pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate
EC Number:
944-710-7
Molecular formula:
not available because multi-constituent substance
IUPAC Name:
pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg / eye
Duration of treatment / exposure:
no washing
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6
Details on study design:
Six albino rabbits are used for each test substance. Animal facilities for such procedures shall be so designed and maintained so to exclude sawdust, wood chips, or other extraneous materials that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pulling the lower Iid away from the eyeball to form a cup into which the test substance is dropped. The Iids are then gently held together for one second and the animal is released.
The other eye, remaining untreated, serves as a control.
For solids or pastes, 100 milligram of the test substance is used.
The eyes are not washed following instillation of test material.
The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours. Reading of reaction is facilitated by use of o binocular Ioupe, hand slit-lamp, or other expert means.
After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is dropped directly on the cornea. After flushing out the excess fluorescein with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized in a darkened room under ultra-violet illumination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
ca. 1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 to 7 days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 to 7 days
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
7 d
Score:
1
Reversibility:
not fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be "non-irritant" to the rabbit eye
Executive summary:

The procedure employed was tl:at prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42.

On this occasion 100 mg of the test item was instilled into one eye of each animal, the other eye remaining untreated, served as a control.

The ocular reactions were scored by the method described by J. H . Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p51, 1959 and categorized from the mean values as recommended by the ETAD Sub-committee for Toxicology.

Mild conjunctival reactions only were observed in three animals. Three animals did not show any observable response to treatment throughout the 7 days observation period.

Maximum mean Draize score = 0.5

CONCLUSION The test item is considered to be "non-irritant" to the rabbit eye.