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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Federal Register Vol. 38 , Nr . 187 , S . 27019 , 1973
Deviations:
yes
Remarks:
6 Animals used;
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
EC Number:
249-352-9
EC Name:
Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
Cas Number:
28983-56-4
Molecular formula:
C37H29N3O9S3.2Na
IUPAC Name:
Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
100 mg/eye
Duration of treatment / exposure:
washing after 24 h examination
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test material was moistened with saline and applied to the conjunctival sac of one eye. 1, 7, 24, 48 and 72 hours later the eyes were evaluated by means of a magnifying glas. 24 hours after aplication the eyes were washed with saline. at 48 and 72 hours eyes were additionally treated with 0,01% Fluorescine to increase sensitivity of the examination. Findings were evaluated according to "Appraisal of the Safety of Chemicals in Foods , Drugs and Cosmetics ", FDA , Austin, Texas , S . 51, 1975.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour after application
Score:
ca. 7
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not irritant on rabbit eyes.
Executive summary:

The test material was moistened with saline and applied to the conjunctival sac of one eye per rabbit in 6 animals. 1, 7, 24, 48 and 72 hours later the eyes were evaluated by means of a magnifying glas. 24 hours after aplication the eyes were washed with saline. At 48 and 72 hours eyes were additionally treated with 0,01% Fluorescine to increase sensitivity of the examination.

Findings were evaluated according to "Appraisal of the Safety of Chemicals in Foods , Drugs and Cosmetics ", FDA , Austin, Texas , S . 51, 1975.

The maximal irriation index was recorded at 1 h after application as 7 of 110.

The test item was not irritant on rabbit eyes.