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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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-7-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate and Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-6-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate
EC Number:
916-837-8
Molecular formula:
C29H16Na4ClN9O12S4
IUPAC Name:
Reaction mass of Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-7-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate and Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-6-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test substance: FAT 40032/D
Batch No.: EN 19721.62
Contents of active ingredients: 93.7 %
Physical properties: powder, solubility in water approx. 100 g/l at 20 °C, pH 6.9
Storage conditions: room temperature
Validity: December 1991
Test material received: January 16, 1987

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 1 female rabbit, checked for normal eye conditions, weighing between 24 90 g (approx. 12-14 weeks old). The animal was housed individually in a metal cage identified with a numbered ear tag, kept at a constant room temperature of 20±3 °C, àt a relative humidity of 30-70 % and on a 12 hours light cycle day. The rabbit received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water. All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results are available at the animal supply office. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). Results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to Ciba-Geigy Ltd., as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceuticals Division, Ciba-Geigy Ltd. The body weight was recorded at start and on days 3, 7, and 14 of the test.

Test system

Amount / concentration applied:
0.1 ml (66 mg) of FAT 40032/D was placed into the conjunctival sac of the left eye of animal.
Duration of treatment / exposure:
1 second
Observation period (in vivo):
1, 24, 48, 72 hours , 7 and 14 days
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
1 Female
Details on study design:
The left eye of animal was treated with the test substance after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
The right eye remained untreated and served as a control. The animal was checked daily for systemic symptoms and mortality.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40032/D can be classified as non-irritant according to the EEC Directive No.83/467/1983.
Executive summary:

A study was performed to determine the eye irritation potential of FAT 40032/D in rabbits. There were some mild reactions observed in the eyes of the animals. Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 14 days to determine the reversibility of the eye reactions. Slight reddish staining of the cornea was seen, disappearing within 14 days. According to the EC classification of the results obtained 24 to 72 hours after instillation, FAT 40032/D can be classified as non-irritant to albino rabbit's eye. The eye reactions were reversible until the end of the observation period of day 14.