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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Principles of method if other than guideline:
In order to evaluate the eye irritation of the test substance, a single dose was applied into the eyes of six rabbits. After the exposure for each animal one eye was rinsed and the other one was not rinsed. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate
EC Number:
279-093-7
EC Name:
Trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate
Cas Number:
79135-92-5
Molecular formula:
C36H25N8Na3O12S3
IUPAC Name:
trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
not specified
Controls:
no
Duration of treatment / exposure:
single application
Observation period (in vivo):
24, 48, 72 h and 7 d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
One eye was rinsed and the other one was not rinsed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #5, #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
cornea opacity score
Basis:
animal: #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: #1, #2, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #2, #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #3, #5, #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #1, #3, #5, #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: rinsed eye

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The test substance was found to be not irritant when applied to intact rabbit eye.
Executive summary:

The substance was tested for eye irritation according to an internal method: a single dose was applied into the eyes of six rabbits. After the exposure for each animal one eye was rinsed and the other one was not rinsed. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7 days.

Considering the rinsed eye, under this study conditions the substance resulted in no effects on cornea and iris (mean scores 0) except in animal #4 (mean cornea score 0.33) and in animal #3 (mean iris score 0.33). Three animals (#3, #5 and #6) showed no effects on conjunctivae (redness and chemosis mean scores 0). Effects on conjunctivae were observed in the other three animals: redness mean scores were 1.33 and 1 in animal #1 and animals #4 and #2 respectively; chemosis mean scores were 0, 1 and 0.67 in animals #1, #2 and #4 respectively. Higher scores on cornea, iris and conjunctivae were observed in the unrinsed eye.

At the end of the observation period (7 days) all the irritation effects were fully reversible except from conjunctivae redness and chemosis scores that were observed in animal #1 and in animal #4 respectively (grade 1 after 7 days for both effects). In these both cases, a decreasing trend of observed values occurred during the 7-day study period. This trend was also observed in the worst case for the unrinsed eye of the same two animals. Furthermore, the trend towards lower conjunctival scores was found in all other animals. Therefore, it is reasonable to think that reversibility within 21 days should occur even if at the present study it was not possible to observe the fully reversibility of all the effects within the 7-day study period.