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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl Macrolex Blau RR fl. was applied into the conjunctival sac of the right eye of 3 rabbits. Reading was carried out 1, 24, 48 and 72 h, and 8 d afterthe application of the test substance.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone
EC Number:
251-178-3
EC Name:
1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone
Cas Number:
32724-62-2
Molecular formula:
C36H38N2O2
IUPAC Name:
1,4-bis[(2,6-diethyl-4-methylphenyl)amino]-9,10-dihydroanthracene-9,10-dione
Details on test material:
816-119 Macrolex Blau RR fl.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 rabbits

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
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Macrolex RR fl. produced a primary irritation value of 0 concerning irritation in mucous membrane on the eye

Applicant's summary and conclusion

Interpretation of results:
not irritating
Executive summary:

100 µl Macrolex Blau RR fl. was applied into the conjunctival sac of the right eye of 3 rabbits. Reading was carried out 1, 24, 48 and 72 h, and 8 d afterthe application of the test substance.

Macrolex RR fl. produced a primary irritation value of 0 concerning irritation in mucous membrane on the eye. Thus, the test substance is not irritating to the eyes.