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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:
May 1974
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from experimental report

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
Principles of method if other than guideline:
An eye irritation study of test chemical was conducted in Russian breed rabbits.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
EC Number:
235-468-7
EC Name:
Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Cas Number:
12237-62-6
Molecular formula:
[C24N3H28] Cu2Fe(CN)6
IUPAC Name:
ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Test material form:
solid
Details on test material:
IUPAC name: ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Substance type: Organic
Physical state: Solid
Molecular Formula: [C24N3H28] Cu2Fe(CN)6
Molecular Weight: 697.54 g/mol

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: The substance was tested on 6 rabbits (3 males/3 females) of.the Russian breed, which were kept separately in V2A wire cages
- Diet (e.g. ad libitum): fed on NAFAG, Gossau SG, rabbit food and water ad libitum
- Only rabbits showing normal ophthalmic findings were included in the test.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment
Observation period (in vivo):
The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6 (3 males/3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

Procedure : Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula.After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
TOOL USED TO ASSESS SCORE: slit lamp.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae

Any other information on results incl. tables

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The primary-irritation index (overall irritation score), which serves as a measure of the acute irritation provoked by the substance, was estimated to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore the test chemical was considered as non-irritant to the eye of rabbits.
Executive summary:

An eye irritation study of test chemical was conducted in six (3 males/3 females) Russian breed rabbits. The study was performed as per the procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The total maximum scores are as follows: 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was estimated to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae out of maximum score of 110. Since there were no evidence of any signs of ocular lesions, the test chemical was considered to be not irritating to the rabbits’ eye.