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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:
comparable to guideline study with acceptable restrictions
Justification for type of information:
data is from experimental reports

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38, No. 187, § 1500.42, 1973 (Draize test)
Principles of method if other than guideline:
To assess the ocular irritation potential of N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-N-methylmethanaminium acetate in rabbits
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material : N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-N-methylmethanaminium acetate- Molecular formula: C33H32N3C2H3O2- Molecular weight : 529.68 g/mol- Smiles notation : [N+](=C1/C=CC(\C=C1)=C(\c1ccc(c2ccccc12)Nc1ccccc1)c1ccc(cc1)N(C)C)(\C)C.C(C)(=O)[O-]- InChl : 1S/C33H31N3.C2H4O2/c1-35(2)27-18-14-24(15-19-27)33(25-16-20-28(21-17-25)36(3)4)31-22-23-32(30-13-9-8-12-29(30)31)34-26-10-6-5-7-11-26;1-2(3)4/h5-23H,1-4H3;1H3,(H,3,4)- Substance type:Organic- Physical state:Liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Weight at study initiation:ca. 3 - 4 kg- Housing:One animal per cage- Diet (e.g. ad libitum): a standardized animal laboratory diet, ad libitum- Water (e.g. ad libitum): tap water ad libitum.- Acclimation period:at least 3 daysENVIRONMENTAL CONDITIONS- Temperature (°C):22 +/- 1°C- Humidity (%):55 +/- 10%- Photoperiod (hrs dark / hrs light):12 h light, 12 h darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test substance was not washed out.Readings: 1 h, 24 h, 48 h and 72 h after instillation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
1.9
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
3.2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Due to substance colouring, conjunctivae score was not assessed.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Conjunctivae score was not assessed due to staining of the test chemical. The effects observed in the rabbit eyes were not reversible even after 72 hours. The mean scores for corneal opacity, iris and chemosis after 24,72 hours of observation were 3.3, 1.9, 3.2 respectively.Based on the scores, test chemical acetate can be considered to be irritating to rabbit eyes.
Executive summary:

The ocular irritation potential of test chemical acetate was assessed in rabbits according to Fed. Reg. 38, No. 187, § 1500.42, 1973 (Draize test) Guidelines. 100 mg of the undiluted test chemical was instilled into one eye of the 6 albino rabbits. The untreated eye served as control. The animals were exposed to the test chemical for 24 hours, and the treated eyes remained unwashed throughout the study. Rabbits were observed for signs of irritation 1 h, 24 h, 48 h and 72 h after instillation of the test chemical. The ocular reactions at 24 and 72 hours were scored according to method of Draize.

Conjunctivae score was not assessed due to staining of the test chemical. The effects observed in the rabbit eyes were not reversible even after 72 hours. The mean scores for corneal opacity, iris and chemosis after 24,72 hours of observation were 3.3, 1.9, 3.2 respectively.

Based on the scores, the test chemical acetate can be considered to be irritating to rabbit eyes.