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Diss Factsheets

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: well-documented, scientifically acceptable study report. Little information on test item. Only 8 days observation period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
8-day observation period.
Principles of method if other than guideline:
according to Federal Register 38 , No. 187, § 1500.42, p. 27029 of Sep. 27, 1973 (Draize test)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)
EC Number:
288-107-0
EC Name:
Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)
Cas Number:
85650-96-0
Molecular formula:
C32 H15 Cu N8 O3 S .C18 H37 N .H
IUPAC Name:
Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine
Details on test material:
Name in report: Oleylammoniumsalz der Cu- phthalocyanin- sulfosäure

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Mean body weight: male 2.32 kg, females 2.47 kg
The animals were offered a standardized animal laboratory diet.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
77 mg (corresponding to 0.1 ml bulk volume)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
Scoring according to Draize.
The test substance was not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
2
Reversibility:
other: reversible in 2/3 animals within 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.8
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: Redness (score 1) on day 8
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible

Any other information on results incl. tables

Table 1: Individual results

cornea cornea conjunctivae conjunctivae conjunctivae
Time point Animal no. opacity area iris redness chemosis discharge remarks
24h 1 2 4 1 2 2 3 E/NA/PV
24h 2 1 4 1 2 2 2 NA
24h 3 1 4 1 2 2 2 NA
48h 1 2 4 1 2 2 3 E/NA/PV
48h 2 1 4 0 2 2 1 NA
48h 3 1 3 1 2 2 1 NA
72h 1 2 2 1 2 2 3 E/NA/PV/J
72h 2 1 2 0 2 2 1 NA/J
72h 3 1 2 1 2 2 1 NA/J
8 days l 0 0 0 1 0 1 NA
8 days 2 0 0 0 l 0 0 NA/J
8 days 3 1 1 0 1 0 0 NA/J

J = Iris partially coloured

NA = Scar

PV = pupil narrowed

E = pus/sanies

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)