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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:
February 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Assessment of a possible irritating potential of CI Pigment Red 169 to the eye and to the eye mucosa of rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- IUPAC name: Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- Common name: C.I. Pigment Red 169
- Molecular formula: C62H58Cu3FeN10O6
- Substance type:Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Male and female
- Source: Gaukler; D-6050 Offenbach 1 Main, Frg
- Weight At Study Initiation: Mean Weight (Kg) Male: 3.27 , Female: 3.23
- Housing: Cage made of stainless steel with wire mesh walk floors.
- Floor Area: 40 Cm X 51 Cm
- Diet (E.G. Ad Libitum): KLIBA 341, 4 mm (About 130 G per animal per day)
- Water (E.G. Ad Libitum): About 250 mL tap water per animal per day
- Acclimation Period: At least 8 days before the beginning of the study; same housing conditions as during the study
- Bedding: No Bedding in the cages; sawdust in the waste trays

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Day/Night Rhythm: 12 H/12 H (6.00 - 18.00 Hours/18.00 - 6.00 Hours)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 20 mg of the comminuted test substance)
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1 hr, 24hr, 48hr, 72hr, 8 Day, 15 Day and 21 Day after application
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
MALE : 3
FEMALE : 3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: not washed

SCORING SYSTEM: ACCORDING TO 83/467/EEC CRITERIA OF JULY 29TH, 1983

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Following symptoms appeared:
after 24 hours of exposure: small retractions in the eyelid, pupil contracted, irritation index could not be read because of staining due to the color of test substance.
after 72 hours: Suppuration
after 8 days: Loss of hair at margins of eyelid
after 15 days: Marginal vascularization of the cornea
after 21 days: Pannus

Any other information on results incl. tables

Calculation of the mean was done according to 83/467/EEC criteria of July 29th, 1983 (for calculation of the means of opacity, iris, redness and swelling, only the readings of 24, 48 and 72 hours are used).

RESULTS ACUTE EYE IRRITATION (OECD)

Serial number

1

2

3

4

5

6

Animal number

0821

0846

0884

0912

0906

0907

Animal weight(kg)

3.46

3.31

3.32

2.91

3.09

3.10

Sex

Fe

Ma

Fe

Fe

Ma

Ma

 

Readings

Animal

Cornea

Iris

Conjunctivae

Symptoms

OP

AR

RED

SW

DI

1 hour

1

0

0

0

1

1

2

S00

S00

2

0

0

0

2*

1

3

3

0

0

0

2*

1

2

4

0

0

0

2

1

2

5

0

0

0

1

1

2

6

0

0

0

2

1

2

24 hour

1

0

0

0

2

1

1

RE

PC/S00

2

0

0

0*

2*

2

3

3

0

0

0

1

2

2

4

0

0

0

2

1

1

5

0

0

0

2

1

1

6

0

0

0

2

1

3

48 hours

1

0

0

0

1

0

0

RE

2

1

2

1

2

2

3

3

0

0

0

1

1

1

4

0

0

0

2

1

0

5

0

0

0

2

0

0

6

0

0

0

2

1

2

72 hours

 

1

0

0

0

0

0

0

RE/S06

PC/S

2

1

4

1

2

2

3

3

0

0

0

0

0

1

4

0

0

0

1

1

0

5

0

0

0

1

0

0

6

0

0

0

1

1

2

8 days

1

 

 

 

 

 

 

 

PC/LH

 

 

 

RE

2

1

4

1

2

2

2

3

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

0

0

0

1

1

2

15 days

1

 

 

 

 

 

 

 

PC/LH/MV/RE/S

 

 

 

RE/MV/PC

2

2

2

1

2

1

3

3

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

1

2

0

0

0

0

21 days

1

 

 

 

 

 

 

LC/MV/RE/S/PA

 

 

 

 

LC/MV/RE/PC

2

2

2

1

2

1

2

3

0

0

0

00

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

1

2

1

0

0

0

ME

1

0.0

0.0

1

0.3

 

2

0.7

0.7

2

2

3

0

0

0.7

1

4

0

0

1.7

1

5

0

0

1.7

0.3

6

0

0

1.7

1.0

ME

 

0.1

0.1

1.4

0.9

 

KEY: MA = MALE

FE = FEMALE

ME = MEAN

H = HOUR

0 = DAY

EXPLANATIONS OF SYMPTOMS:

S00 - IRRITATION INDEX COULD NOT BE READ BECAUSE OF STAINING DUE - TO THE COLOR OF THE TEST SUBSTANCE

S06 - FIRST STUDY DISCONTINUED AFTER 72 H BECAUSE NO IRRITATION COULD BE OBSERYED AT THAT TIME

LH - LOSS OF HAIR AT MARGINS OF EYELIDS

LC - LOSS OF CORNEAL TISSUE

MV - MARGINAL VASCULARIZATION OF THE CORNEA

PC - PUPIL CONTRACTED

PA - PANNUS

RE - SMALL RETRACTIONS IN THE EYELIDS

S - SUPPURATION

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The mean scores for cornea, iris, conjunctival swelling and chemosis were 0.1,0.1,1.4 and 0.9 respectively. Also,redness and contracted pupils loss of corneal tissue, marginal vascularization was observed in the treated eyes till 21 days of observation.
Based on these observations and scores, the test chemical can be considered to be irritating to rabbit eyes.
Executive summary:

A study was performed for assessment of a possible irritating potential of CI Pigment Red 169 to the eye and to the eye mucosa of rabbits. The study was conducted according to OECD 405 Guidelines. 6 (3 male, 3 female) Vienna White rabbits were used for the study. 0.1 ml bulk volume (about 20 mg of the comminuted test substance) was instilled into the right eyelid of the test animals. Untreated eyes served as negative control. The treated eyes remained unwashed throughout the study. The treated eyes were observed for signs of irritation and scored at 1 hr, 24hr, 48hr, 72hr, 8 Day, 15 Day and 21 Day after application. The mean scores for cornea, iris, conjunctival swelling and chemosis were 0.1,0.1,1.4 and 0.9 respectively. Also, redness and contracted pupils loss of corneal tissue, marginal vascularization was observed in the treated eyes till 21 days of observation. Based on these observations and scores, the test chemical can be considered to be irritating to rabbit eyes.