Registration Dossier
Registration Dossier
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EC number: 235-469-2 | CAS number: 12237-63-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 45160:2.
Eye irritation
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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- EC Number:
- 235-469-2
- EC Name:
- Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- Cas Number:
- 12237-63-7
- Molecular formula:
- C34H31N8O3Cu3Fe
- IUPAC Name:
- ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- 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
Constituent 1
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.
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