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EC number: 278-150-3 | CAS number: 75247-18-6
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (no test substance purity, no 72 h score, 2 animals, only 50 mg test substance applied, only 8 day observation period, and findings not fully reversed)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no test substance purity, no 72 h score, 2 animals, only 50 mg test substance applied, only 8 day observation period, and findings not fully reversed)
- Principles of method if other than guideline:
- BASF-test:
50 mg of the test substance were applied to the conjunctival sac of one eye of two white Vienna rabbits. Talcum powder was used as a control. Animals were observed for 8 days and skin changes were observed on working days. The substance was not washed out. Findings were graded as described in OECD test guideline 405. - GLP compliance:
- no
Test material
- Reference substance name:
- [N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)
- EC Number:
- 278-150-3
- EC Name:
- [N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)
- Cas Number:
- 75247-18-6
- Molecular formula:
- C47 H49 Cu N11 .3 C18 H30 O3 S
- IUPAC Name:
- Copper,N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyanine-C,C,C-trimethanaminato(2-)-κN29,κN30,κN31,κN32]-,dodecylbenzenesulfonate (1:3)
- Details on test material:
- Please refer to chapter confidential details on test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.06 kg, female: 2.73 kg
ENVIRONMENTAL CONDITIONS: not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 mg - Duration of treatment / exposure:
- single exposure, no rinsing conducted
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no rinsing conducted
SCORING SYSTEM
- evaluation was carried out according to the Draize scoring system
TOOL USED TO ASSESS SCORE
- fluorescein at the end of the end of observation period
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1-2)
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: 1 h after administration until the end of the observation period: opacity (score 1) in both animals; see table below for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1-2)
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Score 1 at the end of the observation period; see table below for details
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 1 h after administration: chemosis (score 1); see table below for details
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 1 h after administration: chemosis (score 1); see table below for details
- Irritant / corrosive response data:
- Reading after 1 h: slight redness, slight edema and slight opacity (score 1), secretion, blue substance residuals; all findings in both animals
Reading after 24 h: marked redness (score 2) in one and slight redness (score 1) in the other animal, slight edema (score 1) in one animal, slight opacity (score 1) and scar formation in both animals, smeary overlay in one animal;
Reading after 8 d: slight redness (score 1) in one animal, slight opacity (score 1) and scars in both animals, smeary overlay in one animal. - Other effects:
- Blue substance remnants and secretion in both animals until 3 h after administration. Scar formation 24 h after administration in both animals. Additionally, smeary overlay was detected in one animal until the end of the observation period.
Any other information on results incl. tables
| Animal | Reading | Opacity | Iritis | Redness | Chemosis | Comments |
| 1 | 10 min | 0 | 0 | 1 | 0 | blue substance remnants, secretion |
| 2 | 10 min | 0 | 0 | 1 | 0 | blue substance remnants, secretion |
| 1 | 1 h | 1 | 0 | 1 | 1 | substance remnants, secretion |
| 2 | 1 h | 1 | 0 | 1 | 1 | substance remnants, secretion |
| 1 | 3 h | 1 | 0 | 1 | 1 | substance remnants |
| 2 | 3 h | 1 | 0 | 1 | 1 | substance remnants, secretion |
| 1 | 24 h | 1 | 0 | 1 | 0 | scar formation |
| 2 | 24 h | 1 | 0 | 2 | 1 | scar formation, smeary overlay |
| 1 | 48 h | 1 | 0 | 1 | 0 | scar |
| 2 | 48 h | 1 | 0 | 2 | 0 | scar, smeary overlay |
| 1 | 5 d | 1 | 0 | 1 | 0 | scar |
| 2 | 5 d | 1 | 0 | 2 | 0 | scar, smeary overlay |
| 1 | 7 d | 1 | 0 | 0 | 0 | scar |
| 2 | 7 d | 1 | 0 | 1 | 0 | scar, smeary overlay |
| 1 | 8 d | 1 | 0 | 0 | 0 | scar |
| 2 | 8 d | 1 | 0 | 1 | 0 | scar, smeary overlay |
| mean (animal 1) | 24 - 48 h | 1 | 0 | 1 | 0 | |
| mean (animal 2) | 24 - 48 h | 1 | 0 | 2 | 0.5 | |
| mean (animal 1 - 2) | 24 - 48 h | 1.00 | 0.00 | 1.50 | 0.25 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
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