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EC number: 942-002-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 March, 1987 to 24 March, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride
- EC Number:
- 942-002-2
- Molecular formula:
- C42.53H20.97Cl1.17N15.41Na3.62O13.95S5.17
- IUPAC Name:
- Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: Approx. 12 to 14 weeks
- Weight at study initiation: 2390 to 2540 g
- Housing: The animals were housed individually in metal cages
- Diet: Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light
IN-LIFE DATES: From March 17, 1987 to March 24, 1987
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (49 mg) - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- Prior to test substance instillation, the animals were physically examined to ensure normal ocular surface integrity.
SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: Slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- In all animals slight blue staining (test substance related) in the cornea was found which impeded 1 h observation of conjunctival redness.
- Other effects:
- There were no signs of body weight variability, toxicity or mortality in any animal during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be not irritating to the eye.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance (of 100 % purity) to the eyes of New Zealand White rabbits according to OECD Guideline 405. A single ocular dose of 0.1 mL (49 mg) of test substance was applied into the conjunctival sac of right eye of each animal. The eyelids were then gently held together for one sec before releasing. The untreated eye served as control. Without washing, eyes were scored for irritation reactions at 1, 24, 48 and 72 h and 7 d post-instillation. Instillation of the test substance into the eye elicited mild conjunctival redness and chemosis. However, the mean scores of 24, 48 and 72 h in all the animals were below the threshold of significance (<2) and had resolved within 72 h after instillation. Based on these findings, the test substance was considered to be not irritating to the eye.
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