Registration Dossier
Registration Dossier
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EC number: 276-857-1 | CAS number: 72812-34-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- EC Number:
- 276-857-1
- EC Name:
- Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Cas Number:
- 72812-34-1
- Molecular formula:
- C32H18CrN6O8.C11H25NO.H
- IUPAC Name:
- Chromate(1-), [1-[2-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO][1-[2-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO]-, hydrogen, compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine (1:1:1)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Postfach 1755; D-88397 Biberach a.d. Riss
- Age at study initiation: 14 weeks
- Weight at study initiation: 2,86 - 3,01 kg
- Housing: Individually in stainless steel cages (size: 120 x 52 x 60 em)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 40-70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye - Duration of treatment / exposure:
- single application, no washing
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 0-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0.78
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- IRRITATION (see Appendix A, pp. 23-25)
SAVINYL BLACK RLSN showed a primary irritation score of: 0.78, when applied to the conjunctival sac of the rabbit eye.
CORROSION
No corrosion of the cornea was observed at any of the reading times.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these observation and on the refered classification criteria (EEC Commission Directive 93/21/EEC, April 27, 1993) the test article is not irritant to the eye of rabbits.
- Executive summary:
The primary irritation potential of the test substance was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand rabbits.
The treated eyes were not rinsed after substance application.
Scoring of irritation effects were performed 1, 24, 48 and 72 hours and 7 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. It was found to be 0.78 (max. 13). No staining of the cornea and conjunctivae of the treated eyes by the test article was observed. No corrosion was observed at any of the measuring intervals.
Based on these observation and on the refered classification criteria (EEC Commission Directive 93/21/EEC, April 27, 1993) the test article is not irritant to the eye of rabbits.
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