Registration Dossier
Registration Dossier
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EC number: 226-109-5 | CAS number: 5281-04-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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:
- yes
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- calcium 3-hydroxy-4-[(1E)-2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-2-carboxylate
- Test material form:
- solid: nanoform
- Details on test material:
- - Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TK 10868 / Irgalite Rubine 6BL
- Analytical purity: 89% Pigment Red 57:1
- Substance type: red pigment
- Physical state: solid
- Purity test date: not available
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.44 kg (males) and 2.31 kg (males)
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) :ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours daily from 0800 - 1800 hours
IN-LIFE DATES: From: July 20, 1987 To: July 24, 1987
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.06 g per eye, corresponding to 0.1 mL
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Details on study design:
- The rabbits were examined, using a direct ophthalmoscope, at 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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