Registration Dossier
Registration Dossier
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EC number: 269-049-5 | CAS number: 68186-87-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77347.
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-06-11 to 2010-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
Test material
- Reference substance name:
- Cobalt zinc aluminate blue spinel
- EC Number:
- 269-049-5
- EC Name:
- Cobalt zinc aluminate blue spinel
- Cas Number:
- 68186-87-8
- Molecular formula:
- Co(x)Zn(1-x)Al2O4 0,1≤x≤0,9
- IUPAC Name:
- Cobalt zinc aluminium spinel
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Chemical description: Cobalt zinc aluminate blue spinel
- Physical state: Solid, blue powder, odourless
- Structure: spinel
- Storage condition of test material: Kept dry in closed containers
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: Approx. 2.5 - 3.5 months
- Weight at study initiation: 1.9 kg - 2.4 kg (Animal No. 1: 2.2 kg; Animal No. 2: 2.4 kg; Animal No. 3: 1.9 kg
- Housing: For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine. During the acclimatisation period and after the 8 hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm X 425 mm X 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet (ad libitum): Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany
- Water (ad libitum): Tap water
- Acclimation period: At least 20 adaption days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 3 °C (maximum range)
- Relative humidity: 30 % - 70 % (maximum range; aim was 50 % - 60 %)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item were administered into one eye each of three animals.The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. - Duration of treatment / exposure:
- 1 hour after administration the eyes were rinsed.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The test was perfrmed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 1 hour after administration
- Washing (if done): The eyes were rinsed with portions of 20 ml 0.9 % aqueous NaCl solution, each.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: The eyes were examined ophthalmoscopically with a slit lamp prior to administration and 1, 24, 48 and 72 hours after administration.
24 hours after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
OTHER OBSERVATIONS: Any further lesions not covered by the scoring system were recorded. Body weight of all animals was measured at the beginning of the study and at the end of the study. Behaviour and food consumption were monitored.
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (grade 1: Some blood vessels hyperaemic (injected)) was observed in all animals 1 hour after instillation. This effect was reversible after 24 hours.
The cornea and the irises were not affected by instillation of the test item and the fluorescein test perforemd 24 hours after instillation did not reveal any changes. - Other effects:
- No systemic intolerance reactions were observed in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EC Regulation 1272/2008 and subsequent regulations, the Pigment Al-Co-Zn is non-irritating.
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