Registration Dossier
Registration Dossier
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EC number: 269-061-0 | CAS number: 68186-99-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77005.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Minor deviations with no effect on the results: - According to the guideline, both eyes should be examined regarding eye problems 24 hours before the test. It was not stated, if this was done in this study. - According to the guideline, after the substance has been placed in the conjunctival sac the eyelids are gently held together for about 1 second. This statement was missing in the report. -According to the guideline, a narrative description of the degree and nature of irritation or corrosion should be given, which is missing in this report. - Scoring according to modified Draize system (different wording).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- yes
- Remarks:
- ,see "rational for reliability"
- GLP compliance:
- yes
Test material
- Reference substance name:
- Manganese alumina pink corundum
- EC Number:
- 269-061-0
- EC Name:
- Manganese alumina pink corundum
- Cas Number:
- 68186-99-2
- Molecular formula:
- Mn(x)Al(2-x)O3 0,01≤x≤0,25
- IUPAC Name:
- Manganese aluminium corundum
- Test material form:
- solid
- Details on test material:
- - Physical state: pink, solid
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach/Main, FRG
- Weight at study initiation: mean weight of male: 2.76 kg; mean weight of females: 2.51 kg and 2.62 kg
- Housing: Individual housing of rabbits; Cage made of stainless steel with wire mesh walk floors; Floor area: 40 cm X 51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG; CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- 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): 0.1 mL bulk volume (about 66 mg of the comminuted test substance) was applied in a single application to the conjunctival sac of the right eyelid. The untreated eye served as control. - Observation period (in vivo):
- 72 hours (Readings at 1 hour; 24 hours; 48 hours and 72 hours after application)
- Number of animals or in vitro replicates:
- one male/ two females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was not washed out
SCORING SYSTEM: Scoring according to a modified Draize system
Chemosis (SW) and cornea (OP) (Opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe
Conjunctivae redness (RED):
0 = normal
1 = slight
2 = well-defined
3 = severe
Iris:
0 = normal
1 = circum-corneal injection
2 = iritis
Area of cornea invoolved (AR):
1 = > 0; < 1/4
2 = >= 1/4; < 1/2
3 = >= 1/2; < 3/4
4 = >= 3/4
Discharge (DI):
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased
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:
- At the 1-hour observation slight conjunctivae redness was observed in all rabbits . Also, slightly increased discharge was seen in all animals.
These ocular effects were not seen anymore at the 24 hour observation.
No other ocular effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
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